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Diagnostics

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

42 stories

Regulatory News has published 42 Diagnostics stories between 27 July 2026 and 2 November 2026, each sourced to the primary record — the Federal Register entry, the Official Journal notice, the guidance document or the regulator’s own release — and written and edited by Connor Griggs, the publication’s editor. Last updated 2 November 2026.

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42 stories, newest first.

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Showing 42 of 42 stories

A physician in a white coat talks with a patient across a desk with pill bottles between them For Physicians FDA Moves a Targeted Combo Earlier in Prostate Cancer Nov 2, 20269 min read Read the story The AVITI Dx benchtop sequencer in front of a glowing network map of Europe, from Element Biosciences' launch banner Spotlight Element Biosciences Launches CE-Marked AVITI Dx Nov 1, 20266 min read Read the story NeuroDR's patient-specific 3D model of the head and neck arteries, in pale pink against a navy background Spotlight Deep Reasoning AI Secures FDA Clearance for NeuroDR Oct 30, 20267 min read Read the story A laboratory scientist in blue gloves touches the screen of a cobas smart e analyser while a colleague looks on Spotlight Roche Wins CE Mark for cobas smart e Immunoanalyser Oct 30, 20267 min read Read the story A team reviewing a product rollout around a conference table with laptops open Devices & Diagnostics FDA Clears Sekisui's OSOM COVID-19/Flu Combo Test Oct 28, 20265 min read Read the story A gloved clinician holds the EsoCheck cell-collection device with its balloon inflated Spotlight Lucid Begins Medicare Payment for EsoGuard DNA Test Oct 27, 20267 min read Read the story A gloved scientist working inside a biosafety cabinet with petri dishes in a clinical microbiology lab, a generic stand-in for bioMérieux’s diagnostics work Devices & Diagnostics FDA Clears bioMérieux’s Point-of-Care Vaginitis Panel Oct 27, 20265 min read Read the story RIVANNA's handheld Accuro ultrasound device scanning a patient's lower back Spotlight RIVANNA Wins FDA Clearance for BoneEnhance AI Oct 26, 20266 min read Read the story An axial chest CT slice through the heart and descending thoracic aorta, from Coreline Soft's Aorta Metrics product page Spotlight Coreline Soft Wins 13th FDA Clearance for Aortic AI Oct 24, 20266 min read Read the story A smiling executive in a pink jacket at a city office window, standing in for SimBioSys's leadership announcing the TumorSight Risk clearance For Physicians FDA Clears AI Tool to Score Breast Cancer Recurrence Oct 21, 20269 min read Read the story Rendering of Sensydia's Cardiac Performance System: acoustic sensors wired across a man's chest beside a tablet showing a completed measurement Spotlight Sensydia Lands $6M to Push Heart Monitor to FDA Oct 20, 20266 min read Read the story Five panelists seated before a SimBioSys-branded screen at the company's October 2026 breast cancer care panel in Phoenix Spotlight SimBioSys Earns FDA Clearance for TumorSight Risk Oct 18, 20266 min read Read the story A businessman in glasses and a grey suit smiles in an office, with data charts pinned to the wall behind him Devices & Diagnostics WHO Expands Device Prequalification to Condoms, IUDs Oct 14, 20266 min read Read the story Two colleagues review a printed chart of data together at a conference table Devices & Diagnostics FDA Grants Breakthrough Status to Natera Cancer Test Oct 12, 20265 min read Read the story Lab staff push a sample cart through a bright cleanroom corridor Spotlight Sava Lands $36M Series B Led by Ascensia Oct 11, 20266 min read Read the story Two researchers in a bright teaching lab examine results together at a microscope station Spotlight Wellysis Wins FDA Clearance for S-Patch CardioAI Oct 11, 20266 min read Read the story Illustration of a clinician with a clipboard observing a young boy drawing at a small table Spotlight Argus Cognitive Earns FDA Clearance for Neurora Oct 10, 20265 min read Read the story A colleague gestures toward a whiteboard while briefing a seated team Guidance & Policy FDA Eases 510(k) Rule for Federal Drug-Test Devices Oct 9, 20266 min read Read the story A clinician in scrubs consults with a patient beside a bedside monitor Guidance & Policy FDA Finalizes Class II Rule for Hyperoxia Monitors Oct 9, 20266 min read Read the story A physician in a white coat positions a patient at the entrance of an MRI scanner For Physicians FDA Clears AI to Quantify Liver, Visceral Fat on MRI Oct 7, 202610 min read Read the story Two colleagues shake hands outdoors against a bright sky Guidance & Policy FDA Opens a 510(k) Path for Cancer Gene Panels Oct 7, 20265 min read Read the story Two colleagues shake hands in a bright office For Physicians FDA-Cleared Sepsis Panel Now Flags Resistance Genes Oct 6, 20268 min read Read the story A clinician in a white coat smiling while checking a phone beside an open laptop in a bright office Spotlight AIRS Medical Clears FDA 510(k) for Body-Fat MRI AI Oct 6, 20267 min read Read the story Three clinicians reviewing an imaging study together beside a bright window Spotlight VB Spine Wins FDA Breakthrough Nod for Scoliosis Blood Test Oct 2, 20267 min read Read the story A lab professional in a blue cardigan reviewing results on a laptop in a bright office walkway Spotlight QIAGEN Completes US Sepsis Panel Duo With FDA Clearance Oct 1, 20266 min read Read the story A clinician in a white blouse reviews data on a monitor in a bright white office Devices & Diagnostics FDA Clears Ceribell's New EEG Monitoring Tools Oct 1, 20266 min read Read the story Three colleagues review notes and laptops together in a bright white meeting room Spotlight CapsoVision Clears FDA for AI-Assisted Capsule Endoscopy Sep 29, 20267 min read Read the story A physician in a white coat and stethoscope reviews a tablet with a patient during a clinic consultation For Physicians FDA Approves Oral SERD Combo for ESR1+ Breast Cancer Sep 28, 20268 min read Read the story Two women in an office embrace and laugh together in celebration Spotlight Marani Health Clears FDA for M•care Fetal Monitor Sep 27, 20267 min read Read the story A scientist in a white lab coat and blue nitrile gloves works with sample vials in a cleanroom Spotlight Biolinq's Shine Clears FDA for OTC Sale Sep 26, 20266 min read Read the story Colleagues around a conference table lean in as one reviews a document, in the middle of a close discussion Devices & Diagnostics FDA Panel Narrowly Backs GRAIL's Galleri Test Sep 25, 20266 min read Read the story A team reviews charts and dashboards on a laptop screen and printed reports during a data review meeting Devices & Diagnostics FDA Grants Second Breakthrough Nod to UTI Test Panel Sep 23, 20265 min read Read the story A researcher in a lab coat examines a sample closely, in profile, under laboratory lighting Spotlight Koning Health Wins TGA Approval for Breast CT System Sep 21, 20266 min read Read the story A scientist in a white lab coat, blue gloves and safety glasses looks through a microscope in a laboratory Drugs & Biologics FDA Approves Lilly's Inluriyo-Verzenio Combo Sep 20, 20266 min read Read the story 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