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Home » Topics » Regulatory » NICE

NICE
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Regulatory front for Jan. 13, 2021

Jan. 13, 2021
By Mark McCarty
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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Regulatory front for Jan. 6, 2021

Jan. 6, 2021
By Mark McCarty
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.
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Regulatory front

Klobuchar worried about data security for Amazon Halo

Dec. 14, 2020
By Mark McCarty
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.
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NICE reviews how it evaluates drugs, devices and diagnostics

Nov. 6, 2020
By Nuala Moran
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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Regulatory front

PTO sees spike in patent applications reciting AI

Nov. 6, 2020
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NICE reviews Dexcom’s G6; Ortho claims EUA for antigen test with 100% sensitivity.
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U.K. flag on stethoscope

NICE seeks input on changes to topic selection process

Nov. 4, 2020
By Nuala Moran
LONDON – The U.K.’s influential health technology assessment body, the National Institute of Health and Care Excellence (NICE), is consulting stakeholders on proposed changes to how it selects medical devices, diagnostics and drugs for evaluation.
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Digital 3d heart model showing FFR values along coronary arteries
TCT Connect 2020

FFR processing fails to blunt costs in U.K. study of patients with stable angina

Oct. 16, 2020
By Mark McCarty
Fractional flow reserve (FFR) processing of computed tomography (CT) images has gained a substantial body of momentum over the past few years, but a recent study posed the question of whether it can save health care systems from excess spending for stable angina.
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