BSI Grants ISO 13485:2003 Certification to Eclipse Aesthetics December 14, 2016 The company received QMS certification. Read More
EU Suspends Endologix’s CE Mark December 14, 2016 The device is still available in the U.S. and Japan. Read More
FDA has Regulatory Options for LDTs Even Without Final Guidance December 14, 2016 The FDA will not release final guidance on LDTs. Read More
FDA Awards Lumendi Marketing Clearance for DiLumen December 13, 2016 The device is a colonoscope accessory to aid in lesion treatment. Read More
LivaNova and Maquet Issue an Updated Safety Notice for 3T Systems December 13, 2016 The Safety notice is for potential heart infections with device use if not properly disinfected. Read More
CDSCO of India Issues Recall for JMS Infusion Set December 13, 2016 The product label is not approved by CDSCO of India for indicated shelf life. Read More
FDA Strikes Certain Data Requirements for Imported Products in Final Rule December 13, 2016 The final rule removes the requirement to submit the IND application number. Read More
FTC Charges Settled with Aura Labs on Blood Pressure Reading App Accuracy December 12, 2016 The app was allegedly marketed to replace a traditional blood pressure medical device. Read More
Boston Scientific Files Lawsuit Against Nevro December 12, 2016 The alleged infringement is against patent protection for nerve-therapy technology. Read More
Centurion Issues Recall on Multi-Med Single Lumen Catheters December 12, 2016 The catheter is used to sample blood and administer drugs or fluids. Read More
FDA Asks Industry Where to Draw the Line on Off-Label Communication December 12, 2016 AdvaMed recommends the FDA expand the scope of information to share with healthcare professionals. Read More
Provision Healthcare Obtains FDA Clearance for SC360 Therapy System December 9, 2016 The device is a patient-bed scanning radiation system that treats cancer patients. Read More