Dive Brief

Acurable is preparing to challenge ResMed and Resonea for the sleep apnea diagnosis market in the U.S.

Having received 510(k) clearance in February, Acurable plans to start selling its AcuPebble Ox100 device in the U.S. this summer. The device records the sounds of the patient's respiratory and cardiac functions and monitors blood oxygen levels to assess suspected obstructive sleep apnea.

ResMed acquired a rival device, now sold as onesleeptest, through its 2021 Ectosense takeover and Resonea offers some of the same capabilities through its Drowzle Pro mobile application.

Dive Insight

AcuPebble Ox100 builds on an older Acurable device, AcuPebble SA100, that received 510(k) clearance in the summer of 2021. Like the older device, AcuPebble Ox100 features a sensor that the patient sticks to their neck to record respiratory and heart sounds. The acoustic signals are processed and analyzed by algorithms to detect sleep apnea.

The new device combines the neck sensor with an oximetry sensor that the patient wears on their finger to record blood oxygen levels. While the AcuPebble SA100 clearance said the device is "not intended as a substitute for full polysomnography," the FDA notification for the new product lacks that caveat.

Esther Rodriguez-Villegas, inventor of the AcuPebble technology and founder and co-CEO of Acurable, said in a statement that the company has "already had a lot of interest from U.S. clinicians, who believe it can be transformational [for patients]."

"Accessing a diagnosis and the diagnostic test itself has for too long been uncomfortable and inconvenient for patients, and far too time-consuming for clinicians," Rodriguez-Villegas said. "The AcuPebble device is set to change that, by making it far simpler for patients to get tested and for doctors to access the results, saving billions of dollars in the process."

Other companies already sell devices with similar capabilities in the U.S. Acurable cited the devices as predicates and references in its 510(k) filings. Resonea's mobile app uses smartphone microphones to capture the sounds of sleeping patients with suspected sleep apnea. ResMed's onesleeptest, also known as Ectosense's NightOwl, is a finger-worn sensor that tracks pulse rate, oxygen saturation and movement.

AcuPebble Ox100 tracks a wider range of sleep-related variables than either of the rival devices. With a launch on the horizon, work is now underway to try to translate those differences into commercial sales.