Fierce Healthcare

CMS, FDA announce new program to speed up Medicare coverage of breakthrough medical devices

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

Medtronic wins FDA breakthrough nod for Sphere-9 catheter, reports new clinical milestones for Affera

Medtronic (NYSE:MDT) today announced new milestones for its Affera family of technologies, including FDA breakthrough device ...
Business Insider

CorTec Receives FDA Breakthrough Device Designation for Its Brain Interchange System in Stroke Rehabilitation — the First BCI Worldwide Designated for Stroke Motor Rehabilitation

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 ...
Labroots

FDA Grants "Breakthrough Device Designation" for Early Cancer Detection Test

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

Noah Labs lands FDA breakthrough designation for AI voice-based heart failure monitor

Add Yahoo as a preferred source to see more of our stories on Google. The US Food and Drug Administration (FDA) has granted Noah Labs breakthrough device designation for a remote patient monitoring ...
Nasdaq

Ceribell Receives FDA Breakthrough Device Designation for LVO Stroke Detection and Monitoring Solution

Clearance would position the Ceribell System as the first and only point-of-care electroencephalography (EEG) technology to aid in detection and monitoring of Large Vessel Occlusion (LVO) stroke in ...
Morningstar

FDA Grants Breakthrough Device Designation to Two Rapid Tests Targeting Critical Drug-Resistant Pathogens

SANTA MARIA, Calif. and GUIPRY, France, Feb. 18, 2026 /PRNewswire/ -- In a major step forward against Antimicrobial Resistance (AMR), NG Biotech, in partnership with Hardy Diagnostics, announced today ...
Morningstar

FDA Grants Breakthrough Device Designation to MeMed BV Flex™ Capillary Blood

—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 ...

TOBY Receives FDA Breakthrough Device Designation for Its Urine-Based Multi-Cancer Early Detection (MCED) Test

TOBY, Inc., a biotechnology company developing non-invasive cancer screening technologies, today announced that the U.S. Food ...
Zanesville Times Recorder

BioAgilytix Labs, Inc Receives FDA Breakthrough Device Designation for Anti-AAV Antibody Assay

FDA grants Breakthrough Device Designation to BioAgilytix’s anti-AAV antibody assay supporting Lexeo’s gene therapy for Friedreich ataxia. DURHAM, NC, UNITED ...