December Sees Surge in AI-Powered Medical Device Clearances 🔗
At Innolitics we keep a strong finger on the pulse of recent FDA AI/ML software related clearances. This is one of the many ways we maintain our FDA clearance and 3 month submission guarantees. The second half of December 2025 has been marked by a significant wave of innovation in the medical device industry, with the U.S. Food and Drug Administration (FDA) granting 15 new AI/ML software 510(k) clearances in just a nine-day period. This surge underscores the growing trust in AI to enhance clinical decision-making, improve patient outcomes, and streamline healthcare workflows.
The clearances span a diverse range of medical fields, with neurology and cardiology leading the way. The trend highlights a clear focus on leveraging AI to tackle complex diagnostic challenges in these areas, from detecting cardiac arrhythmias and atrial fibrillation to screening for delirium and enhancing stroke detection. The dental and sleep medicine sectors also saw multiple AI-powered innovations, indicating a broad-based movement towards integrating intelligent software in various clinical settings.
The body map above illustrates the diverse anatomical focus of these clearances. Neurology leads with five devices targeting brain health, followed by cardiology with three heart-focused innovations. Sleep medicine devices address airway and breathing disorders, while dental AI tools enhance oral diagnostics. Imaging devices extend to specialized applications like prostate assessment and carpal tunnel diagnosis, demonstrating the breadth of AI integration across medical specialties.
Below is a summary of the recent 510(k) clearances, providing a snapshot of the devices and technologies that are set to shape the future of medical care.
Recent 510(k) Clearances (December 10-18, 2025) 🔗
| Manufacturer | Device Name | Date | Indications for Use | Device Inputs | Device Outputs | Link |
|---|---|---|---|---|---|---|
| Clarius Mobile Health | Clarius Prostate AI | 2025-12-17 | Automatically identify the prostate and perform measurements to calculate prostate volume and PSA Density for urological assessments | Ultrasound images | Prostate identification, measurements, prostate volume, PSA Density calculations | Link |
| Clarius Mobile Health | Clarius Median Nerve AI | 2025-12-17 | Locate and measure the median nerve during Carpal Tunnel Syndrome assessments | Ultrasound images | Median nerve location and measurements | Link |
| Vektor Medical | vMap (Next-Generation) | 2025-12-10 | Non-invasive cardiac mapping for atrial flutter; transitioned to Software as a Medical Device (SaMD) model | ECG data | Cardiac mapping, arrhythmia source identification including atrial flutter | Link |
| Huxley Medical | SANSA (Diagnostic ECG) | 2025-12-18 | Diagnostic ECG monitor to detect cardiac arrhythmias (atrial fibrillation) during home sleep apnea testing | Single chest-worn patch ECG | Arrhythmia detection using AI-driven analysis | Link |
| Ceribell Inc. | Ceribell Delirium Monitoring Solution | 2025-12-18 | Screen for delirium in critical care patients | EEG data | Delirium screening notifications when patterns associated with delirium are detected | Link |
| Pearl Inc. | Second Opinion (Panoramic X-Rays) | 2025-12-18 | Detection of dental pathologies on panoramic radiographs | Panoramic radiographs | Identification and highlighting of suspected caries, periapical radiolucencies, and impacted third molars | Link |
| Overjet | Overjet CBCT Assist | 2025-12-16 | Analyze 3D Cone Beam Computed Tomography (CBCT) images to automatically identify, segment, and quantify anatomical structures for dental diagnostics | 3D CBCT images | Bone levels, airways, nerve canals identification and quantification | Link |
| mlHealth 360 | Scaida BrainCT-ICH | 2025-12-18 | AI-powered triage for detecting intracranial hemorrhage in non-contrast CT scans | Non-contrast CT scans | ICH detection and triage notifications | Link |
| SleepRes | Kricket PAP Device | 2025-12-17 | Sleep apnea therapy with adaptive pressure technology | Real-time breathing cycles | Dynamically adjusted therapy pressure using Kairos adaptive pressure technology | Link |
| HeartBeam | Cable-Free 12-Lead ECG Synthesis | 2025-12-10 | At-home arrhythmia assessment | 3-lead ECG signals | Synthesized 12-lead ECG using proprietary algorithms | Link |
| HeartSciences | MyoVista wavECG | Not cleared yet | Detect cardiac dysfunction using AI-ECG algorithms | ECG signals | Cardiac dysfunction detection | Link |
| CMR Surgical | Versius Plus | 2025-12-17 | Surgical robot with near-infrared fluorescence imaging for enhanced visualization | Surgical video feed | Near-infrared fluorescence imaging; integration with digital data platform for AI-ready analysis | Link |
| Huxley Medical | SANSA (Central Sleep Apnea) | 2025-12-17 | Central Sleep Apnea (CSA) detection on home sleep apnea test | Sleep apnea test data | Differentiation between central and obstructive apnea | Link |
| Hyperfine | Optive AI (Swoop System) | 2025-12-15 | Stroke detection using portable MRI with advanced diffusion imaging | MRI diffusion-weighted imaging (DWI) | Enhanced image quality and diagnostic confidence for stroke detection | Link |
| ResMed | Smart Comfort | 2025-12-18 | Personalized CPAP therapy settings recommendation | Patient sleep data | Personalized CPAP settings recommendations | Link |
| Medivis | Cranial Navigation Platform | 2025-12-16 | Intraoperative guidance in cranial neurosurgery | Medical imaging data | Augmented reality visualization for surgical guidance | Link |
This flurry of activity from the FDA demonstrates a clear commitment to advancing medical technology and embracing the potential of AI to revolutionize patient care. As these innovative devices enter the market, they promise to bring more accurate diagnostics, personalized treatments, and improved clinical efficiency to patients and providers alike.
