CardioFlux™ Platform Gets FDA 510(k) Clearance

CardioFlux ™: Today the company Genetesis has received FDA 510(k) clearance for its cardiac imaging platform. The company reports the platform pairs the CardioFlux ™ Magnetocardiograph with the integrated Faraday Analytical Cloud™ (FAC). Genetesis is a a medical technology company focused on using biomagnetic imaging to enable rapid, noninvasive and accurate chest pain triage.

“This milestone provides emergency room physicians and cardiologists with access to new technology tomeasure and visualize the magnetic fields produced by the heart’s natural electrical activity,” said Peeyush Shrivastava, Genetesis Co-Founder and CEO of Genetesis.

CardioFlux
CardioFlux

CardioFlux ™ technology enables simple, rapid, non-invasive cardiac imaging. CardioFlux represents a next-gen evolution of magnetocardiography (MCG); its use of optically pumped magnetometers (OPM) eliminates the need for liquid helium cooling, previously an obstacle to widescale commercial adoption of MCG. CardioFlux data is sent securely to the Faraday Analytical Cloud, from which physicians can review the functional imaging data, access a comprehensive set of web services, and hospitals can leverage an integrated billing service.

Genetesis notes an investigational study using a prototype CardioFlux device was completed at Ascension St. John Hospital’s Emergency Department Observation Unit and presented by Margarita Pena, M.D., FACEP Medical Director, Clinical Decision Unit as a plenary session of the American College Emergency Physicians (ACEP) 2018 Scientific Assembly. “Throughout the study it became evident that there is great potential for magnetocardiography and CardioFlux to positively impact the clinical workflow of patients presenting to the ED with chest pain or anginal equivalents, which represent nearly 10 million emergency room visits a year.”

“Building on the initial investigational study at Ascension St. John Hospital, we see the value in magnetocardiography (MCG) along with the 20 years of clinical investigation on the use of MCG and the diagnosis of myocardial ischemia and coronary artery disease. Ascension St. John is now collaborating with several sites to launch the largest multi-center study using MCG, to date,” said Edouard Daher, M.D., FACC, Director, Cardiac Catheterization Labortaory at Ascension St. John Hospital.

Partho Sengupta, M.D., FACC, Chief, Division of Cardiology and Director, Cardiovascular Imaging, West Virginia University Heart and Vascular Institute, JW Ruby Memorial Hospital, said, “At WVU we see the potential impact of the use of magnetocardiography and CardioFlux and are in the process of implementing the CardioFlux system to conduct a study on the broader applicability to cardiovascular and coronary artery disease.”

“These are major steps forward by the team at Genetesis. Achieving these clinical and commercial milestones enables delivery of an end-to-end medical device and cloud computing platform focused on improving patient care and reducing costs.” said John Rice, Ph.D. Chairman of the Board of Directors at Genetesis, and Director of Life Sciences, CincyTech.

Note: The CardioFlux Magnetocardiograph (MCG) is a non-invasive system that requires no patient exposure to radiation or exercise during the procedure. CardioFlux MCG™ is intended for use as a tool which non-invasively measures and displays the magnetic signals produced by the electric currents in the heart. The design leverages over forty years of clinical investigation related to the prognostic value of MCG in identifying cardiac origin chest pain1.  The system is a biomagnetic imaging tool comprising of compact magnetic shielding and highly sensitive magnetometers.

CAUTION: Investigational Device. Limited by Federal law to investigational use.

Subject to specific systems and security considerations.

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