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BioWorld - Tuesday, April 7, 2026
Home » Topics » Regulatory » NICE

NICE
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UK’s NICE says hybrid closed-loop CGMs are primed for type 1 diabetes

Nov. 9, 2023
By Mark McCarty
The U.K. National Institute for Health and Care Excellence (NICE) has seen the nation’s spending numbers for diabetes, which is said to account for roughly 10% of healthcare spending in the U.K., and responded in a collaboration with the National Health Service (NHS).
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NICE says cryotherapy for chronic rhinitis not ready for prime time

Sep. 18, 2023
By Mark McCarty

Chronic rhinitis is drawing more attention from medical device makers in recent years, with solutions including cryotherapy and temperature-controlled radiofrequency disruption of posterior nasal nerves to halt the condition.


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Device in heart

UK’s NICE wary of routine use of Ozaki procedure for aortic valve reconstruction

Aug. 14, 2023
By Mark McCarty
Transcatheter aortic valve replacement (TAVR) devices are all the rage for treatment of aortic valve disease, but that doesn’t mean valve reconstruction via the so-called Ozaki procedure has been consigned to the pages of medical history. The U.K.’s National Institute for Health and Care Excellence has recommended that trusts in the U.K. health system use this procedure only in clinical trials at least for the time being, although the agency noted that the Ozaki procedure allows the patient to sidestep the need for long-term antithrombotic therapy, a big selling point for patients and clinicians alike.
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Alpha-Stim AID device

Alpha-Stim AID finally offered to patients in the UK with anxiety

July 7, 2023
By Shani Alexander
Electromedical Products International Inc. (EPI) Alpha-Stim AID technology is finally being made available by the NHS in the U.K. to treat patients with anxiety some two years after the National Institute for Health and Care Excellence (NICE) said there was not enough good-quality evidence to support the case for routine adoption.
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UK’s NICE says AI-assisted detection of lung nodules not ready for prime time

July 5, 2023
By Mark McCarty
The U.K. National Institute for Health and Care Excellence (NICE) released several draft and final health technology assessments on July 5, including a review of the use of artificial intelligence (AI) to aid in the detection of lung nodules in CT images. The agency said that more research is needed before it will be able to provide an unqualified endorsement because of a relative lack of data that could be reliably generalized from clinical study subjects to the broader U.K. population at large.
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United Kingdom flag, map

NICE eyes revamp of med-tech evaluation process

June 27, 2023
By Mark McCarty
The U.K. National Institute for Health and Care Excellence (NICE) has undertaken a public consultation for a series of proposed changes to its procedures for evaluating medical devices and other medical technologies that could speed up these reviews. This new process would require a less time-consuming approach to evaluating lower-risk technologies that would not only turn around such evaluations more rapidly but would also leave more resources available for higher-risk products that would also enjoy a timelier review, thus potentially accelerating adoption of all these products in the National Health System.
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Radiotherapy of cancer

UK’s NICE says radiotherapy dosing can be decreased for some breast cancers

June 20, 2023
By Mark McCarty
Radiotherapy fractionation has had a significant impact on the morbidity associated with the procedure across a number of cancer types, and the U.K. National Institute for Health and Care Excellence (NICE) says it may be time to fractionate further for some breast cancer patients.
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Prostate cancer cells

NICE sees evidence gaps for MRI-ultrasound fusion prostate biopsy systems

May 31, 2023
By Mark McCarty
In a new health technology assessment, the U.K. National Institute for Health and Care Excellence (NICE) has voiced misgivings about the evidence behind the use of MRI/ultrasound fusion systems to perform needle biopsy for suspected prostate cancer. NICE said the evidence for these systems could be bolstered by additional research comparing fusion biopsy to cognitive fusion-directed biopsy, suggesting that companies working in this space have a significant evidentiary lift in front of them.
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U.K. flag on stethoscope

Reports says UK government needs to speed up approval of med-tech devices

May 30, 2023
By Shani Alexander
The U.K. government should speed up the approval process for medical devices and strengthen the Medicines and Healthcare products Regulatory Agency, as there is an opportunity for the country to provide global leadership in life sciences regulation in medical devices and medicines on the back of Brexit, according to a report.
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UK map and pharmaceuticals

NICE says no to five COVID-19 treatments in the UK

Nov. 16, 2022
By Lee Landenberger
Britain’s National Institute for Health and Care Excellence (NICE), a key gatekeeper on the path to the U.K. market, is backing away from five COVID-19 treatments. No longer recommended in a draft guidance were Ronapreve (casirivimab + imdevimab) from Roche Holding AG, Xevudy (sotrovimab) from GSK plc, and Evusheld (tixagevimab + cilgavimab) from Astrazeneca plc. NICE also recommended discontinuing use of Lagevrio (molnupiravir) from Merck and Co. Inc. and Veklury (remdesivir) from Gilead Sciences Inc.
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