US FDA approved Medtronic PLC's HeartWareHVAD left-ventricular assist device system as a "destination therapy" for patients with advanced heart failure who are not candidates for heart transplants.
US FDA Approves Medtronic's HVAD For Destination Therapy
The expanded labeling gives Medtronic's HVAD, acquired when it bought HeartWare last summer, the same indication as Abbott's HeartMate II ventricular assist device.
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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.
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“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.
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A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.
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Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.
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Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.