MedTech News
eCential Robotics wins FDA clearance for spine navigation robot developed in J&J collab
eCential Robotics announced today that it received FDA 510(k) clearance for its spine navigation and robotic-assistance device.
Varian wins FDA nod for new Ethos radiotherapy offering
Siemens Healthineers‘ Varian announced today that it received FDA 510(k) clearance for a new functionality for its Ethos therapy system.
Samsung Bioepis Gets FDA Approval for Biosimilar to AstraZeneca’s Soliris
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.
Owen Mumford launches pelvic health brand Clariti
Umbrella brand will offer pelvic health products including Amielle Comfort directly to consumers.
Study shows promise for a universal influenza vaccine: Scientists validate theory using 1918 flu virus
New research led by Oregon Health & Science University reveals a promising approach to developing a universal influenza vaccine—a so-called “one and done” vaccine that confers lifetime immunity against an evolving virus.
Anaconda Biomed receives IDE approval for enrollment in ATHENA study
Anaconda Biomed S.L., a medical technology company developing next-generation thrombectomy systems, has announced that it has received conditional IDE approval from the U.S. Food and Drug Administration to begin the ATHENA study of its ANA Funnel Catheter.
EKF Diagnostics launches Biosen C-Line glucose and Lactate analyser
EKF Diagnostics Holdings, the AIM-listed global diagnostics business, has announced the launch of its new Biosen C-Line (Biosen), an advanced version of its industry leading rapid benchtop glucose and lactate analyser.
Inspire sleep apnea therapy wins CE mark under the MDR
Inspire Medical Systems (NYSE: INSP)+ announced today that its Inspire therapy has secured its CE mark under the EU’s Medical Device Regulation.