Oxford University spinoff Oxehealth has received an FDA De Novo clearance for software that can estimate pulse rate, heart rate, respiratory rate and breathing rate from a video camera signal.
Founded in 2012, the company has often likened its technology to that of a pulse oximeter, which detects minute visual changes in skin color to measure blood oxygen levels.
In this case, the Oxehealth Vital Signs system uses algorithms to analyze video to "identify pixel-level changes that correlate with pulse and breathing rates" according to the FDA's product classification page. This approach is noninvasive and, according to the company, less obtrusive than other vitals-monitoring devices that are worn or clipped onto the body.
The agency reached its decision on Friday – just a day shy of a year after Oxehealth had submitted its application, according to the listing. Oxehealth also updated the medical device disclaimer page on its website yesterday to reflect the product's indications.
The company said that the system is indicated for use on adults aged 18 years or older who do not need critical care or continuous vital sign monitoring. The Oxehealth Vital Signs device is a fixed installation for use in single occupancy rooms in certain provider settings where professionals periodically check on the patient's safety.
The company noted that activity detection, fall risk, activity tracker and sleep products included as part of the product offering do not have a medical purpose, however, and are not to be used when making medical or clinical decisions.
WHAT'S THE IMPACT
The company's technology was accredited as a Class IIa medical device by European regulators in 2018. At the time, CEO Hugh Lloyd-Jukes said that the system would be "hugely beneficial" to organizations caring for the elderly and vulnerable, as it allows staff to check in on patients without needing to enter their room or disturb their rest.
The company has since deployed its service – the hardware installation with its accompanying software monitoring platform – to a number of U.K. mental health and acute hospital trusts, and even police forces that it said were piloting the technology for use in prisons.
The company noted that COVID-19 had driven an increased need for contactless monitoring technologies, and in a funding announcement from earlier this month said that annual revenue had doubled in 2020 alone.
Lloyd-Jukes said at the time that the investments would support commercial growth "in Europe and beyond over the next two to three years." FDA clearance would support such an expansion into the U.S.
MobiHealthNews has reached out to Oxehealth for a comment on the regulatory clearance and its resulting business plans, and will update this story with any comment.
THE LARGER TREND
Oxehealth's observations of increased demand for patient-monitoring technologies have been echoed by competitors in the space, of which there are many. Notably, the FDA expanded the use of vital-sign monitors to allow for increased remote-care capabilities right at the head of the pandemic, rolling out the red carpet for many providers and vendors to rework their offerings for less person-to-person contact, or for remote patient-monitoring approaches that extend beyond the four walls of the hospital.
Outside of healthcare, Oxehealth's approach to measuring respiration and pulse vitals from video imagery is right in line with new wellness tools rolled out in recent weeks by Google. In that case, the tech giant built its own algorithm-powered wellness feature that uses a smartphone camera to track color changes in users' skin and in the motion of their chest cavity – thereby requiring no additional hardware.