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

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

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

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

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

EvoLiver, a blood test that detects early-stage liver cancer with high accuracy, has gained breakthrough device designation ...

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 ...

The device helps identify NSCLC subjects who are likely to benefit from Daiichi Sankyo and AstraZeneca’s Datroway’s treatment ...

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

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

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