Dive Brief:
- Scottish medtech startup Altair Medical said Monday it received FDA's breakthrough device designation for a wearable biosensor technology it's developing to detect a potentially fatal side effect that can occur in people using opioids.
- The company's chest-worn wireless sensor, called Respmeter, has algorithms designed to monitor respiratory patterns and identify when a user is experiencing opioid-induced respiratory depression. The device then notifies emergency responders to administer overdose antidote naloxone.
- Opioid overdose is a leading cause of accidental death in the U.S., a specific problem the founders of Altair Medical wanted to target when forming the company in 2018. Altair is in the process of seeking investment to get the device to market, according to the company's statement.
Dive Insight:
The medtech industry has become increasingly involved in responding to the opioid crisis the past few years, spurred in part by regulators.
At the end of 2018, FDA tapped eight companies developing devices to address opioid abuse for increased collaboration in an attempt to speed diagnostics, pain therapies, and medication dispensing and patient monitoring solutions to market. Around that time, digital therapeutics developer Pear Therapeutics won FDA clearance for an app-based treatment to help people with opioid use disorder.
Late last year, medtech startup Med-botics received breakthrough designation for a wrist-worn device meant to prevent respiratory arrest and death from opioid overdose by monitoring blood oxygen in opioid recipients and prompting them to breathe if oxygen falls below a certain level.
Makers of pain medication infusion pumps have also positioned the devices as safer alternatives to oral opioid drugs and lobbied the Trump administration to increase reimbursement.
A breakthrough device designation, reserved for products in development that may more effectively treat or diagnose life-threatening or irreversibly debilitating diseases or conditions, entitles companies to closer interaction with FDA during device development. CMS has also set up a system to fast track reimbursement for breakthrough devices that succeed in obtaining marketing authorization from FDA.
Other breakthrough device designations announced by recipient companies this month include a predictive lung cancer test, a software as a medical device Parkinson's Disease monitoring platform, a DNA test for people at elevated risk for esophageal dysplasia because of chronic gastroesophageal reflux disease, and a transcatheter tricuspid valve replacement system.