We’re here to keep you up to speed with the latest on FDA device approvals, regulatory updates, and emerging adverse event trends. Each edition is designed to give you clear, actionable insights—so you can stay informed, proactive, and ahead in the evolving landscape of medical device regulation.
Let’s take a look at what’s new this month.
New Device Approvals/Clearances
In July 2025, the FDA approved 1 De Novo device with a review time of 248 days, 4 PMA devices averaging 269 review days, and cleared 282 devices via the 510(K) pathway with an average review time of 144 days. Below, we spotlight the groundbreaking technologies that have successfully advanced through the regulatory process:
- Oncomine Dx Express Test (P240040) – 232 review days
The FDA approved the Oncomine™ Dx Express Test on the Ion Torrent™ Genexus™ Dx Integrated Sequencer as an in vitro diagnostic assay for use as a companion diagnostic for sunvozertinib (Zegfrovy) in EGFR exon 20 insertion mutation–positive non–small cell lung cancer (NSCLC) and for use in tumor profiling. The Oncomine Dx Express Test is also indicated for tumor profiling in solid tumors and the detection of cancer mutations with evidence of clinical significance and potential clinical significance across 46 genes. The tumor profiling approval allows for rapid next-generation sequencing (NGS) in a decentralized clinical setting, with results produced in as little as 24 hours.
- SetPoint System (P240039) – 268 review days
The FDA approved the SetPoint System, a neuroimmune modulation device, for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response, loss of response or intolerance to 1 or more biological or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs). The SetPoint System consists of a neurostimulation device that is surgically placed under general anesthesia on the vagus nerve. The approval of the SetPoint System was supported by data from the randomized, double-blind, sham-controlled, phase 3 REST-RA trial (NCT04539964), which included 242 patients, 60% of whom had difficult-to-treat RA.
- ArteraAI Prostate (DEN240068) – 248 review days
The FDA granted De Novo authorization for ArteraAI Prostate, establishing it as the first and only AI-powered software authorized to prognosticate long-term outcomes for patients with non-metastatic prostate cancer. This De Novo authorization establishes a new product code (SFH) for future AI-powered digital pathology risk-stratification tools and enables its implementation at the point of diagnosis at qualified pathology labs in the US.
- FDA cleared 20 AI/ML-enabled devices through the 510(K) pathway, including 16 Radiology devices, 1 Neurology device, and 3 Cardiovascular devices.
| Device ID | Device Name | Product Code | Medical Specialty | Decision Date | Company Name |
|---|---|---|---|---|---|
| K243341 | Genius AI Detection 2.0 | QDQ | Radiology | 7/31/2025 | Hologic, Inc. |
| K243919 | Voxel Dosimetry (00859873006226) | QIH | Radiology | 7/30/2025 | HERMES MEDICAL SOLUTIONS AB |
| K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | QYE | Cardiovascular | 7/28/2025 | ANUMANA, INC. |
| K251322 | Venue; Venue Go; Venue Fit; Venue Sprint | IYN | Radiology | 7/25/2025 | General Electric (GE) |
| K251455 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | IYN | Radiology | 7/24/2025 | Philips |
| K243681 | Neuro Insight V1.0 | LLZ | Radiology | 7/23/2025 | OLEA MEDICAL |
| K250686 | GyriCalc (Version 1.0.0) | LLZ | Radiology | 7/22/2025 | NEUROSPECTRUM INSIGHTS CORP. |
| K250901 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | LNH | Radiology | 7/22/2025 | Canon |
| K250999 | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System | IYN | Radiology | 7/18/2025 | Samsung |
| K250902 | HeartFlow Analysis | PJA | Cardiovascular | 7/18/2025 | HeartFlow, Inc. |
| K251839 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | KPS | Radiology | 7/17/2025 | Shanghai United Imaging Healthcare Co., Ltd. |
| K243547 | uMR Ultra | LNH | Radiology | 7/17/2025 | Shanghai United Imaging Healthcare Co., Ltd. |
| K243397 | uMR 680 | LNH | Radiology | 7/16/2025 | Shanghai United Imaging Healthcare Co., Ltd. |
| K250119 | Tempus ECG-Low EF | QYE | Cardiovascular | 7/15/2025 | TEMPUS AI, INC. |
| K251766 | TumorSight Viz | QIH | Radiology | 7/8/2025 | SIMBIOSYS, INC. |
| K243884 | TAVIPILOT | OWB | Radiology | 7/7/2025 | CARANX MEDICAL |
| K243679 | MammoScreen (4) | QDQ | Radiology | 7/3/2025 | THERAPIXEL |
| K250221 | StrokeSENS ASPECTS Software Application | POK | Radiology | 7/1/2025 | Circle Cardiovascular Imaging |
| K250096 | Felix NeuroAI System | QBC | Neurology | 7/1/2025 | FASIKL INCORPORATED |
| K243779 | Bunkerhill Abdominal Aortic Quantification (AAQ) | QIH | Radiology | 7/1/2025 | BUNKERHILL, INC |