India’s apex drug regulator has granted medical device registration to three wearable devices from GOQii, the California-based fitness technology company. These devices offer measurements of body temperature and a pulse oximeter, as well as of vitals such as Electrocardiography (ECG), blood pressure, and heart-rate, among other things.
Wearables Smart Vital, Vital 3.0, and Vital ECG have received an approval for registration from the Central Drugs Standard Control Organisation (CDSCO). While the GOQii devices offer the usual package that other wearable technologies provide in terms of activity and sleep tracking, such as steps and exercise done, it also allows for email and social notifications. Launched in November last year, Vital ECG provides ECG screening and claims to detect arrhythmias — irregular heart rates caused by heart damage. The reports, including detection of arrhythmias, are powered by Tricog Health’s algorithms, based on 30 million traces of ECG recordings.
CDSCO, under the Ministry of Health and Family Welfare, is the national regulatory body for pharma products and medical devices. GOQii was founded in 2013 by Vishal Gondal, who is also the chief executive officer, in Mumbai . “Due to the convenience of wearable technology people who used to get their vitals checked once a year are now monitoring their parameters several times a week,” Gondal said in a statement.
“We would like to commend the Ministry of Health and Family Welfare and the CDSCO for their proactive measures to regulate this area. The work of these regulatory entities will lead to profound benefits to the end-consumers in the healthcare sector, especially with regard to treatment accessibility and affordability” added Gondal.
The company added that wearable technology needs to have “exercise significant care when collecting, processing and storing personal health data”, apart from just measurement accuracy.
GOQii has also partnered with Mumbai-based K.J. Somaiya Medical College and Research Centre for a clinical study on the use of advanced wearable technology to provide doctors and medical staff with health data on COVID-19 patients.