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 December, NICE issued one new medical technologies guidance on Zio XT for detecting cardiac arrhythmias. Zio XT (iRhythm Technologies) is a remote cardiac monitoring service used to detect cardiac arrhythmias. It has three components:
- Zio biosensor: a wearable single-lead ambulatory electrocardiogram (ECG)
- ZEUS: a proprietary, regulated software platform and online portal that stores, analyses, and sorts the ECG data to generate a report of the findings
- Zio technical report: a clinically actionable summary of the recorded ECG data
NICE recommended Zio XT as an option for people with suspected cardiac arrhythmias who would benefit from ambulatory electrocardiogram (ECG) monitoring for longer than 24 hours only if NHS organizations collect information on:
- resource use associated with the use of Zio XT
- longer-term clinical consequences for people who have monitoring with Zio XT (such as incidences of further stroke, transient ischemic attack, and other thromboembolism, arrhythmia-related hospitalizations, mortality, uptake of anticoagulants, or other changes in medication related to the monitoring result)
NICE concluded based on evidence that Zio XT is convenient and easy to wear, with an improved diagnostic yield (a measure of how many people with cardiac arrhythmia are diagnosed) compared with standard 24‑hour Holter monitoring. The technology is likely to be cost-neutral or cost-saving compared with 24‑hour Holter monitoring, but more evidence is needed.
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.
Three MedTech Innovation Briefings were published in December:
- ReStore Soft Exo-Suit for gait rehabilitation - a device designed to help people having walking gait training after a stroke or brain injury
- Cytosponge for detecting abnormal cells in the esophagus in conditions such as Barrett's esophagus. It is a single-use minimally invasive esophageal sampling device known as a 'sponge on a string' pill test. The spherical sponge in a dissolvable capsule is used to collect cells from the esophagus, which can then be tested by an antibody test to detect Trefoil Factor 3 (TFF3)
- Evoke Spinal Cord Stimulator for managing chronic neuropathic or ischemic pain - a rechargeable, implantable, closed-loop stimulator for chronic pain management. It uses feedback control by recording neural tissue activation and automatically adjusting spinal cord stimulation to ensure it remains in the therapeutic range. Also, Evoke can be programmed and used as an open-loop (which gives a fixed output of stimulation), similar to conventional spinal cord stimulation systems
Also, nine clinical guidelines were updated in December:
- Pancreatitis [NG104]
- Eating disorders: recognition and treatment [NG69]
- Low back pain and sciatica in over 16s: assessment and management [NG59]
- Type 2 diabetes in adults: management [NG28]
- Type 1 diabetes in adults: diagnosis and management [NG17]
- Diabetes (type 1 and type 2) in children and young people: diagnosis and management [NG18]
- Diabetes in pregnancy: management from preconception to the postnatal period [NG3]
- Recommendations changed for continuous glucose monitoring (CGM) and intermittently scanned CGM (isCGM, also commonly referred to as flash (FGM)) for pregnant women with type 1 diabetes
- Osteoarthritis: care and management [CG177]
- Peripheral arterial disease: diagnosis and management [CG147]
See the full details here.
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