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Modulight’s ML6710i photodynamic laser for use with Bauch + Lomb’s Visudyne (verteporfin) for the treatment of age-related macular degeneration (AMD) may help fill an unmet medical need, the companies said.
Penn Medicine cancer center in Philadelphia has performed the first ever patient treatment with Varian’s Halcyon and Ethos radiotherapy systems using the company’s HyperSight imaging technology.
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.