eCential Robotics announced today that it received FDA 510(k) clearance for its spine navigation and robotic-assistance device.

Siemens Healthineers‘ Varian announced today that it received FDA 510(k) clearance for a new functionality for its Ethos therapy system.

The South Korean company’s Epysqli is now FDA-approved for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome in the U.S., having grabbed the lead in the Soliris biosimilar market in Europe.

Umbrella brand will offer pelvic health products including Amielle Comfort directly to consumers.