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.
Ashis Barad was hired a year ago as the Hospital for Special Surgery’s first chief digital and technology officer. The New York-based academic medical center, known for its orthopedics program, made ...
The company plans to launch the device in Europe late next week, providing competition for AtriCure’s AtriClip product.
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.
The company has now treated 500,000 patients with its pulsed field ablation system, in a competitive category poised for growth.
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.
Boston Scientific also foresees future growth in its Watchman business from a planned label expansion and concomitant procedures. The company expects the market for its Watchman device, estimated at ...
The medical device industry has a jam-packed year of events for professionals to attend, including the J.P. Morgan Healthcare Conference, DeviceTalks Boston and AdvaMed’s annual medtech meeting.
The FDA’s call for feedback is informed by evidence that the performance of AI-enabled medical devices can change over time. As the agency explained in its request for comment, factors such as changes ...
After a successful pilot, the agency has lifted the limitations on when it will provide early information about potentially high-risk safety events.
The number of medtech funding rounds has declined in recent months, but the value of overall deals has increased, according to a new report from EY.
The Essilor Stellest eyeglass lenses are designed to slow myopia progression in children. The lenses have a clear 9mm diameter area in the center. Rings of tiny raised dots surround the clear center ...
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