GOQii bags CDSCO med device registration for GOQii Smart Vital, Vital 3.0 and Vital ECG

Registration adds quality assurance tag to wearables; company hopes to move complete manufacturing to India within the next 12 to 18 months

In a positive step towards quality assurance, GOQii has received medical device registration for the GOQii Smart Vital, Vital 3.0 and Vital ECG from the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare, which is the national regulatory body for Indian pharmaceuticals and medical devices.

With the next wave of healthcare innovation likely come from digital therapeutics and software-based treatments Vishal Gondal, Founder & CEO, GOQii commended 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,” he added.

In line with the Government of India’s push towards Atmanirbhar Bharat, GOQii is also reportedly making strides towards moving its manufacturing base to India. The company has already shifted some assembly activities to India. However, with the launch of several medical device manufacturing hubs across India and the incentives being offered in them – the company is hoping to move its complete manufacturing activities to India within the next 12 to 18 months.

GOQii is also piloting the technology for its use as a remote health monitoring tool. The company is apparently already working with civic bodies, police departments, production houses and multinational companies to provide end-to-end remote health monitoring services.

Gondal added, “The virtues of the preventive approach to healthcare cannot be overstated. The challenge with preventive medicine is that people lack tools that provide detailed data snapshots of their current health. GOQii aims to change this with their wearable integrated approach to healthcare delivery and service. This technology has the potential to positively impact long-term patient outcomes across the continuum of care. 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.”

Wearable technology presents many compelling opportunities for improving healthcare. The use of wearables can enable healthcare consumers to analyse their biomarkers, receive digital coaching services and benefit on their insurance plans. It also enables the medical community to use biomarker analysis in remote prognosis and treatment. The technology will lead to paradigm shifts in the healthcare industry from a ‘sick-care’ model to a preventive or wellness-based model.

As per the release, many patients with challenging lifestyle conditions like NAFLD, diabetes and hypertension, have already improved their outcomes from the company’s digital coaching services, delivered in partnership with third-party pharmaceutical partners.

When discussing wearable technology, along with measurement accuracy the technology needs to have a strong data security architecture. Healthcare technology firms have to exercise significant care when collecting, processing and storing personal health data. While sharing health data may be the key for medical innovations that transform patient care, GOQii reportedly understands the same needs to be handled with integrity and responsibility.

Wearable technology has the potential to transform healthcare and healthcare research by enabling accessible, continuous and longitudinal health monitoring. As per the company release, GOQii has partnered with K.J. Somaiya Medical College and Research Centre for a seminal clinical study on the use of advanced wearable technology to provide doctors and medical staff with detailed health data on each COVID-19 patient under their care in real-time. The initial results of the study are promising, and an absolute focus has been laid upon the accuracy of the device.