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Device developers and other stakeholders are encouraged to include both on-site and virtual site proposals and to address patient engagement as a supplemental topic.
Manufacturers can now submit proposals to participate in the Center for Devices and Radiological Health’s (CDRH’s) Experiential Learning Program (ELP), an on-site or virtual visit program that gives CDRH staff an opportunity to better understand the device development life cycle.
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.