In Brief: Trimedyne
This article was originally published in The Gray Sheet
Executive SummaryTrimedyne: OmniPulse holmium laser and "related disposable fiber optic devices for all soft tissue applications in ear, nose and throat surgery" gains marketing clearance from FDA the firm says. The expanded applications include tonsillectomy and uvula and soft palate surgery, and complement the laser's previous clearance for sinus surgery, according to Trimedyne...
You may also be interested in...
US investigators fan out to non-China inspection priorities and Secretary Azar talks supply management; warning letters hit record keeping, investigations and basic GMP compliance.
Mallinckrodt to pay $1.6bn and place its generics unit in bankruptcy under agreement in principle for US global settlement; six states are not on board, including New York, whose suit is still set to go to trial March 20.
The company has reached a broad opioid settlement agreement in principle under which its specialty generics subsidiaries would file for Chapter 11 bankruptcy and Mallinckrodt's branded business would operate separately.