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A federal appeals court has ruled that a complaint by a Kentucky woman against the Johnson & Johnson subsidiary Ethicon over two pelvic mesh devices may proceed. Read More
A federal jury in Delaware has awarded Lake Ozark, Mo.-based Osseo Imaging $2.3 million in its patent infringement lawsuit against Planmeca USA for allegedly infringing on three dental and orthopedic imaging patents. Read More
A position paper from the European Commission’s Medical Device Coordination Group (MDCG) proposes a list of actions aimed at easing the burden of notified bodies (NB) under the EU’s new regulations, including use of hybrid audits and evidence from previous assessments. Read More
Nearly 60 percent of patients using Abbott’s Heartmate 3 heart pump are reaching the five-year survival mark, according to results of a postmarket study reported at the 2022 European Society of Cardiology Congress in Barcelona, Spain, Aug. 26-29. Read More
MIT researchers have developed a device that uses artificial intelligence (AI) to detect Parkinson’s disease by monitoring a person’s breathing patterns while they sleep. Read More
LV Liberty Vision lacked proper design validation and verification testing, the FDA said in a Form 483 issued following an inspection of the ophthalmology devicemaker’s Portsmouth, N.H., facility. Read More
Penumbra’s RED reperfusion catheter was effective in removing blood clots in acute eschemic stroke (AIS) patients, according to study data reported at the 2022 World Federation of Interventional and Therapeutic Neuroradiology (WFITN) in Kyoto, Japan, last week. Read More
CellEra has received a Form 483 for not having proper procedures for handling complaints and corrective actions and for other deficiencies observed during an April 11-14 inspection of the company’s Monroe, Ohio, facility. Read More
Question: Does the FDA’s Quality System Regulation (QSR) require a separate maintenance department or can it have production people do the routine maintenance? Read More