More than accessories: Smartwatches are now becoming health devices with medical certification

These devices, so far largely considered lifestyle accessories with basic fitness-tracking features mostly shunned by medical practitioners, are increasingly receiving medical certifications from the Centre—making them health devices that alert users against issues such as heart rate fluctuations, sleep disorders and blood pressure anomalies.

On 4 December, Apple launched hypertension tracking on its latest Apple Watch Series 11 smartwatch. While the feature does not give a direct blood pressure readout, it monitors a user’s blood oxygen, stress levels and other heart-related parameters to notify them that they may have a potential hypertension issue.

The company received government approval to offer this clinical-grade feature in late November, a person aware of the development told Mint, making it only the second consumer-grade smartwatch until now to be approved by New Delhi.

Hypertension implies high blood pressure, a condition that potentially damages heart tissues in the long run. Almost one-third of all Indians suffer from it, according to the National Institutes of Health’s latest statistics.

Such features, experts and stakeholders said, represent a rising business opportunity for smartwatch makers as their popularity in India’s consumer market continues to decline. Smartwatch sales fell 34% in 2024, and 28% year-on-year in the first six months of this year.

Medical wearable adoption, on the other hand, is rising. Market research group Imarc said in October that India’s nascent wearable healthcare market, which includes smartwatches, is valued at $1.04 billion—and is projected to rise to $4.2 billion by 2033. India accounts for 2.5% of the world’s wearable healthcare market, leaving scope for significant growth here.

These, however, are still early days. In January 2024, Samsung became the first company to introduce blood pressure and electrocardiogram (ECG) features in its Galaxy Watch 6 series of smartwatches, stating then that it received clearances for it from India’s Central Drugs Standard Control Organisation (CDSCO), the statutory body for medical approvals under the Centre’s ministry of health and family welfare.

Since then and Apple’s 4 December announcement, professional athletics tracker Garmin and China’s electronics conglomerate Huawei have also launched wearables with similar features. Mint’s emails to Garmin and Huawei did not receive responses on whether they procured CDSCO certifications.

So far, consumer smartwatches have offered features such as steps, heart rate and blood oxygen monitoring, sleep and calorie tracking, and other such basic features, which do not require government clearance. However, such basic features are now available in smartwatches priced as low as under ₹1,000 ($11), leaving flagship devices such as the Samsung Galaxy Watch and the Apple Watch with the need for differentiated features.

“The only real avenue to differentiate smartwatches in the premium segment right now is to add value in terms of serious, medical-grade healthcare tracking features,” said Tarun Pathak, research director for consumer gadgets at Counterpoint India. “Apple, for instance, has built a health suite that includes menstrual and mental health trackers, and more. Specialized features require clinical trials and approvals that can be expensive, but for the likes of Apple and Samsung, this for now is the only way to increase their appeal and adoption higher up in the consumer value chain.”

In November last year, Gurugram-based fitness wearable brand Gabit introduced a wearable ring, which offered features such as heart rate variability tracking, and skin temperature monitoring to preemptively detect flu and other common ailments.

Both, however, are yet to see widespread adoption—and much of India’s billion-dollar wearable healthcare industry right now is driven by clinical monitors in hospitals supplied by Philips, Nikon and Abbott.

Doctors, though, remain bullish on the rising prospect of medical-grade health features in mainstream smartwatches, and believe they can lead to proactive diagnosis of hard-to-detect health issues.

“Usage of smartwatches has begun offering vital guidance on regular health tracking,” said Dr Amitabha Bhattacharya, a practicing general physician in Kolkata and honorary state secretary of Indian Medical Association, West Bengal chapter. “While much of it has so far been informal and with ample inaccuracies, new generation wearables have begun offering clinical-grade tracking of health statistics, which can help patients, particularly in borderline chronic and long-term ailment risk, to be diagnosed much faster than what was possible before.”