The approval, based on the results of the SURTAVI trial, comes a few months ahead of analysts' expectations and is welcome news for Medtronic in its effort to keep pace with TAVR leader Edwards in the US market.
US FDA approved Medtronic PLC's CoreValve Evolut transcatheter aortic to treat patients at intermediate risk for open-heart surgery just four months after the company filed the pre-market approval supplement for the expanded indication, the company announced July 10.
The CoreValve Evolut platform includes CoreValve, CoreValve Evolut R and the CoreValve Evolut PRO transcatheter valves. FDA approved CoreValve Evolut Pro in March and the company expects to launch Evolut...
The US FDA has approved the Teal Wand, the first at-home cervical cancer screening device. Capable of detecting preclinical cancer with 96% accuracy, it will launch in California in June and expand nationwide soon after.
NeuroOne is preparing to submit its OneRF Trigeminal Nerve Ablation System to the US FDA for treating trigeminal neuralgia, a chronic facial pain condition. CEO Dave Rosa told Medtech Insight that he expects a possible product launch by fall 2025.
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.
“We believe [the SAPIEN M3] launch alongside PASCAL and EVOQUE will help support the company’s target of $2bn in transcatheter mitral and tricuspid therapies sales by 2030,” noted analysts from Leerink Partners.
