Onera Health Archives - Medical Design Sourcing

FDA clears Onera Health’s at-home sleep diagnostic

[Image from Onera Health]Onera Health announced today that it received FDA 510(k) clearance for its Onera STS system for polysomnography (PSG) studies.

Eindhoven, The Netherlands-based Onera’s patch-based technology aims to transform the outdated, cumbersome and expensive process of traditional sleep testing.

Onera said in a news release that its clinical-grade technology can offer an upgrade on the traditional sleep testing process that “is partly responsible” for the underdiagnosis of sleep disorders. The FD determined that the Onera STS system was “substantially equivalent” to the widely-used system for in-lab PSG studies that Natus Medical markets.

The newly cleared system combines with Onera’s digital health platform to support an end-to-end PSG service that enables and simplifies clinical-grade sleep studies with no upfront investment at a fixed fee per test.

Onera has planned a commercial launch for the end-…

CES 2022: Medical technologies you need to know

Over 2,200 companies from around the world exhibited at this year’s CES. Nearly a fifth — 417 — were digital health companies.

Wearables continue to an important role at the event, which remains hybrid virtual and in-person amid the COVID-19 pandemic. There were 276 fitness and wearables exhibitors this year, 56 more than last year.

This year also marked an important first for the health tech space, with Abbott CEO Robert Ford presenting the first healthcare keynote at CES.

As the pandemic continues, so does the trend of devices to slow the spread of the virus. CES digital health exhibitors showcased technology that detects COVID, air purifiers, body temperature thermometers and more.

Here are 7 digital health and wearable products that stood out at this year’s show.