We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Insulet has completed two asset purchases that should about double the Massachusetts-based company’s portfolio of pump and automated insulin delivery (AID) technologies.
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studies by sponsors of neonatal medical products —whether a drug, biologic product or device — in a new draft guidance released Friday.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.