FDA Grants Breakthrough Status for Blood Oxygen Monitoring Wearable

Samara Rosenfeld
OCTOBER 29, 2019
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The U.S. Food and Drug Administration (FDA) today granted Breakthrough Device Designation to Med-botics for its wearable device which prevents respiratory arrest and death from opioid overdose.

Med-botics, a physician-owned start-up, aims to make opioids safer in the home and in the hospital.

The device, Oxalert EPO, is worn on the wrist and is intended to monitor blood oxygen levels in post-operative in-patients and home-users who are receiving opioids, according to the FDA. Oxalert EPO nudges the patient to breathe if the levels decrease below 90%.

“Providing early warning to over-sedated patients and their caregivers is important in the hospital and even more important at home,” said Richard Dutton, M.D., MBA, former executive director of the Anesthesia Quality Institute. “I am looking forward to commercial availability of this product as an important step in the effort to eradicate ‘dead-in-bed’ adverse events, as well as the many other sequelae of opioid-induced post-operative hypoxemia.”

Prior research conducted by Oregon Health Science University revealed that a pulse oximeter, headphones for verbal prompting, a nerve stimulator and a laptop prevented hypoxemia in patients after surgery, Med-botics said.

Despite the current state of public health and the opioid crisis, only 10% of the 40 million patients receiving opioids are continuously monitored, Med-botics claimed.

The start-up has a clinical trial planned and said approval from FDA will follow.

Breakthrough Devices are granted to technologies that diagnose or treat life-threatening conditions more effectively than other FDA-approved products.

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