Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arecor, Biolabs, Danaher, Edwards, Elekta, Medtronic, Philips, Pulse Biosciences, Reflow Medical, Sam Medical, Samsung Medison, Sonio, Tri-Tech Forensics, Volta Medical, Watmind.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biogennix, Freyja, Othofix, Orthoxel, Terumo.
Right on cue, the U.S. FDA’s Center for Drug Evaluation and Research (CDER) is scheduling its first in-person advisory committee meetings since the COVID-19 pandemic. Speaking during a May 6 webinar hosted by the Alliance for a Stronger FDA, CDER Director Patrizia Cavazzoni said the center was preparing to go back to in-person adcoms, adding that the first step likely would be a hybrid model.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4C Medical, Orthobond, US Medical Innovations.
It’s no surprise to hear that industry’s view of a device’s inherent risk differs from that of the U.S. FDA, a disparity that came to surface in a new citizen petition from Metaltronica SpA of Pomezia, Italy. The company petitioned the agency to down-classify digital breast tomosynthesis system to class II, a move that would align the risk classification with full-field digital mammography and ease the premarket path for future digital breast tomosynthesis applications.
RSS
