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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.
Bethesda, Md.-based RightEye, manufacturer of the RightEye Vision System, has received a warning letter from the FDA for marketing its device without a premarket approval application for new indications, failure to maintain written design control procedures and other serious lapses.
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.
Diabetics using LifeScan’s Bluetooth-connected blood glucose monitor (BGM) in conjunction with a diabetes management digital app experienced better blood sugar control, lowered hyperglycemic readings, and significantly reduced mean glucose, the company reported in the Journal of Diabetes and Technology. Read More
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.”