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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.
The device makes it “possible to uncover elevated risk for these complications earlier and more accurately than traditional clinical approaches,” the company said.
Diabetes nonprofit organization Tidepool has received FDA clearance for its crowd-sourced Tidepool Loop, the first automated insulin dosing app that works from an Apple Watch.