Med Tech-related technology assessments and clinical guidelines from NICE in September 2020

In September, NICE published one new interventional procedures guidance for transcranial magnetic stimulation for auditory hallucinations.

Interventional Procedure Guidance 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.

Evidence on the safety of transcranial magnetic stimulation for auditory hallucinations is adequate and raises no major safety concerns. However, evidence of its efficacy is inadequate in quantity and quality. Therefore, this procedure should only be used in the context of research.

Medical technologies guidance evaluates new, innovative medical devices and diagnostics. It looks at medical technologies that deliver treatment, like those implanted during surgical procedures, give greater independence to patients or detect or monitor medical conditions.

In September, NICE issued one new medical technologies guidance on Axonics sacral neuromodulation system for treating refractory overactive bladder. NICE concluded that evidence supports adopting the Axonics SNM system, as it improves symptoms and quality of life, and should be considered as an option when conservative or pharmacological treatment has not worked. Cost modeling estimates that over 15 years, the Axonics SNM system is cost-saving compared with the non-rechargeable system by about £6,025 per person.

MedTech Innovation Briefing is the NICE's advice program 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.

Four MedTech Innovation Briefings were published in September:

• Novii Wireless Patch System for maternal and fetal monitoring - fetal and maternal monitor used to measure the heart rates of fetus and mother, and the activity of the uterus
• t:slim X2 insulin pump for managing blood glucose levels in type 1 diabetes – for continuous subcutaneous insulin delivery
• Synergo for non-muscle-invasive bladder cancer - treatment is based on controlled radiofrequency radiation (non-ionising microwave radiation) of the bladder tissue, along with instillations of the bladder with chemotherapy (thermo-chemotherapy)
• Helge for detecting haemolysis – point-of-care technology that can test blood samples for haemolysis without the need for centrifugation

In September 2020, NICE evaluated implantable cardiac monitors detecting atrial fibrillation after cryptogenic stroke (BioMonitor 2-AF, BioMonitor III, Confirm Rx, and Reveal LINQ) in the diagnostic guidance program. NICE recommended Reveal LINQ as an option to help to detect atrial fibrillation after cryptogenic stroke, including transient ischaemic attacks, only if non-invasive electrocardiogram monitoring has been done and an arrhythmic cardiac cause of stroke is still suspected. Clinicians should consider if disabled people may need support from a carer to help set up the MyCareLink Patient Monitor to ensure data from Reveal LINQ are transmitted for review. NICE concluded that there is not enough evidence to recommend the routine adoption of BioMonitor 2‑AF (or its successor device BioMonitor III) or Confirm Rx to detect atrial fibrillation after cryptogenic stroke. Further research is recommended to assess the diagnostic yield (a measure of how many people with atrial fibrillation are diagnosed) of these devices for atrial fibrillation when used in people who have had a cryptogenic stroke.

Also, three clinical guidance were updated in September:

• Low back pain and sciatica in over 16s: assessment and management
• Suspected cancer: recognition and referral
• Neuropathic pain in adults: pharmacological management in non-specialist settings

See the full details here.

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