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...
Germany’s CorTec has implanted its wireless brain-computer interface in a stroke patient, launching a trial to test safety and whether brain stimulation during physical therapy can help restore movement where traditional rehab has failed.
A new MRI scanner developed by a team of scientists working with the National Institutes of Health marks a milestone in understanding the complexities of the human brain. Andrea Beckel-Mitchener with the NIH Brain Initiative discusses the significance of this potentially game-changing device.
Agent drug coated balloon, Watchman product sales, and electrophysiology (EP) business unit growth offset Acurate discontinuation and tariff headwinds. CEO Michael Mahoney shouted out coronary therapies business and answered questions on CMS proposed Ambulatory Surgical Center codes.
Despite headwinds, executives remain optimistic about growth in Abbott’s medical devices and diabetes divisions and plan several product rollouts, including the Volt PFA catheter for electrophysiology and the dual glucose-ketone sensor CGM.
