Southeastern Technology Gets 483 for Personnel Training July 27, 2017 The facility did not maintain documented personnel training records. Read More
Malaysian Government Updates Requirements for Exempt Devices July 27, 2017 Importers or manufacturers of these devices are exempted from the establishment license requirement. Read More
FDA Cites OsteoSymbionics for Procedural Failures July 27, 2017 The FDA issued the company a Form 483 after a March inspection of its Cleveland facility. Read More
EMA Issues Final Opinion Limiting Gadolinium Contrast Agents in Body Scans July 27, 2017 The intravenous linear products gadodiamide, gadopentetic acid and gadoversetamide should be suspended in the EU, the agency said. Read More
Tyson Bioresearch Lands 483 for Procedural Problems July 25, 2017 The firm’s handling of complaints also contravened its standard operating procedures. Read More
FDA Cites Neurotron for Instructions, Calibration Issues July 25, 2017 The agency also faulted the device manufacturer for calibration procedures. Read More
FDA Clears DarioHealth’s Glucose Meter and App July 25, 2017 The pocket-sized meter device syncs with a companion app, available on Android and iOS devices, which includes a nutrition guide and log. Read More
Most Device Trials Still Ignore Age, Sex, Race July 25, 2017 Of 82 studies filed in 2015, only 9 percent were analyzed by age and 4 percent by race. Read More
Biowave Hit With Form 483 Over Quality Audits, Management Review July 24, 2017 Investigators found that the facility lacked management review procedures. Read More
FDA Cites Mb Industria Cirurgica on CAPA, Training July 24, 2017 The agency issued the form following a March inspection of the firm’s facility in Paulista, Brazil. Read More
Masimo Scores CE Mark for RPVi Device July 24, 2017 The announcement comes the week after the company announced CE Mark approval for its Rainbow Super DCI-mini sensor. Read More
FDA Announces Recall for Penumbra Revascularization Device July 24, 2017 The device is indicated for revascularization of patients with acute ischemic stroke. Read More