Medical devices approved outside the US in October include Medtronic's CoreValve Evolut R, Edwards' Acumen Hypotension Probability Indicator, and two approvals – for two completely different indications – for Ra Medical Systems' excimer laser technology.
[Editors' note: For sortable and searchable tables of all 2016 US and non-US approvals and clearances, check out the Approvals Tracker at medtech.pharmamedtechbi.com/datasets/approvals.]
Edwards Lifesciences Corp.'s Sapien 3 will have stiff competition in Canada now following Health Canada's license of Medtronic PLC's CoreValve Evolut R valve with the EnVeo R delivery...
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.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
