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Effective date: July 19, 2024

Business Associate Agreement (“BAA”)

BACKGROUND

I. Covered Entity is either a “covered entity” or “business associate” of a covered entity as each are defined under the Health Insurance Portability and Accountability Act of 1986, Public Law 104-191, as amended by the HITECH ACT (as defined below) and the related regulations promulgated by HHS (as defined below) (collectively, “HIPAA”) and, as such, is required to comply with HIPAA’s provisions regarding the confidentiality and privacy of Protected Health Information (as defined below);

II. The parties have entered into or will enter into one or more agreements under which Powerful Medical as a Business Associate provides or will provide certain specified Services to you, in role of a user authorized to use the Subscription Services based on the EULA, as a Covered Entity (collectively, the “Agreement”);

III. In providing services pursuant to the Agreement (“Services”), Business Associate will have access to Protected Health Information;

IV. By providing the Services, Business Associate will become a “business associate” of the Covered Entity as such term is defined under HIPAA;

V. Both Parties are committed to complying with all federal and state laws governing confidentiality and privacy of health information, including, but not limited to, the Standards for Privacy of Individually Identifiable Health Information found at 45 CFR Part 160 and Part 164, Subparts A and E (collectively, the “Privacy Rule”); and

VI. Both Parties intend to protect the privacy and provide for the security of Protected Health Information disclosed to Business Associate pursuant to this Agreement, HIPAA and other applicable laws.

AGREEMENT

1.         Definitions. For the purposes of this BAA, the Parties give the following meaning to each of the terms in this Section 1 below. Any capitalized term used in this BAA, but otherwise defined, has the meaning given to that term in the Privacy Rule or pertinent law, or in the absence of definition therein, the meaning given to that term in the Agreement.

A.   “Affiliate” means a subsidiary or affiliate of Covered Entity that is, or has been, considered a covered entity, as defined by HIPAA.

B.   “Breach” means the acquisition, access, use, or disclosure of PHI in a manner not permitted under the Privacy Rule which compromises the security or privacy of the PHI, as defined in 45 CFR § 164.402.

C.   “Breach Notification Rule” means the portion of HIPAA set forth in Subpart D of 45 CFR Part 164.

D.   “Data Aggregation” means, with respect to PHI created or received by Business Associate in its capacity as the “business associate” under HIPAA of Covered Entity, the combining of such PHI by Business Associate with the PHI received by Business Associate in its capacity as a business associate of one or more other “covered entity” under HIPAA, to permit data analyses that relate to the Health Care Operations (defined below) of the respective covered entities. The meaning of “data aggregation” in this BAA shall be consistent with the meaning given to that term in the Privacy Rule.

E.         “Designated Record Set” has the meaning given to such term under the Privacy Rule including 45 CFR § 164.501.B.

F.         “De-Identify” means to alter the PHI such that the resulting information meets the requirements described in 45 CFR §§164.514(a) and (b).

G.   “Electronic PHI” means any PHI maintained in or transmitted by electronic media as defined in 45 CFR § 160.103

H.   “Health Care Operations” has the meaning given to that term in 45 CFR § 164.501.

I.          “HHS” means the U.S. Department of Health and Human Services.

J.         “HITECH Act” means the Health Information Technology for Economic and Clinical Act, enacted as part of the American Recovery and Reinvestment Act of 2009, Public Law 111-005.

K.   “Individual” has the same meaning given to that term in 45 CFR §§160.103 and includes a person who qualifies as a personal representative in accordance with 45 CFR § 164.502(g).

L.         “Privacy Rule” means that portion of HIPAA set forth in 45 CFR Part 160 and Part 164, Subparts A and E.

M.   “Protected Health Information” or “PHI” has the meaning given to the term “protected health information” in 45 CFR §§160.103, limited to the information created or received by Business Associate from or on behalf of the Covered Entity.

N.   “Security Incident” means the attempted or successful unauthorized access, use, disclosure, modification, or destruction of information or interference with system operations in an information system.

O.   “Security Rule” means the Security Standards for the Protection of Electronic Health Information provided in 45 CFR Part 160 & Part 164, Subparts A and C.

P.         “Unsecured Protected Health Information” or “Unsecured PHI” means any “protected health information” as defined in 45 CFR §§160.103 that is not rendered unusable, unreadable, or indecipherable to unauthorized individuals through the use of a technology or methodology specified by the HHS Secretary in the guidance issued pursuant to the HITECH Act and codified at 42 USC § 17932(h).

2.         Use and Disclosure of PHI.

A.   Except as otherwise provided in this BAA, Business Associate may use or disclose PHI as reasonably to provide the Services to Covered Entity, and to undertake other activities of Business Associate permitted or required of Business Associate by this BAA or as required by law.

B.   Except as otherwise limited by this BAA or federal or state law, Covered Entity authorizes Business Associate to use the PHI in its possession for the proper management and administration of Business Associate’s business and to carry out its legal responsibilities. Business Associate may disclose PHI for its proper management and administration, provided that (i) the disclosures are according to law; or (ii) Business Associate obtains, in writing, prior to making any disclosure to a third party (a) reasonable assurances from this third party that the PHI will be held confidential substantially to the same extent as provided under this BAA and used or further disclosed only as required by law or for the purpose for which it was disclosed to this third party and (b) an agreement from this third party to notify Business Associate immediately of any breaches of the confidentiality of the PHI, to the extent it has knowledge of the breach.

C.   Business Associate will not use or disclose PHI in a manner other than as provided in this BAA, as permitted under the Privacy Rule, or as required by law. Business Associate will use or disclose PHI, to the extent practicable, as a limited data set or limited to the minimum necessary amount of PHI to carry out the intended purpose of the use or disclosure, in accordance with Section 13405(b) of the HITECH ACT (codified as 42 USC § 17935(b)) and any of the act’s implementing regulations adopted by HHS, for each use or disclosure of PHI.

D.   Upon request, Business Associate will without undue delay make available to Covered Entity any of Covered Entity’s PHI that Business Associate or any of its agents or subcontractors have in their possession.

E.         Business Associate may use PHI to report violations of law to appropriate Federal and State authorities, consistent with 45 CFR §164.502(j)(1).

3.         Safeguards Against Misuse of PHI. Business Associate will use appropriate safeguards to prevent the use or disclosure of PHI other than as provided by the Agreement or this BAA and Business Associate agrees to implement administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity and availability of the Electronic PHI that it creates, receives, maintains or transmits on behalf of Covered Entity. Business Associate agrees to take reasonable steps, including providing adequate training to its employees to ensure compliance with this BAA and to ensure that the actions or omissions of its employees or agents do not cause Business Associate to breach the terms of this BAA.

4.         Reporting Disclosures of PHI and Security Incidents. Business Associate will report to Covered Entity in writing any use or disclosure of PHI not provided for by this BAA of which it becomes aware and Business Associate agrees to report to Covered Entity any Security Incident affecting Electronic PHI of Covered Entity of which it becomes aware. Business Associate shall report any such event without unreasonable delay, but in no case later than within 60 calendar days of becoming aware of the event.

5.         Reporting Breaches of Unsecured PHI. Business Associate will notify Covered Entity in writing promptly upon the discovery of any Breach of Unsecured PHI in accordance with the requirements set forth in 45 CFR § 164.410, but in no case later than 60 calendar days after the discovery of a Breach. Business Associate will reimburse Covered Entity for reasonable costs incurred by it in complying with the requirements of Subpart D of 45 CFR §164 that are imposed on Covered Entity as a result of a Breach committed by Business Associate.

6.         Mitigation of Disclosures of PHI. Business Associate will take reasonable measures to mitigate, to the extent practicable, any harmful effect that is known to Business Associate of any use or disclosure of PHI by Business Associate or its agents or subcontractors in violation of the requirements of this BAA.

7.         Agreements with Agents or Subcontractors. Business Associate will ensure that any of its agents or subcontractors that have access to, or to which Business Associate provides, PHI agree in writing to the restriction and conditions concerning uses and disclosures of PHI contained in this BAA and agree to implement reasonable and appropriate safeguards to protect any Electronic PHI that it creates, received, maintains or transmits on behalf of Business Associate or, through the Business Associate, Covered Entity. Business Associate shall notify Covered Entity, or upstream Business Associate, of all subcontracts and agreements relating to the Agreement, where the subcontractor or agent received PHI as described in section 1.M of this BAA. Such notification shall occur within 30 calendar days of the execution of the subcontract by placement of such notice on the Business Associate’s primary website. Business Associate shall ensure that all subcontracts and agreements provide the same level of privacy and security as this BAA.

8.         Access to PHI by Individuals.

A.   Upon request, Business Associate agrees to furnish Covered Entity with copies of the PHI maintained by Business Associate in a Designated Record Set within 15 calendar days in the manner designated by Covered Entity to enable Covered Entity to respond to an Individual’s request for access to PHI under 45 CFR §164.524.

B.   In the event any Individual or personal representative requests access to the Individual’s PHI directly from Business Associate, Business Associate within 15 calendar days, will forward that request to Covered Entity. Any disclosure of, or decision not to disclose, the PHI requested by an Individual or a personal representative and compliance with the requirements applicable to an Individual’s right to obtain access to PHI shall be the sole responsibility of Covered Entity.

9. Amendment of PHI.

A.   Upon request and instruction from Covered Entity, Business Associate will amend PHI or a record about an Individual in a Designated Record Set that is maintained by, or otherwise within the possession of, Business Associate as directed by Covered Entity in accordance with procedures established by 45 CFR §164.526. Any request by Covered Entity to amend such information will be completed by Business Associate within 30 calendar days of Covered Entity’s request.

B.   In the event that any Individual requests that Business Associate amend such Individual’s PHI or record in a Designated Record Set, Business Associate within 15 calendar days will forward this request to Covered Entity. Any amendment of, or decision not to amend, the PHU or record as requested by an Individual and compliance with the requirements applicable to an Individual’s right to request an amendment of PHI will be the sole responsibility of Covered Entity.

10. Accounting of Disclosures.

A.   Business Associate will document any disclosures of PHI made by it to account for such disclosures as required by 45 CFR §164.528(a). Business Associate also will make available information related to such disclosures as would be required for Covered Entity to respond to a request for an accounting of disclosures in accordance with 45 CFR §164.528. At a minimum, Business Associate will furnish Covered Entity the following with respect to any covered disclosures by Business Associate: (i) the date of disclosure of PHI; (ii) the name of the entity or person who received PHI, and, if known, the address of such entity or person; (iii) a brief description of the PHI disclosed; and (iv) a brief statement of the purpose of the disclosure which includes the basis for such disclosure.

B.   Business Associate will furnish to Covered Entity information collected in accordance with this Section 11, within 30 calendar days after written request by Covered Entity, to permit Covered Entity to make an accounting of disclosures as required by 45 CFR §164.528, or in the event that Covered Entity elects to provide an Individual with a list of its business associates, Business Associate will provide an accounting of its disclosures of PHI upon request if the Individual, if and to the extent that such accounting is required under the HITECH ACT or under HHS regulations adopted in connection with the HITECH ACT.

C.   In the event an Individual delivers the initial request for an accounting directly to Business Associate, Business Associate will within 15  calendar days forward such request to Covered Entity.

11. Availability of Books and Records. Business Associate will make available its internal practices, books, agreements, records, and policies and procedures relating to the use and disclosure of PHI, upon request, to the Secretary of HHS for purposes of determining Covered Entity’s and Business Associate’s compliance with HIPAA, and this BAA.

12. Responsibilities of Covered Entity. With regard to the use and/or disclosure of Protected Health Information by Business Associate, Covered Entity agrees to:

A.   Notify Business Associate of any limitation(s) in its notice of privacy practices in accordance with 45 CFR §164.520, to the extent that such limitation may affect Business Associate’s use or disclosure of PHI.

B.   Notify Business Associate of any changes in, or revocation of, permission by an Individual to use or disclose Protected Health Information, to the extent that such changes may affect Business Associate’s use or disclosure of PHI.

C.   Notify Business Associate of any restriction to the use or disclosure of PHI that Covered Entity has agreed to in accordance with 45 CFR §164.522, to the extent that such restriction may affect Business Associate’s use or disclosure of PHI.

D.   Except for data aggregation or management and administrative activities of Business Associate, Covered Entity shall not request Business Associate to use or disclose PHI in any manner that would not be permissible under HIPAA if done by Covered Entity.

13. Data Ownership. Business Associate’s data stewardship does not confer data ownership rights on Business Associate with respect to any data shared with it under the Agreement, including any and all forms thereof.

14. Term and Termination.

A.   This BAA will become effective on the date of first processing of PHI by Business Associate on behalf of Covered entity and shall remain in effect until all obligations of the Parties have been met under the Agreement and under this BAA.

B.   Covered Entity may terminate this BAA, the Agreement, and any other related agreements if Covered Entity makes a determination that Business Associate has breached a material term of this BAA and Business Associate has failed to cure that material breach, to Covered Entity’s reasonable satisfaction, within 30 calendar days after written notice from Covered Entity. Covered Entity may report the problem to the Secretary of HHS if termination is not feasible.

C.   If Business Associate determines that Covered Entity has breached a material term of this BAA, then Business Associate will provide Covered Entity with written notice of the existence of the breach and shall provide Covered Entity with 30 calendar days to cure the breach. Covered Entity’s failure to cure the breach within the 30-day period will be grounds for immediate termination of the Agreement and this BAA by Business Associate. Business Associate may report the breach to the HHS.

D.   Upon termination of the Agreement or this BAA for any reason, all PHI maintained by Business Associate will be returned to Covered Entity or destroyed by Business Associate. Business Associate will not retain any copies of such information. This provision will apply to PHI in the possession of Business Associate’s agents and subcontractors. If return or destruction of the PHI is not feasible, in Business Associate’s reasonable judgment, Business Associate will furnish Covered Entity with notification, in writing, of the conditions that make return or destruction infeasible. Upon mutual agreement of the Parties that return or destruction of the PHI is infeasible, Business Associate will extend the protections of this BAA to such information for as long as Business Associate retains such information and will limit further uses and disclosures to those purposes that make the return or destruction of the information not feasible. The Parties understand that this Section 14.D. will survive any termination of this BAA.

15. Effect of BAA.

A.   This BAA is a part of and subject to the terms of the Agreement, except that to the extent any terms of this BAA conflict with any term of the Agreement, the terms of this BAA will govern.

B.   Except as expressly stated in this BAA or as provided by law, this BAA will not create any rights in favor of any third party.

16. Regulatory References. A reference in this BAA to a section in HIPAA means the section as in effect or as amended at the time.

17. Notices. All notices, requests and demands or other communications to be given under this BAA to a Party will be given as follows:

A.   If to Covered Entity, to: e-mail address provided to the Business Associate for creation of an account to the Subscription Services

B.   If to Business Associate, to:  legal@powerfulmedical.com, or to Powerful Medical Inc.,
33 W 17th St 7th Floor, New York, NY 10011, United States

18. Amendments and Waiver. This BAA may not be modified, nor will any provision be waived or amended, except in writing duly signed by authorized representatives of the Parties. A waiver with respect to one event shall not be construed as continuing, or as a bar to or waiver of any right or remedy as to subsequent events.

19. HITECH ACT Compliance. The Parties acknowledge that the HITECH Act includes significant changes to the Privacy Rule and the Security Rule. The privacy subtitle of the HITECH Act sets forth provisions that significantly change the requirements for business associates and the agreements between business associates and covered entities under HIPAA and these changes may be further clarified in forthcoming regulations and guidance. Each Party agrees to comply with the applicable provisions of the HITECH Act and any HHS regulations issued with respect to the HITECH Act. The Parties also agree to negotiate in good faith to modify this BAA as reasonably necessary to comply with the HITECH Act and its regulations as they become effective but, in the event that the Parties are unable to reach an agreement on such a modification, either Party will have the right to terminate this BAA upon 30 calendar days’ prior written notice to the other Party.

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Powerful Medical is redefining the landscape of medical diagnostics with its AI-driven solutions. The company’s PMcardio platform deploys certified AI-ECG Modules that revolutionize the way cardiovascular diseases are detected, offering rapid and accurate diagnostics that pave the way for timely and effective treatment.

 

  • © Powerful Medical 2026
Powerful Medical, Inc. | PMcardio and the PMcardio logo are registered trademarks of Powerful Medical. Additionally, Queen of Hearts is claimed as a trademark of Powerful Medical.

Certain AI ECG Modules are CE-marked medical devices under EU MDR and only certified for marketing in the European Union and the United Kingdom. Powerful Medical technology has not yet been cleared or approved by the US Food and Drug Administration (FDA) for marketing in the USA. Not all modules of the PMcardio platform may be available in your region.

Prior to use, reference the Instructions for Use, for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
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Suites

Five suites.
One platform.
The full cardiac care journey.

PMcardio’s clinical suites cover the full spectrum of cardiac care — from acute emergency detection to longitudinal monitoring. Deploy the suites that match your priorities today, expand as your needs grow.

Minutes matter

Acute Care Suite

AI-powered detection and pathway coordination for time-critical cardiac events — including STEMI and OMI, pulmonary embolism / RV strain, and hyperkalemia.

  • stemi/OMI
  • pe/RV strain
  • hyperK

Find what ECGs Hide

Echo Screening Suite

AI-powered screening for structural heart disease directly from a 12-lead ECG — detecting reduced LVEF, aortic stenosis, HCM, and other SHD conditions that traditional ECG interpretation misses.

  • lvef
  • aortic stenosis
  • hcm

Ambulatory, automated

Remote Monitoring Suite

AI-powered analysis of ambulatory ECG recordings — Holter monitors, cardiac patches, and other continuous monitoring devices — with automated findings and longitudinal tracking.

  • holter
  • cardiac patches
  • arrhythmia burden

Beyond the clinic

Patient Suite

AI-powered ECG interpretation for consumer wearables and patient-facing devices — extending cardiac care beyond the clinic into everyday life.

  • wearable ECG Analysis
  • PPG Analysis

On-table intelligence

Angio Suite

AI-powered analysis of coronary angiography — automated stenosis quantification, TIMI frame count, guide wire detection, and myocardial blush grading in near real-time.

  • vessel segmentation
  • stenosis quant.
  • timi frames
  • blush grading

Governance, customization & configuration

Align the platform to your protocols — without a custom software project.

Configure escalation thresholds, roles, and reporting to match local pathway rules — while maintaining system-wide governance and consistency.

  • Configurable triggers, roles, and escalation workflows
  • Custom dashboards and views aligned to leadership needs
  • Controlled expansion to additional pathways over time

Outcomes, QA & performance intelligence​

Measure what matters — across every pathway, every site.

Turn pathway execution into dashboards and reporting that help leadership reduce variation, optimize time-to-treatment, and demonstrate value across every deployed suite.

  • Cross-site, cross-pathway, and team-level benchmarking
  • Time-to-treatment and pathway quality tracking
  • QA workflows, audit trails, and leadership reporting
  • Registry-aligned reporting support (NCDR Chest Pain-MI, AHA GWTG, and more)

Escalation & care coordination

Real-time routing that matches how your system actually runs.

Route critical cases to the right team with role-based notifications, escalation logic, and shared case context — across EMS, ED, cardiology, cath lab, and inpatient care.

  • Role-based alerting and escalation across departments and sites
  • Shared case context so receiving teams have what they need before the patient arrives
  • Integration with existing communication and alerting tools

AI-powered decision support

Clinically validated AI that spans the cardiac care journey.

Run multiple AI models on every recording — acute detection, screening, procedural quantification — with interpretable outputs and case-level explainability.

  • Queen of Hearts™ for STEMI/OMI detection
  • LVsense™ for reduced ejection fraction
  • Culprit Artery Prediction for pre-cath planning
  • Core AI for comprehensive rhythm and conduction analysis
  • Expanding model portfolio across Echo Screening, Remote Monitoring, and Angio Suites

Interoperability & deployment

Connect across your existing systems — without replacing them.

Ingest pathway-critical inputs from across your network and IT landscape, and deliver results where teams already work. Built for system-wide rollout with enterprise deployment patterns.

  • Connect to ECG devices, angiographic systems, and ambulatory monitors across sites
  • Launch PMcardio from the EHR / CVIS with secure links and SSO
  • Send results back to clinical systems where care is documented

All Supported ECG Findings

Rhythms
Sinus bradycardia • Sinus rhythm • Sinus tachycardia • Paced rhythm • Atrial fibrillation
Atrial fibrillation with rapid ventricular response • Atrial fibrillation with slow ventricular response • Atrial flutter • Atrial flutter with rapid ventricular response • Atrial flutter with slow ventricular response • Supraventricular tachycardia • Suspected junctional rhythm • Suspected junctional bradycardia • Suspected accelerated junctional rhythm • Wide QRS rhythm • Idioventricular rhythm • Wide QRS tachycardia

Myocardial Infarctions

  • STEMI
  • STEMI Equivalent
    Equivalent
Detects occlusive myocardial infarctions (OMIs) even without ST elevation (i.e. posterior STEMI, hyperacute T-waves, etc.). Negative for STEMI mimics (i.e. early repolarization, LVH, etc.)
  • High-Risk NSTEMI
    Represents a type 1 myocardial infarction caused by a transiently recanalized coronary occlusion—classically seen in patterns such as Wellens type A or B due to subtotal LAD obstruction, but possible in any infarct-related territory.
  • Culprit Detection
    AI-predicted likelihood scores for LAD, LCx, and RCA with 3D heart visualization highlighting the predicted culprit artery.

Conduction Abnormalities (Heart Blocks
1st degree AV block • 2nd degree AV block, type Wenckebach • Higher degree AV block • Complete right bundle branch block • Incomplete right bundle branch block • Complete left bundle branch block • Incomplete left bundle branch block • Nonspecific intraventricular conduction delay • Left anterior fascicular block • Left posterior fascicular block • Bifascicular block (RBBB + LAFB) • Bifascicular block (RBBB + LPFB) • Trifascicular block (RBBB + LAFB + AVBLOCK1) • Trifascicular block (RBBB + LPFB + AVBLOCK1)

LVEF
Reduced LVEF (≤40%) • Mildly reduced LVEF (41 – 49%) • No signs of reduced LVEF (≥50%)

Axis
Left cardiac axis deviation • Right cardiac axis deviation • Extreme cardiac axis deviation • Normal axis

Measurements
Heart rate • P wave • PR interval • QRS duration • QT interval • Corrected QT interval (Framingham formula) • RR interval • PP interval • ST elevations

Other Supported Diagnoses
Suspected long QT syndrome • Suspected short QT syndrome • Suspected atrial enlargement • Suspected ventricular hypertrophy • Premature complexes

Certain AI ECG Modules are CE-marked medical devices under EU MDR and only certified for marketing in the European Union and the United Kingdom. Powerful Medical technology has not yet been cleared or approved by the US Food and Drug Administration (FDA) for marketing in the USA. Not all modules of the PMcardio platform may be available in your region.

Dr. Tom De Potter, MD

Cardiologist at the Cardiac Center Aalst

Cardiologist specializing in Pacemaker Device Therapy and Electrophysiology. Leads the electrophysiology unit at the Heart Center in Aalst, holds an executive board position at the European Heart Academy, and serves as EHRA scientific program committee co-chair.

Dr. Martin Penicka, MD, PhD

Cardiologist at the Cardiac Center Aalst

Cardiologist at the Cardiac Center Aalst since 2009, specializing in non-invasive imaging and valvular disease. Fellow of the European Society of Cardiology (FESC) and the European Association of Cardiovascular Imaging (FEACVI).

Dr. Ward Heggermont, MD, PhD

Co-director at the Cardiovascular Center

Co-director at the Cardiovascular Center of Aalst Hospital, specializing in heart failure. Research focus at the intersection of cardiology, virology, and metabolism.

Prof. Dr. Robert Hatala, PhD

Co-founder and Chief Scientist

Head of the Arrhythmia and Pacing department at the National Institute of Cardiovascular Diseases in Slovakia. More than 150 publications and 10,000 citations. Contributor to ESC clinical practice guidelines and executive editor of the European Heart Journal since 2020.

Arieh Levy

Head of PMcardio for Individuals

Arieh leads the PMcardio for Individuals product at Powerful Medical, guiding its development as a clinical tool for emergency physicians, cardiologists, and primary care physicians. He holds a First Class MEng in Biomedical Engineering from Imperial College London, where he specialised in AI for cardiology, building physics-informed neural networks to model atrial electrical properties, giving him a background that bridges the clinical and technical demands of building a certified AI medical device used at the bedside every day.

Dr. Dave Pearson, MD​

Business Advisor

Academic emergency medicine physician, entrepreneur, investor, and researcher with nearly two decades at Atrium Health, one of US largest health systems. Brings expertise at the intersection of clinical care, healthcare innovation, and strategic leadership.

Prof. Stephen W. Smith, MD

Professor of Emergency Medicine

Faculty physician in Emergency Medicine at Hennepin County Medical Center and Professor of Emergency Medicine at the University of Minnesota. Co-inventor of the OMI paradigm and editor of Dr. Smith’s ECG Blog, the most-visited US-based ECG interpretation blog.

Prof. Emanuele Barbato, MD, PhD

President of EAPCI

Interventional cardiologist specializing in coronary artery disease and coronary physiology. Acting president of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and contributor to the clinical practice guidelines for STEMI care.

Scott Sharkey, MD

Chief Medical Officer

Chief Medical Officer of the Minneapolis Heart Institute Foundation and practicing cardiologist at Allina Health Minneapolis Heart Institute. Co-founder of the STEMI Midwest consortium and Takotsubo cardiomyopathy research program and a widely published clinical investigator in STEMI care.

Prof. Dr. Leor Perl, MD

Director of Cardiac Catheterization Institute

Director of Complex Cardiac Interventions and Chief Innovation Officer at Rabin Medical Center. Graduate of the Stanford Biodesign Program.

Suzanne J. Baron, MD, MSc

Director of Interventional Cardiology Research

Director of Interventional Cardiology Research at Massachusetts General Hospital. Holds a Master’s degree in health economics from Harvard School of Public Health. Expert in cardiovascular device impact on healthcare costs and patient-reported outcomes.

Prof. Marco Valgimigli, MD

Deputy Chief Cardiocentro Ticino Institute

Head of Cardiology at Cardiocentro Ticino and Principal Investigator of the TITAN-OMI randomized controlled trial. His research has shaped both European and US clinical practice guidelines on coronary stents, antithrombotic therapy, and vascular access.

Timothy D. Henry, MD

Medical Director of The Carl and Edyth Lindner Center

Leading expert in interventional cardiology and STEMI treatment. Co-founder and principal investigator of the Midwest STEMI Consortium, a registry of more than 20,000 consecutive STEMI activations. Presenting author for the TCT 2025 Late-Breaking Clinical Science on Queen of Hearts.

Matus Horvath

Head of People

Matus leads hiring strategy and culture at Powerful Medical, bringing a strong track record of building and scaling high-performing teams. He previously ran the People Team at Slido, the SaaS startup acquired by Cisco, where he played a key role in scaling a fast-growing, values-driven organization. His broader experience now shapes Powerful Medical’s growth, culture, and talent strategy.

Dr. Timea Kisova, MD

Clinical Research Lead

Timea leads Powerful Medical’s global external validation studies, including the multi-country AI ECG TIMI Study. With a background in biomedical sciences and a medical degree from Barts and The London School of Medicine and Dentistry, she brings the clinical discipline required to generate the prospective, real-world evidence behind every PMcardio module.

Dr. Anthony Demolder, MD, PhD

HF Pathway Lead

Research physician with a PhD on arrhythmias in heritable thoracic aortic disease. He has led international studies at the intersection of cardiology and AI — including earlier work on atrial fibrillation at AZ Sint-Jan Brugge — and now drives Powerful Medical’s heart failure pathway and LVsense™ AI model development.

Dr. Pendell Meyers, MD

ACS Pathway Lead

Emergency medicine physician, prolific educator, and Co-Editor of Dr. Smith’s ECG Blog. He is one of the leading voices behind the Occlusion Myocardial Infarction (OMI) paradigm, the clinical framework that reshaped how heart attacks are identified from the ECG — and which sits at the core of the Queen of Hearts™ model.

Adam Dej

Head of PMcardio for Organizations Engineering

Adam leads engineering for PMcardio for Organizations at Powerful Medical, driving platform architecture, backend systems, and infrastructure behind one of the company’s key growth products. He began programming at 13, entered professional IT at 17, and studied computer security at Comenius University’s Faculty of Mathematics, Physics and Informatics. Known for technical depth across distributed systems, infrastructure, and security, he builds scalable and resilient software with a sharp focus on customer impact. He also champions responsible use of AI and LLMs as force multipliers for modern engineering teams.

Gabriela Rovder Sklencarova

Head of Infrastructure

Gabriela designs the scalable, secure, distributed systems that keep PMcardio running around the clock for clinicians worldwide. She joined from Google, where she was a senior software engineer building core libraries that kept Google’s services resilient against billions of requests, and holds a BA and MA in Computer Science from the University of Cambridge.

Arezou Azar

US and Global Regulatory

Arezou leads Powerful Medical’s global regulatory strategy across the FDA, EU MDR, and international frameworks. She has been part of nearly every major breakthrough in AI cardiology and is an expert in US and global regulatory strategy, SaMD/digital health launches, with experience at Eko Health, Verily, AliveCor, Cardiologs, and Apple. She specializes in regulatory strategy in high-paced global organizations.

Adam Rafajdus

Head of AI

Adam is the Head of AI at Powerful Medical, working across the full lifecycle of bringing AI into clinical practice – from data infrastructure and model development to regulatory clearance. He leads the team behind the Queen of Hearts™ AI ECG models, the company’s ECG digitization pipeline, and its broader AI portfolio. Focused on AI since university, Adam joined as an MLOps Engineer and has grown into his current role over six years.


Mike Wall

VP of Sales

Mike brings more than twenty years at UnitedHealth Group to the table, where he served health plans, employer groups, and public-sector entities as a consultative healthcare sales executive. He combines market intelligence, clinical insight, and financial acumen — the three ingredients needed to bring AI-powered diagnostics into US health systems at scale.

Amani Farid

Head of Strategic Partnerships

Amani leads partnership strategy with a hands-on approach to integration, unlocking long-term value through collaboration and scale. A University of Chicago Law School-trained attorney and former M&A and capital markets associate at two top international law firms, she brings the rare combination of legal precision and commercial execution refined across nearly a decade at Stryker and as VP of Corporate Development at RapidAI — spanning medtech, digital health, and AI-driven diagnostics.

Michal Martonak

Commercial Lead

A mathematician by training, Michal leads commercial strategy, go-to-market, and strategic partnerships with healthcare providers and clinical institutions worldwide. He previously built Powerful Medical’s data and clinical partnerships function, acquiring the large-scale clinical datasets that underpin the company’s certified AI models.

Dr. Jozef Bartunek, MD, PhD

Co-founder and VP Clinical Strategy

Interventional cardiologist and Co-director of the Cardiovascular Center in Aalst, Belgium — one of the world’s leading heart centers. A Fogarty International NIH Fellow at Harvard Medical School and visiting Professor of Medicine at Catholic University Leuven, he has authored more than 240 peer-reviewed publications in heart failure and structural heart disease, and anchors Powerful Medical’s clinical and research strategy.

Simon Rovder

Co-founder and CTO

Simon began his engineering career at Microsoft and holds a Master’s degree in Informatics from the University of Edinburgh. He built and scaled Powerful Medical’s technology organization from the ground up to a team of 20+ engineers, leading the architecture of a CE-certified Class IIb medical device now deployed in hospitals across Europe.

Viktor Jurasek

Co-founder and CPO

Viktor was modding computer games before his teens and has spent the last decade shipping digital products across advertising, finance, and healthcare. As co-founder and CPO, he has led PMcardio’s product and design since the first prototype, setting the bar for how a clinical-grade tool should feel in a physician’s hands — fast, clear, and trustworthy at the point of care.

Felix Bauer

Co-founder and COO

Felix was part of the Hyperloop team that repeatedly competed and won in Elon Musk’s SpaceX Hyperloop Pod Competition. He holds a degree from the Technical University of Munich and brings a rare combination of engineering rigor, regulatory discipline, and operational excellence to the company, spearheading operations, compliance, regulatory, quality management, and global market access since day one.

Dr. Robert Herman, MD, PhD

Co-founder and Chief Medical Officer

Robert is a physician-scientist who served on the Research, Digital and Innovation Committee of the European Society of Cardiology. He bridges medicine and AI, connecting clinicians, researchers, regulators, and trial leaders to translate algorithms into clinical practice. He founded multiple AI ECG models, leads international clinical trials validating them, is a recipient of the Journal of the American College of Cardiology Spencer King Award, and was named to Forbes 30 Under 30 Europe 2024.

Martin Herman

Co-founder and CEO

Martin started coding at 14 and moved to Silicon Valley at 18, founding several companies including a US-based startup before returning to Europe with his brother Robert to build Powerful Medical. He comes from a family of doctors, which shaped his conviction that AI belongs wherever it can genuinely save lives. Forbes 30 Under 30 (Europe 2024).

Heart Attacks are #1 cause of death world-wide and killing about 12 milions people a year.

Clinical Definition of Problem

Contrary to popular belief, a heart attacks isn’t a blockage inside of the heart. A heart attack is a blockage of the coronary arteries supplying the heart muscle with oxygenated blood.

So let’s assume you get a blood clot here — it blocks the blood flow downstream, meaning the heart muscle doesn’t get oxygenated blood and heart tissue downstream starts to die.

Clinical Solution​

The way to fix it is relatively simple – doctors put in a stent that opens up the artery and renews blood flow. The latest clinical practice guidelines recommend that this “stenting” happens within 90 minutes from symptom onset.

If you don’t, even if you put in the stent in later, the heart tissue downstream has already been permanently damaged, which reduces the heart’s ability to pump blood. This is the leading cause of heart failure and increases 1-year mortality by two-fold.

Time is muscle.

You have just 90 minutes to diagnose the patient, bring them to the hospital and put in the stent, otherwise there is permanent damage. So problem is, that 1 in 2 heart attacks get initially misdiagnosed at the first point of contact.

Discover the future of medical work with us.

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