AZmed wins 6th FDA clearance, expanding AZchest on chest X-rays

Paris medtech AZmed said the FDA cleared AZchest to detect and localize pneumothorax, pleural effusion, consolidation, and increased cardiothoracic ratio on frontal chest radiographs — its sixth U.S. clearance. With earlier lung-nodule detection, AZchest now covers five chest findings on one image; the broader Rayvolve suite reaches eight cleared findings across musculoskeletal and chest X-rays.

A same-day company primary plus an FDA 510(k) record expands a chest X-ray AI helper to findings that change urgent care — collapsed lung, fluid, consolidation, and heart-size ratio — with multi-reader evidence the company says improves accuracy and speed.

AZmed, a Paris medical-technology company, announced its sixth U.S. Food and Drug Administration clearance for AZchest, AI software that looks for chest problems on frontal chest X-rays. That 15 Sep 2026 company news post is the filing event. These are company claims. This desk did not review the FDA letter.

Newly cleared findings, as the company lists them: pneumothorax, pleural effusion, consolidation, and increased cardiothoracic ratio. The software is cleared to detect and localize those findings — find them and mark where they are. In plain English: pneumothorax is an air leak that can collapse a lung; pleural effusion is fluid around the lung; consolidation is lung tissue filled in, often an infection or pneumonia pattern; cardiothoracic ratio is how wide the heart looks compared with the chest. File those four findings as the company’s. This is assist software, not a diagnosis on its own.

Together with lung-nodule detection, which the company says was cleared in March 2025, AZchest now covers five findings on a single image. The broader Rayvolve suite, the company says, now reaches eight FDA-cleared findings across musculoskeletal X-rays — bones, joints, and muscles — and chest X-rays. File five-on-one-image and eight-across-MSK-and-chest as AZmed’s. This desk is not ranking “broadest” offerings.

The FDA 510(k) database lists Device Name “Rayvolve AZchest,” 510(k) number K261378, applicant AZmed of Paris, decision date 28 Aug 2026, decision Substantially Equivalent (SESE). A 510(k) is the common FDA path that clears a device as substantially equivalent to something already on the market. The company’s public announce of this expansion is 15 Sep 2026 — that announce date is the news wire; 28 Aug 2026 is the FDA decision on the record. File the database line as the FDA’s.

Standalone study, company-attributed: 8,453 per-finding evaluations; area under the curve, or AUC, of 0.94 to 0.98 for all four findings. AUC is a detection-accuracy score from 0 to 1; closer to 1.0 is better. Per-image sensitivity 90.8% to 97.0%; specificity 87.9% to 92.1%. Sensitivity is how often the tool catches a finding that is there; specificity is how often it stays quiet when the finding is not. File those figures as AZmed’s study numbers — not an independent peer-reviewed trial endpoint unless a journal is named. The company post does not name a journal for this standalone run.

Multi-reader, multi-case study, still the company’s: 1,489 per-finding evaluations; 20 readers, including 10 thoracic radiologists — chest-imaging specialists. Readers first worked without the tool, then with AZchest after a one-month washout. Reader AUC rose from 0.88–0.89 unaided to 0.91–0.94 aided; the company says sensitivity and specificity also improved. Thoracic radiologists were up to 15.9% faster; readers from other specialties up to 31.0% faster. File those gains and time cuts as AZmed’s. This desk did not sit with the readers, and it is not treating the speed cuts as a miracle or a mortality result.

SimonMed, a U.S. outpatient imaging provider, provided the clinical data behind this clearance, the company said. The relationship dates to 2023. The company also says SimonMed data supported an earlier pediatric-fracture clearance. File the data source as AZmed’s. This desk did not audit SimonMed’s archive.

Julien Vidal, CEO of AZmed, quoted on the company post: “Radiologists should not need a different AI tool for every finding on the same image.” And: “We are building one suite that covers the X-ray, and every step of it carries strong clinical evidence.” File the quotes as his. They are not an independent product review, and they are not a claim the tool replaces radiologists.

Company about box: founded 2018; European MedTech; Rayvolve tools described as FDA-cleared and CE-marked; used by more than 2,500 healthcare facilities worldwide. File those lines as AZmed’s. This desk did not count the sites.

What this is not: AZchest is Class II computer-aided detection / assist software — a helper for clinicians reviewing chest X-rays, not autonomous diagnosis, not a drug approval, and not a claim it replaces radiologists or cuts deaths. Extra 510(k) numbers beyond K261378 are not invented here.

PRIMARY here: AZmed’s 15 Sep 2026 company news post — Tier A company source, not a second-hand wire — plus the FDA 510(k) Premarket Notification database record for K261378 (Rayvolve AZchest; decision 28 Aug 2026; SESE). The four newly cleared findings, the five-on-one-image / eight-across-MSK-and-chest counts, the standalone and multi-reader figures, the SimonMed data line, and the Vidal quotes are company-attributed. The device name, K261378, decision date, and SESE decision are the FDA’s. NOT claimed: extra 510(k) numbers, radiologist replacement, mortality cuts, a drug approval, independently peer-reviewed trial endpoints, that this desk reviewed the FDA letter, a stock tip, or investment advice. Distinct from the already-filed curvebeam-ai-fda-ct-bmd-510k, nvidia-chop-cardiac-monai, inductive-bio-indy-chemistry, and tandem-health-100m-series-b.