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February 24, 2020

FDA grants breakthrough status to Altair Medical’s RESPMETER device

Altair Medical’s RESPMETER wearable biosensor device has been awarded Breakthrough Device status by the US Food and Drug Administration (FDA) in an effort to tackle the global opioid epidemic.

By Chloe Kent

Altair Medical’s RESPMETER wearable biosensor device has been awarded Breakthrough Device status by the US Food and Drug Administration (FDA) in an effort to tackle the global opioid epidemic.

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The chest-worn wireless sensor can accurately detect when someone is suffering from opioid induced respiratory depression (OIRD), a common and often fatal side effect of opioid drugs. OIRD causes 1,000 deaths each week in the US and UK and is now the largest cause of accidental death in most developed countries.

RESPMETER monitors and analyses respiratory patterns using proprietary algorithms. If it detects OIRD, it notifies designated first responders or emergency services personnel who can intervene to administer naloxone, which can revive a person within seconds.

Scotland-based Altair Medical will now receive additional support through the FDA’s Breakthrough Device Program and any submission for US approval of RESPMETER will be viewed as a priority.

Altair’s founder Dr Bruce Henderson said: “I recognised the need for a new solution to the problem of opioid deaths during my work as a forensic medical examiner. I was appalled at the number of unnecessary deaths and developed RESPMETER to combat this unmet need. Being granted Breakthrough Device designation will greatly assist the team at Altair in delivering this life-saving technology to patients.”

The Breakthrough Device Program was established to provide patients and clinicians with more timely access to transformative medical devices by speeding up their development, assessment and review.

Eligibility is restricted to medical devices that provide more effective treatment or diagnosis of life-threatening conditions where there are no approved or cleared alternatives and early device availability is in the best interest of patients.

Altair Medical chairman Jonathan Guthrie said: “This award is a major milestone for Altair Medical in our development and we are currently seeking investment to help us get this important innovation to patients and clinicians who need it as quickly as possible.”

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