The FDA sent an early safety alert warning clinicians of deployment failures with certain Boston Scientific AXIOS Stent and ...

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...

Zylox-Tonbridge Medical Technology Co., Ltd. ("Zylox-Tonbridge", HKEX: 2190) is a medical technology company dedicated to the innovative research and development, manufacturing and commercialization ...

Freedom of Information Act requests filed with the Food and Drug Administration by hedge funds last month revealed big financial players closely eyeing warning letters, enforcement documents, and ...

Medtronic said Monday it received 510 (k) clearance from the Food and Drug Administration for an app to connect its smart ...

The Naox Link system uses soft, biocompatible in-ear electrodes integrated into wired earbuds to acquire, record, and ...

The system aims to address underlying chronic cough and issues with mucus production and clearance in chronic bronchitis.

The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...

Johnson & Johnson’s filing comes a month after Medtronic gained U.S. clearance for its Hugo system as competition in the soft ...

FDA nonmedical wearable health data devices providing general health info will not face regulation, clarifying guidance for ...

The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.

FDA announces wearable devices providing non-medical info won't face regulation, offering clarity on digital health ...