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MedTech-related technology assessments and clinical guidelines from NICE in January 2023
In January 2023, four new Interventional Procedures Guidance were published by NICE. Interventional Procedures Guidance (IPG) is developed for most of the novel interventional procedures entering the English market. The program focuses solely on clinical evidence. Recommendations may vary from "for research only" to "for use with standard arrangements for clinical governance, consent, and audit." Recommendations are not binding, although they are followed by providers and commissioners.
For the following procedures, NICE concluded that evidence on the safety and efficacy is adequate to support using them with standard arrangements for clinical governance, consent, and audit:
- Laparoscopic insertion of a magnetic ring for gastro-oesophageal reflux disease;
- Trabeculectomy with a biodegradable collagen matrix implant for glaucoma.
For the following procedures, NICE concluded that evidence on the safety and efficacy is inadequate in quality and quantity, and they should only be used in the context of research:
- Transcutaneous electrical stimulation of the trigeminal nerve for ADHD;
- Percutaneous image-guided cryoablation of peripheral neuroma for chronic pain.
In January 2023, two new Diagnostic Guidance were published by NICE. The Diagnostic Guidance (DG) program focuses on evaluating innovative medical diagnostic technologies to ensure that the NHS can adopt clinically and cost-effective technologies rapidly and consistently.
NICE assessed devices for remote monitoring of Parkinson’s disease, and conditionally recommended Kinesia 360, KinesiaU, PDMonitor, Personal KinetiGraph (PKG) and STAT‑ON as options to inform treatment only if further evidence is generated and cost impact is managed.
NICE concluded that there is not enough evidence to recommend MRI-based technologies for assessing non-alcoholic fatty liver disease (LiverMultiScan and magnetic resonance elastography, MRE) in people with indeterminate or discordant results from previous fibrosis testing or when transient elastography or acoustic radiation force impulse (ARFI) elastography is unsuitable or has not worked.
The MedTech Innovation Briefings (MIBs) is the advice program of NICE for innovative technologies. It provides an overview of clinical effectiveness, safety, and cost. It does not offer formal guidance, and it, therefore, does not provide any recommendations. The three new MIBs published in January 2023 are:
- PredictSURE IBD for inflammatory bowel disease prognosis: ulcerative colitis. This blood test uses RT-PCR to measure the expression of 17 genes, and a specific algorithm produces a clinical outcome prediction (high or low risk) for severe, relapsing inflammation of ulcerative colitis.
- Ambu aScope 4 Broncho for routine diagnostic and therapeutic bronchoscopy. This single-use bronchoscope potentially reduces the risk of cross-infection and eliminates the need for complex reprocessing of reusable endoscopes;
- Aquablation robotic therapy for lower urinary tract symptoms caused by benign prostatic hyperplasia. Resection and removal of prostate tissue are done with transurethral water jet ablation using the robotic handpiece placed within the urethra.
One MedTech-related clinical guideline on hip fracture management was updated in January 2023:
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