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Proov — a Colorado-based diagnostics company that makes the only FDA-cleared urine progesterone (PdG) test — has received a fourth patent for its at-home multi-hormone test for predicting ovulation.
The FDA has updated Medtronic’s November 2022 recall of its Mahurkar Acute Dual Lumen High Flow (13.5 French) hemodialysis catheters to Class I, due to a potential catheter hub defect that could cause the catheter tubes to leak, possibly leading to serious injury or death.
The FDA is planning to survey medical devicemakers and other “key stakeholders” to identify barriers that prevent developers from entering the pediatric device market as well as “incentives that would motivate them to innovate and sustain within this market.”
The FDA has invited devicemakers to apply for funding to develop medical devices for children through the FDA’s Pediatric Device Consortia grants program.
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.
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.