FDA

11 items across 10 editions. First seen Sat 12 Sep, last seen Wed 28 Oct. Traced across 1 weekly review.

How this story has evolved

From the week in review: the connections, developments and open questions filed under FDA, newest week first.

Week of 19–25 October 2026

Development · Tue 20 Oct, Wed 21 Oct, Thu 22 Oct, Fri 23 Oct

Two FDA-cleared pulmonary embolism models fall below their clearance sensitivity across 67,869 scans as the FDA says it will write generative-AI device policy

A study published in npj Digital Medicine on 21 October evaluated "two FDA-cleared AI algorithms from a single commercial platform (Aidoc Medical BriefCase)-one for PE triage on dedicated CT pulmonary angiography (CTPA; n = 30,678) and one for incidental PE (iPE) detection on routine contrast-enhanced CTs (n = 37,191), across a 17-facility academic health system". "The PE model achieved 86.8% sensitivity and 99.1% specificity, with sensitivity declining from 99.3% for saddle emboli to 72.9% for subsegmental PE, and from 89.7% for acute to 65.3% for non-acute PE." "The iPE model achieved 73.5% sensitivity and 99.8% specificity." The authors conclude that "Both models demonstrated lower sensitivity than FDA-clearance benchmarks while exceeding cleared specificity, with diminishing performance for peripheral and non-acute emboli mirroring known human reader limitations and underscoring the need for standardized post-market surveillance of AI-enabled medical devices." Reference labels were extracted from radiology reports "using a validated LLM pipeline (97% accuracy, κ = 0.94)". The abstract names the two algorithms only by function and states no clearance benchmark value for either.

Wednesday, 28 October 2026

FDA clears Deep Reasoning AI's NeuroDR for neurovascular CT angiography, 105 days after submission beneficialSingle source

Medical Device Network

Deep Reasoning AI received FDA 510(k) clearance K262134 for NeuroDR, its first FDA-cleared product, 105 days after submission. The software runs automatically once a neurovascular CT angiography scan completes, removes soft tissue, bone and veins, and sends 3D views of the left and right internal carotid and vertebral arteries to hospital imaging systems as DICOM images.
The reported use is to help verify whether physician-identified lesions are present, and to help evaluate, document, monitor and plan treatment — a visualisation aid rather than a detection or diagnostic claim.
No performance data accompanies the clearance in the available reporting: the report says 3DR Labs conducted the performance studies and Innolitics designed them, but gives no endpoints, results or sample sizes, and quotes no formal indication statement. Only one outlet reported it, and the FDA's own AI-Enabled Medical Device List had not been updated to include it.

FDA Healthcare Incidents

Wednesday, 21 October 2026

Two FDA-cleared pulmonary embolism models fell below clearance sensitivity across a 17-facility health system mixed

npj Digital Medicine

Published 21 October in npj Digital Medicine, the study retrospectively evaluated two FDA-cleared algorithms from one commercial platform (Aidoc Medical BriefCase) across a 17-facility academic health system — PE triage on dedicated CT pulmonary angiography (n = 30,678) and incidental PE detection on routine contrast-enhanced CTs (n = 37,191). "The PE model achieved 86.8% sensitivity and 99.1% specificity" and "[t]he iPE model achieved 73.5% sensitivity and 99.8% specificity."
Performance fell sharply on the harder cases: sensitivity declined "from 99.3% for saddle emboli to 72.9% for subsegmental PE, and from 89.7% for acute to 65.3% for non-acute PE."
The authors write that "[b]oth models demonstrated lower sensitivity than FDA-clearance benchmarks while exceeding cleared specificity," and say this underscores "the need for standardized post-market surveillance of AI-enabled medical devices" — a gap the FDA is currently consulting on.
Reference-standard labels were extracted from radiology reports "using a validated LLM pipeline (97% accuracy, κ = 0.94)" rather than by independent image review, and the paper notes the drop on peripheral and non-acute emboli mirrors known human reader limitations. Aidoc provided the aggregated prediction outputs but, the acknowledgements state, had no role in study design, analysis, interpretation or manuscript preparation.

Healthcare FDA Evals

FDA digital health director says the agency will draft generative-AI device policy, after more than 300 comments Update

MedCity News·Becker's Hospital Review

Speaking on a panel at AdvaMed's MedTech Conference in Boston on Tuesday, Rick Abramson, director of FDA's Digital Health Center of Excellence, said of the agency's August generative-AI discussion paper: "So let me just say very directly, we intend to go to policy." MedCity News reports the comment period closed on Monday with more than 300 comments received, and that Abramson said draft policy guidance should be expected on the course of months.
Abramson framed the evaluation problem as unlike a conventional device: he said FDA floated the idea that "maybe these devices are starting to behave a little bit more like me as a physician" — assessed on clinical judgment and safety boundaries rather than exhaustively tested — because for generative AI "we have this unbounded evaluation space."
Becker's reports that in an October 19 letter to CDRH Director Michelle Tarver, the American Hospital Association said "vendors and developers must be responsible for the ongoing performance, maintenance and integrity of the tools they market," and cited an AHA survey finding "74% of hospitals have multiple teams responsible for evaluating predictive AI."
Nothing is in force: this is a stated intention to draft guidance, with no proposed rule text, no date and no legal effect yet. The closing of the comment window was covered in yesterday's edition; the new fact is the commitment to policy and the comment count.

FDA Healthcare US Federal Policy

Tuesday, 20 October 2026

FDA comment window on generative-AI medical devices closes with hospitals and the US Chamber split on scope

American Hospital Association·US Chamber of Commerce

Comments closed on the FDA's discussion paper on regulating generative-AI-enabled medical devices (docket FDA-2026-N-7874). The American Hospital Association backed a flexible, risk-based framework, asked the FDA to refine its proposed risk heuristic, and asked it to issue labelling guidance distinguishing "informational action directing" devices from "action taking" devices.
The AHA also asked the agency to align premarket clearance with post-deployment monitoring under a total product lifecycle, and to clarify that generative-AI clinical decision support and administrative tools are not subject to FDA oversight — a request that would put a large class of hospital AI outside the agency's reach.
The US Chamber of Commerce warned that "FDA should avoid allowing a high-level risk characterization to operate as a de facto new classification system", argued that "foundation-model 'safety' and medical-device safety and effectiveness are distinct concepts", and said that on agentic AI "it is premature to build a formal framework before the technology and its clinical applications are better understood".
The Chamber also proposed a voluntary "National Clinical AI Sandbox" run by HHS with state participation, allowing organisations to deploy autonomous clinical AI under phased clinician oversight. These are comments, not decisions; the FDA has not said what it will do.

FDA Healthcare US Federal Policy

Friday, 16 October 2026

SimBioSys says FDA cleared TumorSight Risk, an MRI-derived breast cancer recurrence risk tool, under 510(k) beneficialCompany claim

SimBioSys

The company says TumorSight Risk estimates individualised 5- and 10-year recurrence risk from pre-treatment breast MRI plus pathology and clinical data, for adult women with HR-positive, HER2-negative, Stage I-IIIA breast cancer, outputting a 0-100 score with low, intermediate and high categories.
Validation was a retrospective, multi-institutional, blinded study of 2,129 patients at Mayo Clinic, Emory University, Stanford Medicine and Mercy Medical Cedar Rapids, presented at the 2026 ASCO Annual Meeting.
The release reports high-risk patients had 3.3-fold higher recurrence risk than low-risk patients, each 10-point score increase was associated with a 22% increase in relative recurrence risk, 5-year recurrence ranged from 2.2% (scores 0-10) to 13.6% (scores 58-100), and 10-year recurrence from 6.2% to 34.2%, with the association holding after adjusting for stage, grade, age, race and treatment (p=0.002).
The figures come from the company's own release, which notes Mayo Clinic has a financial interest in SimBioSys. The release does not report sensitivity, specificity, or any comparison against existing genomic assays, and the validation was retrospective.

Healthcare FDA Drug Discovery

Tuesday, 6 October 2026

61% of authorised AI pathology diagnostic devices have no publicly available performance evidence, review finds mixed

npj Digital Medicine

The analysis identified "77 CE-marked or FDA-authorized AI/ML-based IVD software devices from 29 manufacturers, including 68 digital pathology and 9 hematology morphology devices", searched across FDA databases, EUDAMED, PubMed, Google Scholar, manufacturer portfolios and conference proceedings. It reports: "Publicly available device-specific performance evidence was identified for 30 devices (39%), while 47 devices (61%) had no identified publicly available performance evidence."
Evidence availability was "higher among devices with dual EU and USA authorization than EU-only devices (8/8, 100% vs 22/69, 32%; p < 0.001), and among hematology morphology devices than digital pathology devices (7/9, 78% vs 23/68, 34%; p = 0.02)". The authors found "15 distinct performance metrics" in use, with variation that limits direct cross-device comparison.
The authors note that "performance evaluation results do not require publication", and conclude their findings "indicate a gap between evidence availability and regulatory authorization" that "may undermine confidence in innovative medical devices and hinder informed clinical adoption". The study measures what is public, not whether the devices work.

Healthcare FDA Evals EU AI Act

Saturday, 3 October 2026

FDA device centre puts AI-device lifecycle and generative-AI mental-health guidances on its FY2027 A-list Update

FDA·MedTech Dive

MedTech Dive reports that the A-list in CDRH's fiscal 2027 guidance agenda includes a final guidance on marketing submissions and lifecycle management for AI-enabled devices, and a draft guidance on generative AI for conversational devices for mental disorders.
The FDA page itself says comments are due by 30 November 2026 to docket FDA-2012-N-1021, and that in FY2026 the centre published 7 of the 11 guidances on its list — 5 from the A-list and 2 from the B-list. That completion rate is the measure of what an A-list placement is worth.
A final AI lifecycle guidance would close out a draft issued in January 2025, and a generative-AI mental-health device draft would be the agency's first on chatbots used for mental health conditions.
The FDA page's own lists live in a downloadable PDF we did not open, so the two AI entries above come from MedTech Dive, not from the agency's text. The page is marked content-current as of 1 October, just before this window; the trade reporting is dated 2 October but carries no time of day. MedTech Dive's A-list counts (7 final, 1 draft) differ from another trade outlet's totals, so we report only the items, not the totals.

FDA Healthcare US Federal Policy

Tuesday, 29 September 2026

CapsoVision says FDA cleared AI Highlights, a lesion-flagging tool for small bowel capsule endoscopy beneficialCompany claimSingle source

CapsoVision (GlobeNewswire)

CapsoVision says AI Highlights, its AI-assisted reading tool for the CapsoCam Plus system, "received clearance from the U.S. Food and Drug Administration (FDA) on September 25, 2026".
The company says the tool is intended "to support physicians in the review of small bowel capsule endoscopy studies collected from adult and pediatric patients (over two years of age) in whom the study was performed due to suspected small bowel bleeding, specifically to reduce the time taken to review capsule endoscopy images", by marking images containing suspected abnormal lesions for prioritised review.
CapsoVision states the tool "is intended to be used by trained healthcare professionals and is not intended to replace gastroenterologists' diagnostic interpretation or, where applicable, histopathological sampling". The release reports no sensitivity, specificity or reading-time figures from the clearance submission, and chief executive Johnny Wang says the US clearance follows an international launch earlier this year including in the European Union.

FDA Healthcare Incidents

Tuesday, 22 September 2026

FDA issues direct final rule replacing "animal test" terminology and opens a database of non-animal method uses

FDA·Federal Register

The FDA release, dated 21 September 2026, says the direct final rule "updates its regulations to clarify that non-animal methods can be used where appropriate for testing the safety of drugs and biological products intended for human use before they're tried in humans", replacing "animal tests" and "animal studies" with "nonclinical tests" and "nonclinical studies", along with "preclinical" and "in vitro".
The FDA says it "also launched a database featuring specific uses of New Approach Methodologies (NAMs)", whose "initial release includes 25 examples drawn from publicly available FDA review materials" — including, per the release, methods using human cells, organs-on-chips and computer models.
Acting FDA Commissioner Kyle Diamantas is quoted: "This new rule supports the Trump Administration's push to explore ways to complement, or where appropriate, replace animal studies with methods that may better predict how medicines will actually affect people."
The FDA states the rule "does not eliminate or prohibit animal studies, change evidentiary standards or impose new costs or requirements on drug developers", and says it will withdraw the direct final rule if it receives significant adverse comments. This is terminology and a catalogue, not a validation standard for computational models.

FDA Drug Discovery US Federal Policy Healthcare

Friday, 18 September 2026

FDA final order denies Harrison.ai petition, keeping radiology CAD and triage AI software under 510(k) review

Federal Register (FDA)·Federal Register (full text)

FDA published a final order on 17 September (91 FR 58817–58819, Docket No. FDA-2025-P-5560) setting out its determination on a petition to exempt four radiology AI device types from premarket notification. "DATES: This order is effective September 17, 2026."
The order states FDA "determined that the information presented in the petition does not demonstrate that premarket notification is not necessary to assure the safety and effectiveness of the Subject CAD and CADt Devices", and that "Manufacturers of the Subject CAD and CADt Devices must continue to submit and receive FDA clearance of a 510(k) submission before marketing their devices".
The petition was filed on 22 October 2025 by Nancy Stade of Rubrum Advising on behalf of Harrison.ai. It covered radiological computer-assisted diagnostic software for lesions suspicious of cancer (§892.2060, product code POK), medical image analyzers (§892.2070, MYN), radiological computer aided triage and notification software (§892.2080, QAS and QFM) and radiological computer-assisted detection and diagnosis software (§892.2090, QBS and QDQ). It would have exempted a manufacturer that already held a clearance in the same regulation and implemented "a robust post-market plan, transparency, and training measures".
FDA denied the petition by letter on 1 April 2026, within the 180-day deadline; this order publishes that denial. The order adds that FDA "supports the continued consideration of innovative and least burdensome approaches", so the decision rejects this proposal rather than the idea of a lighter pathway.

FDA Healthcare US Federal Policy Evals

Saturday, 12 September 2026

FDA clears Omniscient's Quicktome Deep Brain for mapping brain networks in deep brain stimulation planning Company claim

Omniscient (GlobeNewswire)

Omniscient announced on 11 September at 14:42 ET that Quicktome Deep Brain (DB) has received 510(k) clearance from the FDA, its third clearance.
The company says the workflow localises leads, segments deep brain structures and maps white matter tracts within brain networks, for deep brain stimulation used in Parkinson's disease, essential tremor, dystonia and other movement disorders.
The release states roughly 10,000 new DBS procedures are performed in the US each year — the scale against which any benefit would be measured.
CEO Stephen Scheeler is quoted: "This is our third FDA clearance, and each one advances the same strategy: build the connectomic platform that becomes the standard across neuroscience care." A 510(k) clearance establishes substantial equivalence to a predicate device, not clinical benefit; the release reports no outcome data.

FDA Healthcare