Industry

Diagnostics

In vitro and companion diagnostics, screening tests and sensors: clearances, De Novo and breakthrough decisions, and advisory panels.

8 stories

All coverage

8 stories, newest first.

Search within Diagnostics coverage, or narrow it further.

Sections Agencies Series

Showing 8 of 8 stories

A paramedic in blue gloves holds an LVOne test cassette in front of a yellow NHS ambulance

Spotlight UpFront Diagnostics Earns CE Mark for Stroke Test Sep 17, 20265 min read Read the story

Two lab technicians in a clinical laboratory review blood sample vials and analyzer readouts

Devices & Diagnostics FDA Grants Nutromics' Patch Breakthrough Status Sep 11, 20264 min read Read the story

The Texas State Capitol dome against a clear blue sky, with the American and Texas flags flying from an adjacent rooftop

Devices & Diagnostics FDA Clears Abbott's Libre Duo Glucose-Ketone Monitor Aug 25, 20265 min read Read the story

Two masked lab scientists in white coats and safety goggles examine test tubes beside a microscope

Guidance & Policy FDA Eases Path for Cancer Companion Diagnostics Aug 19, 20265 min read Read the story

Two lab technicians in cleanroom garb examining a sample under a microscope in a bright diagnostics laboratory

Devices & Diagnostics FDA Sets a September Panel on GRAIL's Galleri Blood Test Aug 17, 20266 min read Read the story

Two gowned, hairnet-capped laboratory researchers examining a sample under a microscope, one adjusting her glasses to look into the eyepiece

Devices & Diagnostics FDA Grants Breakthrough Status to Freenome Lung Test Aug 16, 20265 min read Read the story

Two masked, gowned laboratory researchers in a cleanroom review a sample slide loaded on a light microscope

Devices & Diagnostics FDA Lets Proscia Add Scanners Without New 510(k)s Aug 6, 20265 min read Read the story

A gloved hand lifts a rack of purple-capped sample collection tubes at a testing table, with a rapid-test box in the background

Guidance & Policy FDA Gives Home COVID Tests a Permanent Class II Address Jul 27, 20265 min read Read the story