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Home » Topics » Regulatory » NICE

NICE
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Reducer device

Neovasc touts NICE health tech assessment as a win

Nov. 24, 2021
By Mark McCarty
The U.K. National Institute of Health and Care Excellence (NICE) issued two health technology assessments dated Nov. 24, including one that gives a guarded recommendation for devices used to narrow the coronary sinus as a treatment for refractory angina. Neovasc Inc., of Richmond, British Columbia, touted the news as a positive for its Reducer device, given that this is the first instance in which NICE has lent any support for a device to treat the condition.
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Boston Sci scores win with Enduralife battery tech for CRDs

Nov. 8, 2021
By Mark McCarty
The U.K. National Institute for Health and Care Excellence said in a new health technology assessment that cardiac resynchronization devices using the Enduralife battery by Boston Scientific Corp. (BSX), are ready for prime time in the U.K. national health system.
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U.K. flag on stethoscope

NICE says mitral valve-in-valve procedures not ready for routine utilization

Sep. 22, 2021
By Mark McCarty
The U.K. National Institute of Health and Care Excellence (NICE) has examined the evidence for the use of mitral valve-in-valve procedures and found the evidence for safety is well rounded despite concerns about several complications.
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Hand holding vial of Magtrace

Endomag receives NICE endorsement for Magtrace cancer staging technology

Aug. 25, 2021
By Nuala Moran
LONDON – Endomag Ltd. has received endorsement from the U.K. health technology assessment body NICE, opening the way to broader adoption of its Magtrace non-radioactive cancer staging technology in the National Health Service, and providing backing for commercialization of the system in other markets.
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U.K. flag and capsules

NICE announces first quick funding okay as it plays catch-up after COVID-19

Aug. 4, 2021
By Richard Staines
The U.K.’s National Institute for Health and Care Excellence (NICE) is playing catch-up after seeing its workflow disrupted by the COVID-19 pandemic and has made the first funding approval using a new fast track appraisal process.
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Pill with British pound sign

NHS England tackles pricey gene therapies with £340M fund

July 23, 2021
By Richard Staines
NHS England has announced a new £340 million (US$481 million) Innovative Medicines Fund, as the country grapples with the issue of bringing ultra-pricey specialist medicines to patients on the country’s taxpayer-funded health care system.
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NICE recommends paravalvular leak treatment be handled in studies

July 20, 2021
By Mark McCarty
The U.K. National Institute for Health and Care Excellence (NICE) said devices used to repair paravalvular leak around replaced mitral or aortic valves should only be used in studies because of a limited set of data on efficacy.
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NICE rejects Orchard’s rare disease drug, but Zolgensma U-turn offers hope

July 9, 2021
By Richard Staines
NICE has said “no” to regular NHS funding for a rare disease gene therapy from Orchard Therapeutics Ltd. in draft guidance – although experience from Novartis AG’s pricey Zolgensma (onasemnogene abeparvovec) for spinal muscular atrophy shows this could change. That’s because this week NICE published final guidance that recommends funding for Zolgensma, thought to be the world’s most expensive drug, after an initial rejection late last year.
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Artificial intelligence and digital health icons

UK launches advice service for AI developers, users

June 23, 2021
By Nuala Moran
LONDON – The U.K. is setting up a service for developers and users of artificial intelligence (AI) to provide a single source of advice covering all requirements for the technology, from clinical research to regulatory scrutiny, health technology evaluation and through to commissioning.
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Fallopian tubes, ovaries and uterus

UK’s NICE: Transvaginal laser therapy for stress incontinence, vaginal atrophy may not be safe or effective

June 7, 2021
By Nuala Moran
LONDON – The U.K. health technology assessment agency, NICE, has called for a halt to the use of transvaginal laser therapy in the treatment of urinary stress incontinence and vaginal atrophy, saying there is not enough evidence of long-term safety, or proof that the procedures are effective.
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