VitalConnect gets FDA nod to extend VitalPatch life from four days to five

By Jonah Comstock

Disposable vitals sensor maker VitalConnect has received a new FDA clearance, lengthening the life of its VitalPatch device from four days to five.

VitalPatch is an FDA-cleared, disposable peel-and-stick health sensor, which continuously monitors eight different vitals (ECG, heart rate, heart rate variability, respiratory rate, skin temperature, posture, and steps, as well as automatic fall detection) in real-time. It’s designed for inpatient and outpatient hospital use. Via Bluetooth, the sensors send the data to either a connected app or hub, then onwards to a cloud-based server where it can be accessed by the user’s care providers.

“Since the product is fully disposable, how many days you can have it is an important factor. This is not a rechargeable device or changing the battery or anything like that,” Dr. Nersi Nazari, CEO and founder, told MobiHealthNews. “We started with four days for the device and over the last two years, we were able to increase the life by 25 percent to make it a five-day device. … We’re very happy about it because most hospital stays in the US are 4.5 days or so. So now, with one device, the patient can be managed throughout their stay in the hospital.”

That figure about the average hospital stay comes from the Agency for Healthcare Research and Quality. The change from four days to five means time saved in nurses not having to change the device during the patient’s stay and money saved as hospitals will have to purchase fewer patches, Nazari said.

“The cost of keeping a patient in their room is a really expensive expense for a hospital. What we do adds tens of dollars to that patient stay; we’re not talking about hundreds of dollars,” Nazari said. “So [the value to hospitals is] just the time that is saved by the nurses to go and take measurements and the rest the patient gets because they don’t have to be woken up to take their breathing rates, heart rates, and so forth.”

VitalConnect is operating in an increasingly competitive space on several fronts, but it still offers a unique combination in a disposable, connected, clinically validated device. Recent advances in EKG monitoring by AliveCor and Apple, for instance, are consumer-focused and involve expensive, non-disposable devices, while iRhythm Zio, a take-home EKG monitoring patch, doesn’t send data wirelessly but rather must be mailed in for a manual data download. (The company recently announced functionality that would allow the wearer to send snippets of data wirelessly, but the bulk of the data collection will still happen by mail after the fact).

Perhaps the biggest potential threat to VitalConnect on the horizon is still a little ways off. Qualcomm announced in September that it would work with electronics company Benchmark to create low-cost, disposable biometric patches. That launch is targeted for 2018 but initially the patches will monitor just temperature and motion.

Link to Article: MobiHealthNews