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Eye movement tracking technology developer RightEye got a Form 483 for lapses in its design controls, product handling and complaint procedures, among other deficiencies observed during a June 28 to July 8 FDA inspection of its Bethesda, Md., facility. Read More
Encore sets up a collection system with hospitals for the used robotic attachment and makes loaner instruments available during the remanufacturing process. Read More
Mytrex, a manufacturer of personal emergency response systems, received a Form 483 from the FDA for lack of equipment testing and inadequate recordkeeping, among other lapses observed during an inspection of the company’s South Jordan, Utah, facility. Read More
The EU’s Medical Device Coordination Group (MDCG) has released new guidance on requirements created by the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) for devicemakers’ “authorized representatives,” including who, when and how to register. Read More
Ionocare has received 510(k) marketing clearance from the FDA to remanufacture and market a used DaVinci robotic surgical system attachment — 8 mm monopolar curved scissors for the EndoWrist Si system. Read More
The Medical Device Innovation Consortium (MDIC) has published a new step-by-step framework approach to integrating patient preferences into medical device clinical trials. Read More
The FDA has granted Grifols marketing clearance for its AlphaID At Home direct-to-consumer screening test for alpha-1 antitrypsin deficiency, which can cause a hereditary form of emphysyma as well as cirrhosis of the liver. Read More