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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
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
The FDA in February 2022 published its long-awaited proposed rule to officially harmonize its Quality System Regulation (QSR) for medical device manufacturers with ISO 13485, the international standard for quality management systems. The agency had first announced its intention to update the QSR in May 2018. 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
Conmed is expanding its implant portfolio with the purchase of Biorez, a Connecticut-based start-up that focuses on soft tissue healing technology. Read More
Once all of a violative product has been removed from the market and all corrective and preventive actions (CAPAs) have been completed, a company can expect a formal end to a recall. Termination of a recall occurs once the FDA determines that a manufacturer has made all reasonable efforts to remove or correct the faulty product in accordance with the recall strategy and that it is reasonable to assume that the product has been removed and proper disposition or correction has been made commensurate with the degree of hazard posed by the product. Read More