The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Rep. Payne resurrects colorectal cancer screening bill; Former Practice Fusion employee enters guilty plea; NICE says Alpha-Stim not ready for anxiety disorder.
LONDON – The National Health Service (NHS) in the U.K. has agreed to reimburse Zolgensma, the one-off gene therapy treatment for spinal muscular atrophy billed as the most expensive drug in the world, after a confidential deal was struck with Novartis Gene Therapies.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: AHRQ: Patient portals underused in ED visits; Butterfly IQ scores well on cost, but supporting data limited.
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.
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