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Currently, “there is no clinically accepted method of continuous beat-to-beat blood pressure monitoring that patients can use outside of the hospital setting,” said the consortium’s leader.
San Antonio, Texas-based ErgoMed received a Form 483 after an FDA inspection found a lack of supplier and product controls as well as repeated quality lapses.
The FDA’s de novo program is the best pathway to market authorization for devicemakers developing a unique product that has “no substantial equivalent” (NSE) device already cleared by the agency.
RefleXion Medical’s SCINTIX, a biology-guided radiotherapy that turns cancer cells into “biological beacons” that control radiotherapy delivery to tumors, has received de novo marketing authorization from the FDA to treat lung and bone tumors.
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.