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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
The AI software will help more medical professionals to accurately scan patients and improve the detection of cardiovascular diseases, the company said. Read More
Integra LifeSciences has issued a global recall of all its CereLink intracranial pressure (ICP) monitors due to customer reports of pressure readings that were out of range. Read More
Aggredyne drew a Form 483 from the FDA for deficient design change validations and other lapses following an inspection of its Houston, Texas, manufacturing facility from March 29 to April 14. Read More
Campbell, Calif.-based Imperative Care’s Zoom Stroke Solution proved safe and effective in treating distal vessel occlusions in ischemic stroke patients, according to study results presented at the World Federation of Interventional and Therapeutic Neuroradiology’s annual meeting in Tokyo this week. Read More