PULSED AF is a 500-patient pivotal trial of Medtronic’s PulseSelect PFA system for treating both paroxysmal and persistent atrial fibrillation in patients who have not responded to drugs.
Medtronic announced that the US pivotal trial of its PulseSelect pulsed field ablation system has completed enrollment.
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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.
In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.
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.
