FDA clears Oxitone's wrist-worn pulse ox for remote patient monitoring

By Jonah Comstock
05:25 pm

Ashkelon, Israel-based Oxitone Medical has received FDA clearance for a wristworn pulse oximeter that doesn't require a finger clip. According to the company, the device – the Oxitone 1000 – can pick up SpO2 and pulse rate with the same accuracy as traditional fingertip pulse oximeters.

The device has a consumer-friendly form factor, but Oxitone is targeting the clinical market. The design of the wearable is an adherence play, as the company hopes that a more comfortable device will be worn more consistently by home monitoring patients than a bulky fingertip unit. Measuring from the wrist also allows patients' blood oxygenation to be monitored while they participate more naturally in everyday activities.

“The Oxitone transformative solution redefines the way measurements happen. We shift a care paradigm towards unification of hospital and home care of chronic diseases,” Oxitone founder and CEO Leon Eisen said in a statement.

Oxitone Medical has been developing the device for at least four years. The company was a member of the inaugural class of StartUp Health's partnership with GE Healthcare in 2013. Startups in the three-year program were enrolled in the StartUp Academy along with about 65 other companies, but also received additional benefits like a dedicated GE executive mentor and access to a "virtual commercial laboratory" to test business models, pricing strategies, and pilot programs.

The wearable itself is just part of a larger remote monitoring platform play for the company. Eisen also expounded on the company's future plans in a statement.

“Our vision goes far beyond just wrist-sensor pulse oximeter," he said. "The next step is to integrate the bracelet with our patient management and monitoring digital health platform that includes a companion patient/caregiver mobile application and cloud supervisor’s portal. Our platform transforms real time health data into patterns, alerts, predictive analytics and life management notifications. As a specific example, by real-time monitoring of oxygen saturation, pulse and activity level, COPD exacerbations can be detected early, clinical interventions can be initiated immediately and readmission prevented. We believe that our solution will deliver a great value for patients and providers, and significant savings of funds.”

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