Device reprocessing has intermittently prompted FDA action in an effort to tamp down on infection-driven adverse events for various types of endoscopes, and the latest spate of events involves endoscopes used in urological applications. While the three associated fatalities all took place outside the U.S., the FDA nonetheless indicated that it is considering the possibility that a device redesign is in order, a move the agency endorsed in connection with infections blamed on duodenoscopes.
Vysioneer Inc. has won the FDA’s nod for its Vbrain artificial intelligence (AI)-powered tumor autocontouring software. The company said Vbrain is the first AI device to receive FDA clearance for tumor autocontouring in radiation therapy. Vbrain is a neural network-based AI solution, trained from clinical data.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA adds fingerstick sample to roster of COVID EUAs; NICE: Sonata system not backed by head-to-head studies.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Philips, Roche.
Nearly 16,500 groups and individuals put in their two cents on a proposed National Institute of Standards and Technology (NIST) rule clarifying that the U.S. government, under the Bayh-Dole Act, can’t march in on patents derived from federally funded research just because it doesn’t consider the price of the resulting product “reasonable.”
The European Commission opened a public consultation to help it develop the Health Emergency Preparedness and Response Authority, a new initiative to better prepare Europe for cross-border health threats.
The FDA has granted 510(k) clearance to Orthofix Medical Inc.’s Construx Mini Ti spacer system for anterior cervical discectomy and fusion (ACDF) procedures. Company documents claim the implant has an optimized porosity and pore size, which creates a 3D porous surface with the potential for bone ingrowth.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: COVID-19 inventions included in USPTO awards program; First thrombosis incident reported in Australia; FDA revises Moderna EUA; GAO refuses to reconsider VA challenge.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Electrocore, Orthofix, Surgical Information Sciences, Vysioneer.
CAJICA, Colombia – The tiny Central American country of Costa Rica continues to cement its position as Latin America’s med-tech powerhouse after experiencing double-digit growth in exports in the first two months of the year, according to data released by Procomer, the country's exports promotion agency. “These numbers become more relevant when detailing that medical devices and precision equipment represent, for the third consecutive year, the country's main export, which had double-digit growth of 23%, thus representing 36% of the exports of the country,” the Costa Rican government said.
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