Page 3 - Breakthrough Devices Program News Today

The only FDA cleared, single-platform technology capable of delivering rapid AST results.

A collaborative group of Cedars-Sinai investigators suggest artificial intelligence can accurately assess volume, density of heart fat-both of which are linked to cardiovascular risk

/PRNewswire/ -- SightGlass Vision, a joint venture of CooperCompanies and EssilorLuxottica that develops innovative technologies and science-based treatments...

SightGlass Vision, a joint venture of CooperCompanies and EssilorLuxottica that develops innovative technologies and science-based treatments to address the global myopia epidemic, today announced that the U.S. Food and Drug Administration (FDA) has...

This designation assures enhanced FDA cooperation and priority regulatory review of the company's novel medical solution for back pain due to degenerative disc diseaseOXFORD, England--(BUSINESS WIRE)--ORTHOSON, a medtech innovator developing a portfolio of novel treatments for back pain, today announced that its Bio...

Sanket Dhruva, MD, MHS, details examining the perspectives of physicians regarding the FDA approval process for drugs and high-risk medical devices.

/PRNewswire/ -- Amadix, a Spanish biotech company, announced today that PreveCol®, its colorectal cancer screening blood test, has received Breakthrough Device...

FDA grants global Medical Device company Biomimetic Innovations ‘Breakthrough Device’ designation for OsStic® Synthetic Injectable Structural...

Many physicians are unfamiliar with how the Food and Drug Administration’s (FDA) regulates new drugs and medical devices, and they may be under the impres

Many physicians are unfamiliar with how the Food and Drug Administration’s (FDA) regulates new drugs and medical devices, and they may be under the i