Megadyne recalls and removes from the market all Mega Soft Pediatric Patient Return Electrodes after receiving reports of patient burn injuries.
FDA gives SN Bioscience a fast-track designation for its nanoparticle anticancer drug SNB-101 for treating small cell lung cancer.
Route 92 Medical recalls (Class 1) several lots of its products containing the Tenzing 7 Delivery Catheters due to multiple instances of distal tip se...
FDA grants Novartis a breakthrough therapy designation for Scemblix (asciminib) for treating adult patients with newly diagnosed Philadelphia chromoso...
FDA publishes a final guidance to clarify the distinctions between medical device remanufacturing and servicing.
A BMJ investigation looks at the relationship between several FDA commissioners and the companies the agency regulates.
FDA says Exocel Bio in San Diego is marketing unapproved exosome products.
Vyaire Medical recalls (Class 1) its Vyaire Twin Tube sample line 240 cm, Model Number V-707327, which is used in the companys Vyntus CPX cardiopulmon...