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.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NICE unimpressed by stenosis measurement software; MedPAC says more study needed for expanded telehealth coverage.
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.
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