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.
The FDA has invited devicemakers to apply for funding to develop medical devices for children through the FDA’s Pediatric Device Consortia grants program.
Insulet announced that it has emailed 29,000 Omnipod insulin pump customers to advise them that some of their personal health information (PHI) — but not financial, social security number, email or password — was inadvertently shared with Insulet’s website performance and marketing partners.
Stroke-specific machine learning algorithms were no better at predicting stroke risk than self-reported risk factors and were worse in predicting stroke risk in Black patients than in White patients, according to a new study published in JAMA Network.
The Jan. 25 issue of Device Daily Bulletin incorrectly characterized the reason for Medtronic’s recall of HeartWare Ventricular Assist Device batteries. The company has recalled the batteries to examine them for a potential weld defect.
A new study published in the journal BMJ Open Ophthalmology shows that an artificial intelligence algorithm can successfully predict the future development of diabetic retinopathy (DR) in patients without current diagnosable symptoms. Read More
The FDA has posted the latest analytics on its Global Unique Device Identification Database (GUDID), reporting a significant increase in the number of submissions as of Jan. 10.
The FDA issued updates on recalls of Datascope/Getinge’s Cardiosave Hybrid and Rescue intra-aortic balloon pumps (IABP) and certain Emergent reactive skin decontamination lotion (RSDL) kits, declaring them to be Class 1 recalls because of the “reasonable probability” that use of the devices could cause serious harm or death.