HeartBeam’s arrhythmia assessment system gains FDA 510(k) clearance
Distinguished by its credit card size and cable-free design, the device is claimed to be the first of its kind to be cleared by the US regulator.
17 December 2024
17 December 2024
Distinguished by its credit card size and cable-free design, the device is claimed to be the first of its kind to be cleared by the US regulator.
Olav Bergheim has stepped down from his roles as CEO and chairperson but will continue to serve as an adviser for a year.
Linus’ Core Cognitive Evaluation tool estimates individuals’ risk of developing dementia and offers clinician guidance.
Fluid Biomed aims to make its polymer-based stent the next generation in the approach to vascular disease treatment.
The battery-free, single-incision, and leadless system represents a solution for adults suffering from moderate to severe OSA.
Neuralink owner Elon Musk shared a letter from his lawyer on the social media platform X detailing an “improperly motivated campaign”.
SQ Innovation will seek full US approval after the regulatory exclusivity period of a competing product elapses in October 2025.
The commercial availability of the system is expected in the first quarter of next year.
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