Biotech News

Accelerate Diagnostics Submits WAVE System and Gram-Negative Positive Blood Culture Menu to the FDA for 510(k) Clearance

Accelerate Diagnostics (AXDX)Accelerate Diagnostics2025-03-21 17:52 ESTFDA / regulatory

AXDX (AXDX) appears in the live feed after a catalyst-style update. The headline is surfaced in real time so readers can move from signal to source without leaving the product flow.

The source domain is axdx.com. BioPharmSignal keeps the ticker, timestamp, and source together for faster review before the wider market catches up.

The original release is available below in a new tab so readers can continue into the full source when needed.

Related news

INBSIntelligent Bio Solutions2026-09-09 12:30 EST

Intelligent Bio Solutions Submits FDA 510(k) Package for Intelligent Fingerprinting Drug Screening System, Seeking U.S. Market Clearance

INBSIntelligent Bio Solutions2026-06-02 12:30 EST

Intelligent Bio Solutions Commences Multi-Site Method Comparison Study for FDA 510(k) Submission

DGXQuest Diagnostics2026-08-24 11:24 EST

Quest Diagnostics to Offer FDA-Cleared Roche pTau217 Blood Test to Assess Alzheimer's Disease Pathology

DGXQuest Diagnostics2026-06-24 12:52 EST

Quest Diagnostics Receives New York State Approval for Haystack MRD®, Broadening Patient Access to ctDNA Minimal Residual Disease Testing

OSUROraSure Technologies, Inc.2026-06-11 12:00 EST

OraSure Technologies, Inc. Announces FDA Clearance that Expands Patient‑Friendly Access to Testing for Sexually Transmitted Infections

RHHBYRoche Holdings AG2026-10-16 05:00 EST

FDA approves Roche’s Enspryng, a first-in-class IL-6R inhibitor, as the first and only at-home subcutaneous treatment option for thyroid eye disease (TED)

RHHBYRoche Holdings AG2026-10-09 05:00 EST

FDA approves Roche’s Tecentriq in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of a certain type of stage III colon cancer

BDSXBiodesix2026-10-19 10:00 EST

Biodesix Adds Digital Diagnostics to Lung Pipeline, Creating New Growth Platform Combining Blood and Imaging Biomarkers

BJDXBluejay Diagnostics2026-08-13 10:00 EST

Bluejay Diagnostics Reports Q2 2026 Results; Strengthened Balance Sheet Supports Advancement of Symphony™ IL-6 Toward Regulatory Submission and Commercialization

LUCDLucid Diagnostics2026-11-05 13:25 EST

Lucid Diagnostics Recognized as a GenomeWeb Best Place to Work for Second Consecutive Year

View all latest news

Accelerate Diagnostics

Accelerate Diagnostics was a diagnostics company focused on rapid infectious-disease testing before its restructuring and decline. Its platform aimed to speed up bacterial identification and susceptibility testing.

Recent company news

AXDXAccelerate Diagnostics2025-05-08 13:00 EST

Accelerate Diagnostics Files for Chapter 11 Protection and Agrees to Terms to Sell Substantially All Assets

AXDXAccelerate Diagnostics2025-03-21 17:52 EST

Accelerate Diagnostics Submits WAVE System and Gram-Negative Positive Blood Culture Menu to the FDA for 510(k) Clearance

AXDXAccelerate Diagnostics2025-03-21 12:30 EST

Accelerate Diagnostics Reports Fourth Quarter and Full-Year 2024 Financial Results

AXDXAccelerate Diagnostics2025-01-10 21:05 EST

Accelerate Diagnostics Announces Certain Preliminary Fourth Quarter and Full-Year 2024 Results

AXDXAccelerate Diagnostics2024-11-07 21:05 EST

Accelerate Diagnostics Reports Third Quarter 2024 Financial Results

Stock data

Close: —
Market cap: —
Exchange: NASDAQ
Sector: MedTech
Location: United States