US FDA approves remote monitoring wearable software
The Food and Drug Association has approved the software operating Bioflux, Biotricity’s wearable heart-monitor technology. To be launched on the market in coming months, Bioflux will be given to doctors to monitor patients between visits. The company aims to continue developing other medical-grade monitoring devices to aid treatments for chronic illnesses, such as respiratory conditions and foetal monitoring applications.

Redwood City, California-based biotricity, which is working on a biometric remote monitoring solution, has received FDA clearance for the software component of their product.

The company’s first offering, which is slated for market launch later this year or early next year, is bioflux – a remote cardiac monitoring solution that includes a wearable heart monitor (to be worn on the torso) that uses AT&T’s cellular network to relay data about the wearer’s heart activity to a third-party diagnostic and emergency response team. Bioflux will be given to physicians who want more data about their patients between visits, and the duration and time the device is worn will vary depending on each patient’s particular condition.

“We founded biotricity because we saw a gap in the marketplace – you have a lot of lifestyle companies making wearables for fitness, then you have a lot of medical devices that are just restricted to the doctor’s office,” biotricity CEO and Founder Waqaas Al-Siddiq told MobiHealthNews. “We wanted to build technology solutions that can be used by the doctor and the patient. In the way that Fitbit has really revolutionized lifestyle, we want to do that for chronic conditions.”

The company aims to develop a suite of multiple medical-grade monitoring solutions for a number of chronic conditions, including respiratory illnesses and sleep apnea, and also fetal monitoring solutions.

The bioflux device is packaged as an intelligent monitor for the physician, who can use the device to diagnosis the patient’s specific condition based on abnormalities in heart activity. Currently, the solution is in a few hospital research trials. After the full solution has FDA clearance, biotricity will work on a patient-facing device as well that offers biofeedback and allows the patient to track their heart activity as well.

“If the patient has the device before really understanding what’s going on, they don’t want to fiddle with it. They may see their ECG and not know what to do with it,” said Al-Siddiq. “So the second product will address this post-diagnosis part, when it becomes a lifestyle management tool. That’s where we really see an untapped market.”