Medical AI developers should select a single first regulatory claim — such as measuring a radiologist-selected pulmonary nodule on non-contrast chest CT — before funding validation, because each of fi…
The FDA granted De Novo request DEN250044 to Powerful Medical for its STEMI AI ECG Model, known as the Queen of Hearts, on September 3, 2026, creating new product code SHS with a predetermined change …
The FDA cleared a Class II AI device, K232613, on February 28, 2024, whose indications for use define the regulated device as a command line software application running on Ubuntu 20.04.5 LTS via Dock…
An analysis of all 1,483 AI/ML-flagged records in the Innolitics FDA Device Explorer found 88 AI software-as-a-medical-device clearances that cite a predicate which is not SaMD, and 50 of those are ca…
Limbic Inc.'s generative AI-enabled medical device Unpacked, which delivers CBT-based treatment via a voice agent for depression, is on the U.S. market under the FDA's TEMPO pilot, marking the first s…
A law firm specializing in AI-enabled software as a medical device reports that the FDA's device classification hinges on a product's intended use and claims, not its technology, and that the 21st Cen…
Innolitics partner David Giese, who has helped bring 35+ AI-enabled diagnostic devices to the US market, published a guide on FDA Pre-Submissions, noting that the FDA currently charges no fee for Pre-…
A new analysis of 1,483 FDA AI/ML device records finds that follow-on 510(k) clearances for AI medical devices require dramatically fewer new patients than the original De Novo authorizations, with di…
A new analysis by Innolitics of 890 FDA clearance letters for AI/ML software-as-a-medical-device authorizations through August 2026 finds that 57 percent name an in-house regulatory or quality person,…
The U.S. Food and Drug Administration (FDA) released a discussion paper on August 18, 2026, outlining potential regulatory approaches for generative AI-enabled medical devices, with comments due Octob…
One in five AI/ML 510(k) clearances cites a predicate under a different product code, with 85 devices predicated on a different body region, 35 swapping imaging modality, and 122 crossing 21 CFR regul…
The U.S. Food and Drug Administration (FDA) does not mandate a universal sample size for sensitivity and specificity studies, but its final 2025 guidance for AI-enabled device Predetermined Change Con…
On August 5, the U.S. Food and Drug Administration (FDA) named Cadence the second participant in its TEMPO pilot program for HypertensionOS, a software device that generates protocol-bound medication-…
The FDA named Dexcom the first participant in its TEMPO pilot on July 22, 2026, pairing real-world evidence collection with CMS's ACCESS payment model to support wearable diagnostic AI. Dexcom's devic…
FDA issued a warning letter to Nihon Kohden Digital Health Solutions on July 14, 2026, rejecting the company's decision to document a software update as a letter to file instead of submitting a new 51…
The U.S. Food and Drug Administration (FDA) has introduced Predetermined Change Control Plans (PCCPs) as a regulatory tool allowing companies to pre-clear certain device changes within a 510(k), De No…
The Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) published a Request for Information on July 16, 2026, reopening the question of whether AI d…
A consulting firm built a private benchmark of more than 1,200 FDA regulatory judgment questions and tested 18 frontier AI models, finding that every model failed the questions that carry the highest …
The FDA's January 2025 draft guidance on AI-enabled medical devices recommends that model descriptions detail inputs, outputs, architecture, training, and limitations, but the document remains draft a…
The FDA cleared 14 AI/ML-enabled medical devices in Q2 2026, including De Novos and 510(k)s, spanning neurology, cardiology, radiology, and other specialties. Key clearances include neuropacs' MSAp/PS…