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

Beacon Biosignals and Takeda have expanded their collaboration to progress narcolepsy diagnosis and the discovery of ...

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

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

Zimmer Biomet has received 510(k) clearance from the US Food and Drug Administration (FDA) for ROSA Knee with OptimiZe ...

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

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

The Eastern Military Region foiled a drug smuggling attempt early Thursday after spotting balloons loaded with narcotics and guided by primitive devices along its border. Border Guard forces tracked ...

Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...

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

The U.S. DOJ announced that B. Braun subsidiary Aesculap agreed to pay $38.5 million to resolve allegations under the False ...

INSYTE marks the first FDA-approved clinical trial of an intravascular optical imaging system designed specifically for the neurovasculature. The Spryte n OCT Imaging System uses high-resolution ...