News

JD Supra1d
A need for speed: FDA piloting voucher program to expedite drug review
On July 22, 2025, the US Food and Drug Administration (FDA) started accepting applications to participate in the Commissioner’s National ...
FMIBlog1d
Implantable Drug Eluting Devices Market Outlook 2025 to 2035 Leading with REVA Medical, Inc., Alimera Sciences, Bausch and Lomb, Inc.
Drug Eluting Stents are anticipated to lead the product category, holding 34.5% of the market revenue in 2025. Their clinical demand stems from their ability to prevent restenosis and maintain ...
BioSpace1d
FDA Does 180 on Sarepta, Freeing DMD Gene Therapy for Ambulatory Patients
The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety ...
Medical Device Network on MSN2d
Stereotaxis wins FDA clearance for diagnostic mapping catheter
MAGiC Sweep is claimed to be the first robotically navigated electrophysiology mapping catheter approved by the FDA.
MassDevice4d
Medtronic takes next step to submit bone graft for new FDA indication
Infuse for TLIF initially received FDA breakthrough device designation in April 2024. A new indication could expand treatment options for spine surgery patients if approved, Medtronic says. The ...