Therapy Food and Drug Administration (“FDA”) Breakthrough Device Designations span the broader population of patients with uncontrolled hypertension despite medication at increased cardiovascular risk ...

Orchestra BioMed (Nasdaq:OBIO) announced today that it received a second FDA breakthrough device designation for its AVIM ...

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.

The implant functions by providing support within the joint, preventing the humerus from shifting upwards.

Medical device firm Capitan Orthopedics received breakthrough device designation from the FDA for its SupraSpacer implant. The designation applies to the company’s implant designed to treat ...

Laguna Diagnostics, LLC today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company's mRNA Gene Biomarker Test, a novel blood-based test ...

The United States Food and Drug Administration (FDA) issued guidance on its “Breakthrough Devices Program” in 2023.  The ...

Add Yahoo as a preferred source to see more of our stories on Google. CorTec’s brain-computer interface (BCI) has obtained breakthrough device designation from the US Food and Drug Administration (FDA ...

—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 ...

The Centers for Medicare and Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced on Thursday ...

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 ...