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

The company said that its applications can be extended to individuals affected by ALS, stroke, spinal cord injury, cerebral ...

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

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

The device is designed to lower blood pressure while simultaneously modulating the autonomic nervous system by delivering ...

The FDA designation is a step forward for Neuralink as owner Elon Musk faces increasing scrutiny. The US Food and Drug ...

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

The biotech company Roche is receiving support towards its efforts to advance cancer diagnosis and digital pathology ...

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