The company pulled Harmony from the market about a year ago following six reports of the capsule at the end of its delivery catheter breaking.
Medtronic is bringing its Harmony transcatheter pulmonary valve (TPV) back to the US market nearly a year after recalling it.
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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.
The US FDA continues to issue early alerts as part of its communications pilot aimed at improving how the agency manages recalls. This time, the agency is notifying users about two separate intravascular catheters.
The US Medicare agency will hold three public meetings in June and July addressing tremor treatment devices and clinical diagnostic lab tests. The first meeting on June 25 will focus on endpoints for Parkinson’s device trials, while subsequent meetings will address payment rates and codes for laboratory tests.
Precision’s recent FDA clearance for a core part of its next-generation wireless brain-computer interface system opens the pathway to a safer, more humane BCI for researchers to use compared to higher-risk intracortical arrays, according to BCI expert Naveen Rao.
