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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.
Gastrointestinal diagnostic test developer Geneoscopy has submitted a premarket approval (PMA) application to the FDA for its ColonoSight, a stool-based at-home noninvasive screening test that detects colorectal cancer (CRC) and advanced adenomas (AA) in average-risk individuals.