The US Food and Drug Administration (FDA) has given Glasgow-based Altair Medical’s wearable sensor its backing under a scheme aimed at accelerating the development and assessment of “transformative” medical devices for use in the market.
Under the FDA’s Breakthrough Devices Program, the company will now receive additional support from the FDA, and any submission for US approval of its Respmeter product will be reviewed as a priority.
Altair Medical’s device is a chest-worn wireless sensor that accurately detects when someone is suffering opioid induced respiratory depression (OIRD), a common and often fatal 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.
The technology monitors and analyses respiratory patterns using 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 extemely effective antidote has a very high success rate, reviving the person within seconds.
Altair 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 company’s chairman Jonathan Guthrie added: “We are currently seeking investment to help us get this important innovation to patients and clinicians who need it as quickly as possible.”
Source: The Insider