FDA Related News

Medical Devices

Bipartisan House Bill Would Eliminate Medical Device Tax

Bipartisan legislation is introduced in the House to permanently repeal the medical device excise tax.

Medical Devices

Elucent Breast Cancer Navigation Marker Cleared

FDA clears an Elucent Medical 510(k) for the EnVisio Surgical Navigation System to identify the location of the tissue to be removed.

Human Drugs

Takara Bio Files DMF for Liquid RetroNectin

Takara Bio files a Drug Master File to FDA for the liquid formulation of RetroNectin GMP grade.

Medical Devices

FDA Clears Ortho Clinicals Vitros XT MicroSlides

FDA clears an Ortho Clinical Diagnostics 510(k) for the Vitros XT MicroSlides, featuring new multi-test technology that allows labs to run two tests s...

Human Drugs

FDA Orders Addyi Safety Labeling Changes

FDA orders Sprout to make Addyi labeling changes to reflect agency concerns about women drinking alcohol when taking the hypoactive sexual desire diso...

Medical Devices

Dont Use Uncleared, Unapproved Devices for Concussion: FDA

FDA cautions against using unapproved or uncleared medical devices to diagnose, treat, or manage head injuries, including concussions.

Invidior Indicted for Illegal Suboxone Marketing

A federal grand jury indicts Invidior for illegal misleading marketing of its Suboxone Film opioid-addiction treatment.

Human Drugs

FDAs PHASE Characterizes New Opioids

CDER staffers describe the Centers new Public Health Assessment via Structural Evaluation being used to characterize new opioids as part of FDAs work ...

Medical Devices

Getinge 510(k) for Software Update to Ventilators

FDA clears a Getinge 510(k) for a new software version for the Servo-u and Servo-n mechanical ventilator platform.

Medical Devices

Avinger Small Vessel Atherectomy System Cleared

FDA clears an Avinger 510(k) for its Pantheris SV (Small Vessel) image-guided atherectomy system.