Compumedics Somfit, has been cleared by the US Food & Drug Administration (FDA) to be marketed in the USA.
Designed and manufactured in our headquarters in Melbourne, Australia, Somfit®, is the latest addition to Compumedics sleep monitoring device family.
Somfit is a wearable device for collecting patients’ physiological data, primarily for use in assisting medical professionals to diagnose sleep disorders. It is light and comfortable for the patient, whilst enabling collection of high-quality signals to provide medical-grade data. The ability to conduct at home monitoring using Somfit eliminates the need for patients to travel to a hospital or sleep clinic, which can be time-consuming and inconvenient.
In the USA, Somfit can be used as a reimbursable diagnostic device if the doctor suspects Obstructive Sleep Apnea (OSA).
In the United States, there are two million studies conducted per year in the home testing market (HST) utilizing the Peripheral Arterial Tonometry technology, which is central to the Somfit performance. Compumedics believes that the Somfit technology platform, offers a clear competitive advantage and superior value to alternate technologies currently on the market, by being highly scalable, offering a clinical grade technology for use in the home, greater convenience and ease of use for the patients, along with an overall reduced cost.
David Burton noted, “Following FDA clearance for the Somfit device in the USA, Compumedics can now begin executing their commercialisation strategy to capitalise on the under penetrated sleep market with an initial focus on Home Sleep Testing (HST), before addressing other opportunities.”
The Somfit system comprises of the Somfit device, a disposable adhesive electrode and a phone app.
About the Somfit technology
The Somfit technology comprises of a number of market-specific and disorder-specific diagnostic products which offers several advantages to organisations operating in the sleep diagnostic space:
- Highly scalable: Quality health SaaS 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 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 Somfit product has received regulatory clearance for sale in Australia, New Zealand, the EU, UK and now, the USA.