Oct. 3, 2025
| Today’s news and insights for medtech leaders
A 510(k) submission now planned for this quarter sets up a potentially faster clearance than the de novo pathway originally planned, the company said.
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Use of real-world evidence to support regulatory decisions and predetermined change control plans for medical devices are two areas of focus for the agency.
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The company plans to launch the device in Europe late next week, providing competition for AtriCure’s AtriClip product.
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The company has now treated 500,000 patients with its pulsed field ablation system, in a competitive category poised for growth.
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News Roundup
The clearance gives Distalmotion, which sees opportunity in ambulatory settings, a third robotic procedure category in the U.S. Elsewhere, AiM Medical Robotics raised $8.1 million.
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Device comfort and performance hinge on one critical component: the right wearable adhesive. Learn how early wear studies can differentiate your device and boost market success in this webinar.
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