AccurKardia, an innovator in ECG-based diagnostics technology, today announced that its AccurECG TM software platform has ...

Neuralink, Elon Musk's neurotechnology company, has achieved a significant milestone by receiving Breakthrough Device ...

RxDx Device is an immunohistochemistry (IHC) assay combined with a digital pathology algorithm to determine patient treatment ...

The Ventana TROP2 RxDx Device, a computational companion diagnostic, was granted breakthrough device designation by the FDA ...

CHENNAI: It’s nothing but the dance of mind and machine, where neurons whisper secrets and wires weave dreams. As the digital ...

Neuralink said on social media that it received FDA breakthrough device designation for treating individuals with severe ...

A new drug application seeking the approval of ziftomenib was submitted to the FDA on April 8, 2025. This indication is for ...

Orchestra BioMed’s hypertension treatment is the latest medical device to earn the FDA’s breakthrough designation. Medtronic has a commercialization deal with the company for the device ...

US FDA grants breakthrough device designation to Roche’s companion diagnostic, VENTANA TROP2 (EPR20043) RxDx Device for non-small cell lung cancer: Basel Wednesday, April 30, 20 ...

In 2024, AccurKardia received FDA Breakthrough Device Designations for two novel applications: “By pioneering these breakthrough ECG-based solutions, AccurKardia is redefining cardiac ...

RxDx Device for non-small cell lung cancer has received Breakthrough Device Designation from the U.S. Food and Drug ...