Leman Micro Devices (LMD), the developer of regulated consumer healthcare products that is backed by major players within the mobile device industry, has announced that its V-Sensor and app – the only smartphone-integrated solution that measures blood pressure and other vital signs with medical accuracy – will satisfy new requirements imposed by changes in laws governing the use of medical devices in India, and will therefore be suitable for use in the Indian market. This is significant since leading Indian healthcare professionals have predicted a hypertension epidemic in the near future.
n an interview in the Times of India, senior surgeon Dr Ramakanta Panda explained that estimates of hypertension range from 20-40% in urban populations and 12-17% in rural areas. “People are normally not aware that they have a problem”, the Times of India quoted him saying, before going on to detail: “High blood pressure kills nearly 1.5 million people every year in South-East Asia”.
LMD’s V-Sensor is currently being readied for submission to the FDA and European Regulators, and once it has been approved, smartphone makers are expected to begin integrating it into next-generation handsets from next year. The size of the Indian population means that the device, once integrated, could play a major part in reducing the number of deaths, since the price, power consumption and size of the sensor means that there is no penalty for users, either in cost or performance. Effectively, they get a medically accurate, easy-to-use blood pressure monitor free with their next smartphone upgrade.
The new Medical Devices Rules (2017) which come into force with effect from January 31st 2018 categorize the V-Sensor in Class B and state: ‘Where a free sale certificate has already been issued in respect of any medical device by the national regulatory authority or other competent authority…a license shall be granted…without carrying out clinical investigation.’ Crucially, the smartphone itself does not become the regulated medical device; LMD’s V-sensor is the regulated element with the handset classified as an accessory.
In order to tackle the growing and deadly problem of hypertension, everyone must have access to an effective, simple and cheap method of monitoring their blood pressure. As Dr Narsingh Veerma, Secretary General of the Indian Society for Hypertension, said: “In hypertension the most important, the vital thing, is the measurement”. Smartphone ownership is becoming ubiquitous, even in poor communities, so a smartphone-integrated technology that can deliver accurate measurement is likely to prove extremely efficacious.
Added LMD CEO, Mark-Eric Jones: “India has the fastest growing market for smartphones in the world, so we sincerely hope that our V-Sensor and app can make a significant contribution to reducing the number of avoidable deaths in India, as well as in other countries.”