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Med Tech-related technology assessments and clinical guidelines from NICE in March 2023
In March 2023, NICE published two Interventional Procedures Guidance (IPG):
- Percutaneous transluminal renal sympathetic denervation for resistant hypertension;
- Endoluminal gastroplication for gastro-oesophageal reflux disease.
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.
NICE made the following conclusions:
- Percutaneous transluminal renal sympathetic denervation for resistant hypertension should only be used with special arrangements for clinical governance, consent, and audit or research;
- Evidence on the safety of endoluminal gastroplication for gastro-oesophageal reflux disease is adequate. However, evidence on its efficacy is inadequate in quality, particularly in terms of patient selection and long-term outcomes. Therefore, this procedure should be used only in research.
In March 2023, NICE published three new Health Technology Evaluations (HTE) for medical technologies:
- CaRi-Heart for predicting cardiac risk in suspected coronary artery disease. The technology is a medical imaging analysis software that uses artificial intelligence (AI) to analyze images from CT coronary angiography (CTCA);
- ProKnow cloud-based system for radiotherapy data storage, communication, and management;
- Genedrive MT-RNR1 ID Kit for detecting a genetic variant to guide antibiotic use and prevent hearing loss in babies. The technology is a qualitative in vitro molecular diagnostic test for detecting the MTRNR1 m.1555A>G variant. It is intended to be used by healthcare professionals in a near-patient setting using a buccal swab sample, providing a result within about 26 minutes.
HTE is a new type of NICE guidance that uses a pilot early value assessment (EVA) approach to provide rapid conditional recommendations on promising health technologies that have the potential to address the unmet national need. NICE evaluate the available evidence to determine if earlier patient and system access in the NHS is appropriate while further evidence is generated.
NICE made the following conditional recommendations:
- CaRiHeart is not recommended for use in the NHS while further evidence is generated. It should only be used in research to predict cardiac risk in people with suspected coronary artery disease while treatment strategies to reduce coronary inflammation and cardiac death are identified;
- ProKnow can be used while further evidence is generated. This includes the use of all 3 ProKnow modules: ProKnow DS – a database used for importing, analyzing, and storing patient data; ProKnow CA – a contouring accuracy tool to practice, study and improve anatomical contouring; ProKnow PS – a platform for creating and comparing radiotherapy treatment plans;
- Genedrive MT‑RNR1 ID Kit can be used while further evidence is generated as an option for detecting the genetic variant m.1555A>G to guide antibiotic (aminoglycoside) use and prevent hearing loss in newborns who are being considered for treatment with aminoglycosides.
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. Two new MedTech-related MIBs published in March 2023 are:
- QbTest for the assessment of attention deficit hyperactivity disorder (ADHD), which uses an infrared tracking system and computerized tasks to assess concentration, movement, and impulsivity using age- and gender-matched comparisons;
- BPMpathway for rehabilitation support in joint replacement surgery, a remote patient assessment platform comprising a wireless, single-patient disposable range-of-motion sensor (BPMpro sensor) and a smartphone app.
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