The software-only medical device uses video analysis to assess patient movement, activity, and physiological signs in inpatient settings.


Summary: Oxehealth has received FDA 510(k) clearance and CE Mark approval for its new software, Oxevision Sleep. This noncontact sleep monitoring device uses video analysis to assess patient movement, activity, and physiological signs in inpatient settings without attaching devices to patients. The software generates sleep reports for healthcare professionals, addressing the challenge of obtaining accurate sleep data in acute mental health care. Oxehealth is now seeking mental health providers to join its Innovator Program and is expanding its partnerships in the US and Europe.

Key Takeaways: 

  • Oxevision Sleep by Oxehealth has received FDA 510(k) clearance and the CE Mark, enabling its use in the US and EU for noncontact sleep assessment.
  • The software uses video analysis to monitor sleep without attaching devices to patients, providing valuable sleep data in inpatient settings.
  • This technology aims to improve care plans and recovery in mental health settings by offering accurate sleep insights, with Oxehealth expanding its partnerships in the US and Europe.

Oxehealth, a developer of intelligent patient monitoring for acute mental health, announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) and the CE Mark in the European Union for its new sleep monitoring software, Oxevision Sleep.

Oxevision Sleep is a software-only medical device that provides noncontact sleep assessment in the inpatient setting based on the analysis of patient movement, activity, and physiological sign data derived from video, without the need for contact devices to be attached to the patient or bed, according to the FDA’s summary.

The device consists of software that assesses video footage collected using off-the-shelf cameras installed within single-occupancy bed spaces within hospitals, general care, and secured environments. The device software automates the recognition of sleep periods and generates sleep reports for use by a healthcare professional.

Key in Mental Health Settings

Given the links between sleep and mental health, sleep insights should be a key part of providing the best care and treatment. But until now, obtaining objective and accurate sleep data in acute mental health has been a challenge, according to a release from the company.

“In inpatient psychiatric settings it is impractical and unsafe to attach standard polysomnography equipment to patients,” says Dr Michael Genovese, a member of Oxehealth’s advisory board, in a release. “Oxehealth’s novel solution has such huge potential. The insights it provides can support clinical teams to tailor their care plans and promote recovery. Ultimately it could even allow clinical teams to refine medication prescriptions and optimize length of stay.”

Todd Haedrich, CEO of Oxehealth, adds in a release, “We are excited to announce our latest world-first breakthrough. We are now actively seeking acute mental health providers who are forward thinking and interested in leveraging technology to advance their capabilities to join our new Innovator Program.”

Oxehealth partners with half of NHS England’s mental health providers and is expanding to the US and Europe.