Peytant Solutions CEO John Schorgl explains how his device startup turned a complex FDA de novo application into a lasting ...

Vesalio announced two FDA 510(k) clearances for its aspiration devices for peripheral and neurovascular applications, ...

The FDA has cleared home use of a device that helps people with spinal cord injuries regain mobility and functioning.

An Upper Saucon Township company that specializes in surgical equipment will pay $38.5 million to settle allegations under ...

FDA Section 524B transformed medical device cybersecurity from guidance to law, challenging small medtech firms with ...

The US Food and Drug Administration (FDA) has granted 510(k) clearance for the expanded use of Onward Medical’s ARC-EX System ...

In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: Quality System ...

The smart thermometer performs a check-up on your body temperature, cardiac, and pulmonary health in less than a minute.

Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...

Pazdur replaces former Center for Drug Evaluation and Research Director George Tidmarsh, who exited the agency earlier this ...

Two Chicago-area medical device companies announced federal clearances for their respective spinal surgery devices.

The US FDA has granted 510(k) clearance, expanding the label of BrainsWay’s Deep Transcranial Magnetic Stimulation (TMS) ...