The six-month results from SPYRAL HTN ON MED trial of Medtronic’s Symplicity Spyral renal denervation system did not meet its primary endpoint, but the company and analysts expect the FDA will still approve Symplicity Spyral as the first renal denervation system available in the US to treat uncontrolled hypertension.
Medtronic is confident the US Food and Drug Administration will approve its Symplicity Spyral radiofrequency renal denervation system to treat uncontrolled hypertension, even though one of the pivotal trials supporting the system missed its primary endpoint.
Medtronic submitted the fifth and final module of the Symplicity Spyral premarket approval application package to the FDA on 7 November, Jason Weidman, president of Medtronic’s coronary and
The REFLECT studies showed a 78% reduction in cardiovascular disease-related hospitalization for people living with type 1 diabetes with prior low blood sugar episodes.
After publishing encouraging results from first-in-human trials of its brain-computer interface, Axoft announced plans to sell its BCI-enabling material Fleuron to researchers and private organizations for R&D use. The company sees this as a revenue stream and feedback loop to refine its BCI platform designed for safer, longer-lasting brain implants.
Peerbridge Health is preparing to submit its next-generation ECG patch, CorMDx, for US FDA clearance this quarter, with plans to launch in the second half of 2025. The rechargeable device is designed for continuous, real-time heart monitoring from the hospital to home, aiming to detect early signs of heart failure and reduce emergency room visits.
