Masimo is the first company to receive FDA clearance for a device to prevent accidental overdose of opioids. It will be made available to the public in May in addition to a prescription model for health care providers.
Masimo Corp. announced on 3 March it received US Food and Drug Administration de novo clearance for a wearable system used to detect opioid-induced respiratory depression, the leading cause of death from opioid overdose.
The device is intended for individuals 15 years and older and will be sold both over the counter without a prescription and will also be made available with a prescription...
Haemonetics will acquire Quebec-based OpSens for CAD $2.90 per share, or about US $253m at current exchange rates. Haemonetics expects OpSens' fiber-optic technology to complement its interventional cardiology portfolio.
The retail giant will sell the Dexcom G7 continuous glucose monitoring system to eligible customers through a new online platform.
Stimdia is trying to restore respiratory function in ICU patients with phrenic nerve stimulation.
Reuters reported that global private equity firm Carlyle Group has offered to pay at least $7bn for Medtronic’s patient monitoring and respiratory interventions businesses. Medtronic announced its plan to get out of those businesses about one year ago.
During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.
Handheld diagnostics are more powerful, accessible and clinically relevant than ever. Medtech Insight spoke to companies behind such technologies to learn how they work and discuss their commercial models.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
