Neuralink and Cognixion are competing to revolutionize speech restoration through groundbreaking brain-computer interface ...

The US Food and Drug Administration (FDA) has awarded Neuralink’s brain-computer interface breakthrough device designation ...

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

Elon Musk announced plans to make Neuralink's brain-computer interface technology "widely available" following the company's ...

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 ...

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

The company said that its test could overcome sensitivity issues with ultrasound and serum alpha-fetoprotein assays that are used to monitor at-risk patients.

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

Roche has claimed a breakthrough designation from the FDA for a cancer test that combines an antibody assay with ...

The U.S. FDA granted breakthrough device designation to Mursla Bio Ltd.'s Evoliver. The biopsy blood test uses extracellular vesicles to survey hepatocellular carcinoma in high-risk cirrhotic patients ...

The FDA previously granted the Tango Belt "breakthrough device designation" in 2023, making it eligible for expedited review ...