Therapy Food and Drug Administration (“FDA”) Breakthrough Device Designations span the broader population of patients with uncontrolled hypertension despite medication at increased cardiovascular risk ...
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 ...
—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 ...
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 ...
We are grateful for this Breakthrough Device Designation from the FDA, recognizing that the patients we serve cannot ...
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 ...
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 ...
The Catalyst Fracture System received the prestigious “Medical Device Engineering Breakthrough” award in the 10th annual ...
Capitan Orthopedics, Inc. ( announced today that it has been granted Breakthrough Device Designation from the U.S. Food & Drug Administration (FDA) for its SupraSpacerTM implant.
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