News

Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths
Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...
Endocrinology Advisor3d
OTC Cuffless Blood Pressure Monitoring Device Gets FDA Clearance
The FDA has cleared the Hilo Band (G0 Blood Pressure Monitoring System) for at-home blood pressure monitoring in adults.
FDA Inspectors Again Find Dangerous Breakdowns at an Indian Factory Supplying Medications to U.S. Consumers
The latest inspection comes 2 1/2 years after the agency allowed Sun Pharma to keep shipping some drugs to Americans even ...
Medical Device Network on MSN2d
UroMems awarded FDA IDE to use artificial urinary sphincter in pivotal trial
FDA's IDE approval for UroMems’ UroActive System follows strong feasibility clinical study results in both men and women.
Endovascular Today3d
Piccolo’s Second-Generation SmartPICC Technology Cleared by FDA
Piccolo Medical, Inc. announced it has received FDA 510(k) clearance to market its next-generation SmartPICC stylet and PM2+ syste ...