The US Food and Drug Administration (FDA) has granted 510(k) clearance to Australia-based Compumedics’ Somfit device—an adhesive device worn on a patient’s forehead to collect physiological data, used primarily to assist in diagnosing sleep disorders—for marketing in the US.

The device previously received regulatory clearance in Australia, New Zealand, and the European Union. 

“Following FDA clearance for the Somfit device in the USA, Compumedics can now begin executing their commercialization strategy to capitalize on the underpenetrated sleep market with an initial focus on home sleep testing, before addressing other opportunities,” says Compumedics executive chairman and CEO David Burton in a release. 

Compumedics has appointed new sales staff in the US to commence initial commercialization activities and will be pursuing several focused opportunities available to it following the FDA clearance. 

The Somfit technology comprises a number of market- and disorder-specific diagnostic products that offer several advantages to organizations operating in the sleep diagnostic space, according to a release from the company:

  • Highly scalable: quality health software as a service business model
  • Clinical grade data in an at-home device: Light and comfortable for the patient while enabling collection of high-quality signals to provide medical-grade (reimbursable) data
  • Greater convenience: At-home monitoring eliminates the need for patients to travel to a hospital or sleep clinic, which can be time-consuming and inconvenient.
  • Reduced cost: At-home monitoring is less expensive than hospital monitoring, as it eliminates the need for hospital staff and facilities.

The go-to-market strategy has, to date, been developed around an initial focus in Australia, targeting three main areas:

  • The existing obstructive sleep apnea home sleep testing market
  • The primary care market for sleep screening and OSA diagnosis
  • Supporting the diagnosis of insomnia and circadian rhythm disorders

This initial Australian focus has allowed Compumedics to further refine the initial design through high-volume local testing, according to a release from the company, which notes it anticipates further announcements as it continues its commercialization activities for Somfit in Australia and now the US.