The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS posts request for information for Lyme diagnostics; NICE: Stak device backed by one 35-enrollee study.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA posts advisory for respiratory splitters; NICE: Propel device not ready for routine use; MITA sounds off on third parties with white paper; Ethicon, AIM settle on Esutures sales.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: EMA initiates OPEN collaboration; NICE evaluating guidance processes; Florida researcher indicted.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CEO tells patients their deaths were impending for profit; DeGette, Bucshon ink new testing legislation; NICE: Acupath’s URO17 test needs more data.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CDC reports on cases, sequencing; NICE says savings seen with Cytosorb; IP at issue as WTO pushes for global pandemic effort; Researcher gets prison time for trade secret theft; USPTO responds to COVID-19 challenge.
LONDON – The U.K. National Institute for Health and Care Excellence (NICE) has published new advice on how and when artificial intelligence (AI) could be applied to the interpretation of mammograms and chest computer tomography images, in a move that is intended to set the ground rules for the uptake of these technologies. In population breast screening, NICE looked at how five AI systems could be used to pick out mammography images that need further assessment, supporting qualified radiologists in their interpretation.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: New test beats biopsy for transplant rejection; NICE eyes digital health HTAs; MHRA moves on the hazards of bedrails; TGA zeroes in on tests for COVID-19; HHS posts rule for agency enforcement action.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA grants EUA to Quanterix for Simoa test; EC investing in startups; Alternatives to animal testing a challenge; USPTO seeks more uniformity between PTAB, courts; NICE nods to Olympus Plasma for BPH.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: USTR seeking input on nations with poor IP protections; NICE sticks with ABI to evaluate PAD; Health Canada to extend COVID-19 flexibilities.
LONDON – After a year in the mill, the U.K. National Institute for Health and Care Excellence (NICE) has put proposals for how it intends to evaluate drugs, devices and diagnostics in the future out for consultation.
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