We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
As the EU’s 2017 Medical Device Regulation (MDR) comes fully into force, devicemakers need to keep track of significant changes in the form of “implementing and delegated acts,” according to one UK-based regulatory expert. Read More
Smiths Medical has issued an urgent medical device correction letter about a potential risk associated with pressure chambers used with the company’s Level 1 Fast Flow Fluid Warmers, which deliver solutions or warmed blood to patients. Read More
The Center for Devices and Radiological Health (CDRH) is seeking companies involved in medical device development and manufacturing to participate in its Experiential Learning Program (ELP), which sends CDRH staff on virtual or on-site training visits. Read More
Lice Clinics of America says its medical device is the only product on the market that has been cleared by the FDA to use air in treating head lice. Read More
Boston Scientific has agreed to pay $85 million to Nevro to settle their intellectual property litigation over spinal cord stimulation patents. Read More
The FDA has pledged to help manufacturers of sterilized devices if a new emissions regulation planned by the Environmental Protection Agency (EPA) for later this year causes disruption in commercial sterilizer facility operations. Read More
A patent that Magnolia Medical Technologies holds for its Steripath blood specimen diversion device for blood tests is valid, and competitor Kurin owes the company $2.1 million in royalties, according to a federal court verdict. Read More
Sanofi has failed to convince a federal appeals court that Viatris (formerly Mylan) monopolized the market for epinephrine auto-injectors through anticompetitive pricing for its EpiPen. Read More
Device Daily Bulletin Premium takes an in-depth look at the reauthorization of the Medical Device User Fee Act (MDUFA) and how its fifth iteration is taking shape. MDUFA V would reauthorize user fee programs for medical device and diagnostic products from fiscal year 2023 through 2027.Read More
Part of a strong postmarket surveillance system is a good adverse event reporting system. Any company selling an FDA-regulated product of any kind must have an adverse event reporting system in place, including a database designed to manage the collected reports. Read More