PMcardio receives FDA Breakthrough Device Designation — read the full story
Powerful Medical
11. September 2024

Powerful Medical Achieves SOC 2 Type II and HIPAA Compliance Through External Audit

Powerful Medical is proud to announce the successful completion of both SOC 2 Type II and HIPAA compliance audits conducted by the globally recognized audit firm BDO. This achievement underscores our unwavering commitment to upholding the highest standards of data security, privacy, and operational excellence in the healthcare technology sector.

Independent Verification of Data Security and Privacy Controls

Achieving SOC 2 Type II certification demonstrates that Powerful Medical has established and maintained rigorous controls across critical areas such as security, availability, processing integrity, confidentiality, and privacy. This independent assessment affirms that our systems and processes not only meet but surpass the stringent criteria necessary to ensure the protection of sensitive information in a healthcare environment.

Additionally, obtaining HIPAA compliance confirms that we adhere to the comprehensive regulatory framework required for safeguarding protected health information (PHI) in the United States. Both certifications reflect our proactive approach to maintaining compliance with international and national data protection standards, which are essential for ensuring the security of patient data and the trust of our partners and clients.

Security & privacy standards
that keep your data safe

Fostering Innovation Through Compliance and Reliability

As a leader in AI-powered medical technologies, Powerful Medical is dedicated to driving innovations that improve patient outcomes while adhering to the most stringent regulatory standards. These certifications not only validate our robust internal controls but also serve as a testament to our ongoing commitment to transparency, security, and data integrity in the medical device sector.

In a landscape where data security and privacy are paramount, achieving SOC 2 Type II and HIPAA compliance strengthens our position as a trusted partner to healthcare providers, regulatory bodies, and patients worldwide. These certifications are now available for review in our Trust Center, offering full visibility into the measures we have implemented to safeguard sensitive information.

A Commitment to Trust and Excellence

At Powerful Medical, we believe that trust and innovation go hand-in-hand. By continuously refining our security practices and achieving critical compliance milestones, we remain at the forefront of delivering secure, compliant, and transformative healthcare technologies.

Powerful Medical

Powerful Medical leads one of the most important shifts in modern medicine by augmenting human-made clinical decisions with artificial intelligence. Our primary focus is on cardiovascular diseases, the world’s leading cause of death.
Powerful Medical leads one of the most important shifts in modern medicine by augmenting human-made clinical decisions with artificial intelligence. Our primary focus is on cardiovascular diseases, the world’s leading cause of death.
About PMcardio:

PMcardio is the market leader in AI-powered diagnostics, addressing the world’s leading cause of death – cardiovascular diseases. The innovative clinical assistant empowers healthcare professionals to detect up to 40 cardiovascular diseases. In the form of a smartphone application, the certified Class IIb medical device interprets any 12-lead ECG image in under 5 seconds to provide accurate diagnoses and individualized treatment recommendations tailored to each patient.

About Powerful Medical:

Established in 2017, Powerful Medical has embarked on a mission to revolutionize the diagnosis and treatment of cardiovascular diseases. We are a medical company backed by 28 world-class cardiologists and led by our expert Scientific Board with decades of experience in daily patient care, clinical research, and medical devices. The results of our research are implemented, developed, certified, and brought to market by our 50+ strong interdisciplinary team of physicians, data scientists, AI experts, software engineers, regulatory specialists, and commercial teams.

Share this article

Don't miss these

Powerful Medical Receives FDA Breakthrough Device Designation for PMcardio STEMI AI ECG Model

Powerful Medical, a leader in AI-driven cardiovascular diagnostics, announces that its PMcardio STEMI AI ECG model has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This designation recognizes PMcardio as a breakthrough technology for the detection of ST-elevation myocardial infarction (STEMI) and STEMI equivalents—a life-threatening cardiac condition requiring immediate intervention.
ACC_2025

Powerful Medical at ACC 2025: Advancing AI in Cardiovascular Care

We are excited to announce that Powerful Medical will be attending the American College of Cardiology (ACC) 2025 Conference, taking place from March 29th – 31st, 2025, in Chicago, IL, USA. Once again, we have a strong presence at the conference, with multiple papers being presented, underscoring our continued leadership in AI-driven cardiovascular diagnostics.

Join 25,000 healthcare professionals who are already taking advantage of AI