A wearable biosensor device that aims to help tackle the global opioid crisis has been given Breakthrough Device designation by the Food and Drug Administration (FDA).
Altair Medical’s Respmeter is a chest-worn wireless sensor that detects when someone is suffering Opioid Induced Respiratory Depression (OIRD), a side effect of using opioid drugs. Causing 1,000 deaths each week in the UK and USA, OIRD is now the largest cause of accidental death in most developed countries.
Jonathan Guthrie, chairman of Altair Medical, 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.”
The technology monitors and analyses respiratory patterns using proprietary algorithms. When it detects OIRD in the patient, it sends a message to designated first responders, or emergency services, who can intervene to administer naloxone. This antidote has a high success rate, reviving the person within seconds.
To achieve Breakthrough Device Status a panel of experts at the FDA extensively reviewed both Respmeter and its prospective users. Following the confirmation of this designation, the company will now receive additional support from the FDA, and any submission for US approval of Respmeter will be reviewed 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 status will greatly assist the team at Altair in delivering this life-saving technology to patients.”
