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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
The FDA needs to clarify its draft regulatory framework for 3D printing at the point of care (3DPOC), according to a new analysis from the Pew Charitable Trusts. Read More
The reagent kit is intended for use with the company’s soluble FMS-like tyrosine kinase-1 (sFlt-1) reagent kit for detecting the sFlt-1 protein in maternal serum. Read More
Establishing operational limits is a key issue to consider. These are the limits that are obtained during the operational qualification (OQ) testing over the expected operating range. So for instance, this applies to equipment and cleaning practices over the expected range, the history or the variety of products that you’re running. Read More