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Devicemakers still using a paper-based quality management system (QMS) should seriously consider adopting an electronic QMS, advised compliance expert Sundeep Agarwal, in a recent FDAnews webinar.
In a postmarket study, IRRAS’s IRRAflow fluid exchange system more effectively removed blood from chronic subdural hematomas (cSDH) and reduced catheter-related infections when compared to passive drainage alone, researchers reported in the journal Operative Neurosurgery.
The FDA highlighted the need for long-term neurodevelopmental studies by sponsors of neonatal medical products —whether a drug, biologic product or device — in a new draft guidance released Friday.
The FDA has issued a warning letter to Nendingen, Germany-based laparoscopy devicemaker Getsch+Hiller Medizintechnik (GH) for unapproved product changes, the lack of a design history file and other lapses observed during a July 2022 inspection.
GE Healthcare is acquiring Caption Health, a California-based company that uses artificial intelligence (AI) solutions for early detection of heart disease in ultrasound scans.