In Brief: Cryomedical Sciences
This article was originally published in The Gray Sheet
Cryomedical Sciences: Gains 510(k) clearance for its CMS Urethral Warmer System, an accessory to its AccuProbe cryosurgical system. After an original determination that the warmer needed review via premarket approval application, FDA allowed Rockville, Maryland-based CMS to submit a 510(k) for the device in early 1994, provided that the company met certain conditions including submission of clinical data ("The Gray Sheet" Feb. 14, 1994, In Brief)...
You may also be interested in...
The European public assessment report for Kaftrio shows that EU regulators had concerns about whether Vertex’s triple drug combination for cystic fibrosis represented a new treatment paradigm.
Swissmedic says its good manufacturing practice certificates remain valid for longer than companies might assume. Separately, it is giving companies more time to conduct nitrosamine-related risk evaluations.
Stada has appointed a head of digital communications; PGEU elects new chair and vice-chair; and the new UK health claims committee unveils its first members.