The FDA has given De Novo approval to the Masimo Opioid Halo, an opioid overdose prevention and alert system. It is the first FDA-cleared monitoring system for detecting opioid-induced respiratory depression, the leading cause of death from opioid overdose.
With this, Masimo also became the first winner of the FDA Opioid Innovation Challenge to have an authorized solution designed to help solve the U.S. opioid crisis, according to the company in a press statement.
The approval