Posted by MobiHealthNews on February 16, 2017.
A Swiss medical device company is working on a medically accurate sensor, built into a smartphone, that could return results about heart rate, respiration rate, blood oxygenation, temperature, and — the use case the company is initially focusing on — blood pressure. Leman Micro Devices (or LMD or Elemdy) is beginning trials now to simultaneously submit the device for regulatory clearance with the FDA, the CE Mark, and a number of other regional regulators, with the goal of licensing the technology to major smartphone makers to build into their devices within a few years.
“The important thing about our approach which seems unique — and we have patents on this — is we actually use the same science that was being used by doctors for a long time with a cuff on the upper arm to measure blood pressure,” LMD CEO Mark-Eric Jones told MobiHealthNews. “And that is to change the pressure outside the body and see at what pressure the blood flow stops and starts, both at the systole when the heart is pumping and the diastole when it’s relaxed. So it’s very old science, we’re not trying to apply new science to any of these measurements. What we’re trying to apply is new technologies to make it very low cost and integratable into a smartphone.”
That’s an important distinction, given the somewhat rocky history of app-based blood pressure monitoring. Aura Labs, the company behind Instant Blood Pressure, an app that purported to measure blood pressure using only the smartphone’s camera, was recently investigated by the FTC.
“There have been a number of companies that have tried to apply new science and work out blood pressure just by the speed of propagation of a wave in the artery, and we really don’t think that ever will be accurate enough for medical applications,” Jones said.
LMD is starting with blood pressure because hypertension is a disease that’s both very deadly — the World Health Organization estimates someone dies from high blood pressure every three seconds — and extremely treatable. The problem is many people don’t know they have it, and so building an accurate and reliable sensor into a smartphone could make a big difference.
Once LMD secures the regulatory clearances, if all goes well, they hope to see their sensor built into future generations of smartphones.
“I can’t go into specific details, but we’ve already had a lot of discussions with a number of [smartphone companies] and that’s why we’re continuing down this path,” Jones said. “We’ll also supply the software. As you’re aware, the cost of anything in a smartphone is very critical, particularly as companies more and more see lower income countries as the biggest markets. We’ve put a lot of effort into cost engineering the sensor to make it very low cost and put as much as possible into the software on the smartphone, not in additional hardware.”
Jones says that in addition to making in-roads with smartphone companies, LMD has had some initial conversations with regulators, to make sure the device isn’t a nonstarter.
“We already have a written confirmation from several regulators that because of what we’ve proposed and our technology, they will not regulate the phone itself, only our sensor,” he said. “That of course is a very important advantage for the smartphone companies, which don’t want to go through regulatory approvals.”