Coredio’s AI software is used to monitor HF parameters via wearables and standard blood pressure cuffs.

AI-powered platform uses consumer wearables to help clinicians monitor heart failure patients beyond the hospital SANTA CLARA, Calif.--(BUSINESS WIRE ...

For the United States, Breakthrough Device Designation provides Gene Solutions with a prioritized channel of engagement with ...

Freiburg, Germany, April 08, 2026 (GLOBE NEWSWIRE) -- CorTec GmbH, a pioneer in fully implantable brain-computer interfaces (BCI), today announced that the U.S. Food and Drug Administration (FDA) has ...

Atrioventricular Interval Modulation (“AVIM”) Therapy Food and Drug Administration (“FDA”) Breakthrough Device Designations span the broader population of patients with uncontrolled hypertension ...

Orchestra BioMed has announced that the FDA has granted Breakthrough Device Designation for its atrioventricular interval modulation (AVIM) therapy, aimed at treating over 7.7 million U.S. patients ...

The United States Food and Drug Administration (FDA) issued guidance on its “Breakthrough Devices Program” in 2023. The program grants a designation to certain medical devices that provide more ...

TOBY, Inc., a biotechnology company developing non-invasive disease detection technologies, today announced that the U.S.

—Breakthrough Device Designation to streamline regulatory review and support a pathway toward broader reimbursement coverage— ANDOVER, Mass. and HAIFA, Israel, March 11, 2026 /PRNewswire/ -- MeMed, a ...

DENVER, April 08, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients ...