Feature: Medical
also in regulated medical devices from companies such as Oxitone Medical and others. The fundamentals of the technique
in the different devices are similar. However, without the formal regulatory approval, the non-medical devices can display a rough indication of spO2
over
time, or build it into rough aggregate health metrics, but cannot link it to any formal medical claim such as detection of sleep apnoea, for example. Another increasingly popularity
metric added to smartwatches is blood- pressure monitoring. Patents go back over a decade (e.g., from CSEM), but more modern versions now involve optical blood pressure measurement. Omron and others have taken the principles of the blood pressure cuff and used them within FDA Class II cleared smartwatches, whereas other vendors produced similar devices based on the “occlusive” method. There is also a
move toward a “cuffless” optical blood- pressure detection. Last year saw yet another promising
area of interest – that of “hearables”. Valencell is just one company making products in this field, but there’s likely to be a complex ecosystem with different levels of medical capabilities in wearables, with varying degrees of regulatory approvals.
Fitness, wellness or medical? All these applications overlap, with device functions being classed as either fitness/wellness or medical/healthcare, depending on their regulatory clearance. Products on the fitness/ wellness side can use any metric of the general health-assessment algorithms, but can’t provide specific medical metrics or diagnoses. Regulatory clearance means they have been specifically benchmarked against previously-approved medical products
and produce equivalent performance in the specific area of assessment. For most medical devices, regulatory
approval or clearance is an essential prerequisite to commercial sales. However, smartwatches now join groups of other wearables that are seeking formal medical device approvals, which will create new application areas (for example electrical muscle stimulation rehabilitation), often resulting in higher sales prices. On the other hand, it takes up a lot of time and money to get the approval in the first place, even though performance can often be the same between the medical and non-medical wearable device. The situation is similar with
smartwatches. The FDA clearance for ECG, atrial-fibrillation alerts and more will open up new application possibilities for these devices. Medical approval will give smartwatches an interesting marketing edge.
HIGH ACCURACY THERMISTORS
MEDICAL AUTOMOTIVE
E-VEHICLE CHARGING
RECHARGEABLE BATTERIES
• Fast Thermal Response
• High Accuracy • Interchangeability
YEARS OF MAKING
25
TECHNOLOGY SAFER
ATC Semitec’s wide range of NTC thermistors are ideal for use in all types of temperature measurement, and temperature monitoring. Typical applications include catheters, small probes, medical devices, temperature monitoring equipment and portable batteries.
Semitec F-Micro (on reel)
www.atcsemitec.co.uk
Semitec FT SMD
Semitec JT
ATC Semitec SP
NEED ADVICE? Call us now on 01606 871680 or email
smart@atcsemitec.co.uk for technical advice & samples
ATC Medical ad 180x125 - ELECTRONICS WORLD
AW.indd 1 17/03/2021 10:50
www.electronicsworld.co.uk May 2021 39
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