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Regulatory front for April 20, 2021

April 20, 2021
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA provides path for diagnostic testing using pooled samples; FDA inks warnings for pandemic testing; Recall issued for repaired infusion pumps; NICE launches transformative strategy; NICE launches transformative strategy; Russia expands access to certain pediatric treatments.
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Regulatory front for April 13, 2021

April 13, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NICE needs more evidence for Clarity RMS for AKI; Thermacor disposable sets recalled.
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Regulatory front for April 9, 2021

April 9, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS, DOJ officials highlight pandemic response needs; FDA says plenty of respirators available; NICE supports use of Danis for variceal hemorrhage.
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Regulatory front for April 8, 2021

April 8, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FCC says no need to revisit telehealth grants; NICE updates sphere usage for hepatocellular carcinoma; Health Canada: Docs, nurses not needed for workplace testing.
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Regulatory front for April 7, 2021

April 7, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA hits company for deviations from drug, device GMPs; Stryker undertakes correction for AEDs; MHRA: Creams, ointments may interfere with CGM function; NICE says liver perfusion suffers for want of evidence of efficacy; NIAID testing vaccine allergy hypothesis; EC provides emergency funding for COVID-19 research; Medtronic splits Ninth Appeals’ review of lower court decision; Industry, docs push back on prior authorization.
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Regulatory front for April 6, 2021

April 6, 2021
By Mark McCarty
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.
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Regulatory front for March 17, 2021

March 17, 2021
By Mark McCarty
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.
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Regulatory front for March 9, 2021

March 9, 2021
By Mark McCarty
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.
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U.K. flag on stethoscope

U.K.’s NHS agrees to reimburse world’s most expensive drug

March 8, 2021
By Nuala Moran
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.
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Regulatory front for March 4, 2021

March 4, 2021
By Mark McCarty
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.
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