Kamen and Sequel Medtech CEO Alan Lotvin say they are offering greater precision in insulin delivery with new pump technology ...

SmartCardia announced today that it received FDA clearance for mobile outpatient cardiac telemetry (OCT/MCT) for its ECG ...

Andrew Simpson, CEO of HeartSciences, said, "The inclusion of AI-ECG for reimbursement by CMS represents a significant milestone for commercialization of our products and further validates the ...

FDA 510(k) Clearance Would Enable the Introduction of INBS’ Technology to the US in 2025 NEW YORK, Nov. 13, ...

(RTTNews) - GE HealthCare Technologies Inc. (GEHC) Wednesday said that it has received FDA 510(k) clearance for its innovative SIGNA MAGNUS 3.0T high-performance, head-only magnetic resonance imaging ...

The Chicago-based medical technology company said the MRI device, called Signa Magnus, had received 510(k) clearance by the U.S. Food and Drug Administration. That approval pathway is for devices that ...

Fourth Frontier has achieved a crucial milestone with the FDA's clearance of the Frontier X Plus, a single-lead ECG monitor. Positioned to enhance heart health monitoring, this wearable device ...

Fourth Frontier, a medical technology company based out of New York and Bangalore, announced the 510(k) clearance of the ...

Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared portable ...

Discover how Remedy Logic's FDA-cleared RAI program, powered by AI, is revolutionizing spine MRI interpretation for radiologists and patients.

The reelection of former President Donald Trump, coupled with Republicans gaining the Senate majority and poised to gain the House majority, ...