Douglas Medical Products Wins FDA 510(k) Clearance for IV Administration Set September 15, 2017 The company said it will launch the product immediately. Read More
Pulse Biosciences Pulls FDA 510(k) Application September 14, 2017 The company plans to re-file with additional information. Read More
Leica Wins FDA Clearance for Novel Microscopy Filter September 14, 2017 The device combines two illumination methods. Read More
FDA Releases Guidance on Interoperable Devices September 13, 2017 The final guidance includes recommendations for labeling and premarket submissions. Read More
Gecko Biomedical Receives CE Mark Approval for SETALUM Sealant September 13, 2017 The sealant is the most recent successful example of bio-inspired technology in medicine. Read More
FDA to Pilot New High-Risk PMA for Medical Devices September 13, 2017 Participants in the PMA CtQ program would agree to post-approval inspections. Read More
Migraine Treatment Device Wins Marketing Clearance September 12, 2017 Devicemaker eNeura received 510(k) clearance from the FDA for the eNeura Spring TMS for treatment of migraine headache. Read More
FDA Hits Healthline Medical Products for Numerous Deficiencies September 8, 2017 The firm’s records of complaint evaluations did not consistently include all relevant details of the complaint and the investigation. Read More
FDA Flags Florida Facility for CAPA Procedures, Complaints September 8, 2017 The complaint files lacked key information. Read More
Dextera Surgical Wins Expanded FDA Clearance for MicroCutter 5/80 Stapler September 7, 2017 The expanded indication represents an additional 44,000 procedures in the United States annually. Read More
Adherium Receives FDA 510(k) Clearance for Next Generation Smartinhaler September 6, 2017 The device stores the history of patient medication usage patterns. Read More
Singapore Launches Device Priority Reviews, Pre-Market Consultations September 1, 2017 Devices can qualify for the priority review pathway if they address priority healthcare areas. Read More