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BioWorld - Saturday, April 11, 2026
Home » Topics » Regulatory » NICE

NICE
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3D rendering showing osteoporosis in the femur

NICE nods to AI in detection of osteoporosis-driven vertebral fracture

Oct. 22, 2025
By Mark McCarty
Vertebral compression fractures are one of the more obvious signs of osteoporosis but can be difficult to diagnose, one of several reasons the U.K. National Institute for Health and Care Excellence has given the nod to five AI products that can improve rapid detection of these fractures.
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U.K. flag on stethoscope

UK’s NICE seeks to streamline workflow to improve access

Sep. 29, 2025
By Mark McCarty
The U.K. National Institute for Health and Care Excellence unveiled a plan that is designed to provide less cumbersome market access for medical technologies.
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Device in heart

NICE tells docs to pay less for TAVR when possible

Aug. 22, 2025
By Mark McCarty
The U.K. National Institute for Health and Care Excellence has recommended that physicians in the U.K. use the least expensive, clinically appropriate TAVR device when possible, concluding a pricing review that commenced roughly a year ago.
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3D illustration of knee joint

NICE says multidisciplinary team needed for knee cartilage patient selection

Aug. 5, 2025
By Mark McCarty
The U.K. National Institute for Health and Care Excellence updated its guidance for the use of single-procedure insertion of scaffolds for knee cartilage repairs, specifying that only qualified surgeons should perform the procedure.
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MHRA logo

MHRA eyes expanded reliance programs to boost patient access

July 22, 2025
By Mark McCarty
The U.K. Medicines and Healthcare Products Regulatory Agency unveiled another round of measures designed to promote access to the latest medical technology, which includes a move to jettison domestic device markings in favor of unique device identifiers.
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United Kingdom flag, map

Life sciences strategy to reduce UK approval costs by 25%

July 17, 2025
By Nuala Moran
No Comments
The U.K. government has committed to reduce the cost of drug and device approvals by 25% as part of a long-awaited life sciences strategy which sets out a 10-year plan for the sector.
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Atrial fibrillation illustration

NICE endorses pulsed field ablation for atrial fibrillation

July 16, 2025
By Mark McCarty
The U.K. National Institute for Health and Care Excellence (NICE) has endorsed the use of pulsed field ablation for atrial fibrillation, and while several trusts in the U.K. are already using these devices for their patients, the endorsement is certain to expand utilization in the U.K., which according to data from Clarivate’s Epidemiology Intelligence may come to nearly 4 million.
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United Kingdom flag, map

Life sciences strategy to reduce UK approval costs by 25%

July 16, 2025
By Nuala Moran
No Comments
The U.K. government has committed to reduce the cost of drug and device approvals by 25% as part of a long-awaited life sciences strategy which sets out a 10-year plan for the sector.
Read More
Illustration of TAVR device

NICE still wary of TAVR in moderate and low risk patients

June 27, 2025
By Mark McCarty
The U.K. National Health Service may or may not deploy transcatheter aortic valve replacement devices as widely as in the U.S., but the National Institute for Health and Care Excellence officially staked out the position the data are not yet compelling for anyone other than high risk patients.
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Brain, syringe hovering over hands

NICE rejects Lilly‘s Kisunla and Eisai‘s Leqembi

June 20, 2025
By Nuala Moran
No Comments
To no great surprise, the U.K.’s health technology assessment body has found that the benefits of the first two approved Alzheimer’s disease drugs are too small to justify the costs. Neither Kisunla (donanemab, Eli Lilly and Co. Inc.) or Leqembi (lecanemab, Eisai Co. Ltd.), “demonstrate sufficient benefit to justify their high cost, including the cost of administering them,” the National Institute of Health and Care Excellence (NICE) concluded after an extended appraisal of the two amyloid neutralizing antibodies.
Read More
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