
ABILITY Neurotech receives MREC approval for ALS BCI clinical trial
The clearance enables ABILITY Neurotech to move beyond intra-operative testing to long-term clinical investigation involving human participants.

The clearance enables ABILITY Neurotech to move beyond intra-operative testing to long-term clinical investigation involving human participants.

Abbott (NYSE:ABT) announced today that it received CE mark approval for its dual glucose-ketone sensing technology for people with diabetes.

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the TOBY Alzheimer’s Test, a urine-based diagnostic test developed by TOBY, a biotechnology company based in Austin, Texas.

The CE certification confirms compliance with regulatory standards for safety, efficacy, and quality management.

Neurovalens announced today that it received FDA de novo approval for Modius Spero, a post-traumatic stress disorder (PTSD) therapy.

Cornerstone Robotics announced today that it received CE mark approval for its Sentire endoscopic surgical robotic platform.

Zimmer Biomet (NYSE:ZBH) announced today that it received FDA 510(k) clearance for an advanced version of its Rosa Shoulder System.

FDA Registration Accelerates Healium Clinical’s Expansion into Healthcare Settings Nationwide

The approval is expected to drive increased clinical adoption and support applications for regulatory approval in other markets.

Leo Cancer Care’s CE mark approval for Marie® signals a transformative shift in how radiotherapy is delivered across Europe.