Archive

Lumify Diagnostic Ultrasound System — Philips Ultrasound, LLC (FDA K252558)

Portable ultrasound with AI guidance can aid bedside diagnosis in India, improving access in rural and emergency settings.

Radiology · FDA — AI/ML-Enabled Medical Devices · 5 May

MammoSightAI — Neurocareai, Inc. (Dba Savelife.Ai) (FDA K252954)

This AI tool may assist you in mammography interpretation, potentially improving detection accuracy and workflow efficiency in breast screening.

Radiology · FDA — AI/ML-Enabled Medical Devices · 4 May

ArteraAI Breast — Artera, Inc. (FDA K254115)

This AI tool may help you personalize breast cancer treatment decisions by providing prognostic/predictive insights from pathology slides.

Oncology · FDA — AI/ML-Enabled Medical Devices · 4 May

Capnostream™35 Portable Respiratory Monitor (PM35MN) — Covidien, LLC (FDA K253030)

Portable capnography clearance gives anaesthesiologists a validated option for continuous ventilation monitoring outside the OR, aiding early detection of hypoventilation.

Anaesthesiology · FDA — AI/ML-Enabled Medical Devices · 1 May

Intelligent NR — Canon, Inc. (FDA K252503)

Canon's AI noise reduction may improve image quality at lower doses, potentially reducing radiation exposure in your patients.

Radiology · FDA — AI/ML-Enabled Medical Devices · 30 Apr

Synapse 3D Base Tools (V7.2) — Fujifilm Corporation (FDA K254189)

FDA clearance for Synapse 3D Base Tools V7.2 means you can deploy this imaging software in practice, but no new clinical capability is described.

Radiology · FDA — AI/ML-Enabled Medical Devices · 30 Apr

Bayesian Health Sepsis Flagging Device — Bayesian Health, Inc. (FDA K250680)

An AI sepsis flagging tool cleared by FDA can help you catch deterioration earlier on general wards, prompting timely intervention.

General Medicine · FDA — AI/ML-Enabled Medical Devices · 30 Apr

DeepHealth ProstateAI — Quantib B.V. (FDA K253682)

Adds an FDA-cleared AI tool for prostate MRI interpretation, potentially reducing false positives and improving biopsy decisions in your practice.

Radiology · FDA — AI/ML-Enabled Medical Devices · 29 Apr

syngo Application Software — Siemens Medical Solutions USA, Inc. (FDA K254184)

This FDA clearance lets Siemens' syngo software be used in US radiology practice, expanding access to AI-assisted imaging workflows for Indian clinicians adopting similar tools.

Radiology · FDA — AI/ML-Enabled Medical Devices · 29 Apr

CASSIE — Wesper, Inc. (FDA K252628)

An AI-enabled device cleared for anesthesia use—check if it aids monitoring or ventilation decisions in your OR.

Anaesthesiology · FDA — AI/ML-Enabled Medical Devices · 27 Apr

OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) — ABBOTT MEDICAL (FDA K253459)

For interventional cardiologists, this clearance expands AI-guided OCT imaging options, potentially improving stent placement accuracy and reducing procedural complications.

Cardiology · FDA — AI/ML-Enabled Medical Devices · 24 Apr

Lunit INSIGHT MMG (v1.1.10) — Lunit, Inc. (FDA K260320)

Adds an AI second reader for mammograms; may improve cancer detection and reduce recall rates in your screening workflow.

Radiology · FDA — AI/ML-Enabled Medical Devices · 23 Apr

DS Core CBCT Anatomy — Dentsply Sirona (FDA K260785)

AI auto-segments CBCT anatomy, saving you contouring time and improving consistency in dental and maxillofacial imaging.

Radiology · FDA — AI/ML-Enabled Medical Devices · 23 Apr

EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) — Ever Fortune.Ai, Co., Ltd. (FDA K253163)

AI tool flags appendicitis on CT; may help you triage equivocal scans faster and reduce missed cases in emergency radiology.

Radiology · FDA — AI/ML-Enabled Medical Devices · 22 Apr

uOmnispace.MR — Shanghai United Imaging Healthcare Co., Ltd. (FDA K253077)

An AI-enabled MR tool cleared for radiology use; check if your scanner integrates it to streamline workflow.

Radiology · FDA — AI/ML-Enabled Medical Devices · 22 Apr

myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) — Otto Bock Healthcare Products GmbH (FDA K253256)

For clinicians managing amputees, this cleared myoelectric system offers more intuitive prosthetic control, potentially improving functional outcomes and patient satisfaction in daily use.

Neurology · FDA — AI/ML-Enabled Medical Devices · 22 Apr

Folliscan — Mim Fertility (FDA K252332)

Automates follicle tracking on ultrasound, saving you time in fertility scans and improving consistency in monitoring.

Radiology · FDA — AI/ML-Enabled Medical Devices · 20 Apr

Novasight Hybrid System — Conavi Medical, Inc. (FDA K252945)

Gives you a single catheter for combined IVUS and OCT, so you can size vessels and assess plaque without swapping devices during PCI.

Cardiology · FDA — AI/ML-Enabled Medical Devices · 17 Apr

EdgeFlow UW20 — Edgecare, Inc. (FDA K252237)

This FDA-cleared AI ultrasound device may improve image acquisition or interpretation in radiology, potentially reducing diagnostic errors in your practice.

Radiology · FDA — AI/ML-Enabled Medical Devices · 17 Apr

Critical Care Suite with Enteric Tube Positioning AI Algorithm — Ge Medical Systems, LLC (FDA K253502)

Automates confirmation of enteric tube placement on X-rays, potentially reducing repeat imaging and aspiration risk in ICU patients.

Radiology · FDA — AI/ML-Enabled Medical Devices · 14 Apr

syngo Dynamics (VA41F) — Siemens Healthcare GmbH (FDA K253689)

This FDA-cleared AI tool can streamline your radiology workflow, potentially reducing reading time and improving diagnostic consistency in daily practice.

Radiology · FDA — AI/ML-Enabled Medical Devices · 10 Apr

TRIOS Dx (R1) — 3Shape TRIOS A/S (FDA K260082)

If you use intraoral scanners, this clearance signals AI diagnostics are entering routine dental workflows—expect caries or pathology flags on scans you already take.

Medicine · FDA — AI/ML-Enabled Medical Devices · 10 Apr

Relu Cloud — Relu BV (FDA K252708)

FDA-cleared AI cloud tool for radiology; check if it fits your workflow for faster, consistent reads.

Radiology · FDA — AI/ML-Enabled Medical Devices · 10 Apr

AI-Rad Companion Organs RT — Siemens Healthcare GmbH (FDA K252548)

This FDA-cleared AI tool automates organ segmentation for radiotherapy planning, potentially reducing contouring time and variability in your workflow.

Radiology · FDA — AI/ML-Enabled Medical Devices · 10 Apr

DeepBT Detector-Plus — Aitewan Biomedical Technology, Inc. (FDA K252190)

This AI tool may help you detect breast tumors more accurately on imaging, potentially reducing missed lesions in your daily reads.

Radiology · FDA — AI/ML-Enabled Medical Devices · 10 Apr

Seaman Pro/Seaman — Checkcells, Inc. (FDA K252228)

This FDA clearance signals a new AI hematology device entering the market; assess its validation before adopting in your lab.

Medicine · FDA — AI/ML-Enabled Medical Devices · 9 Apr

ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) — Anumana, Inc. (FDA K253801)

This AI ECG algorithm flags cardiac amyloidosis earlier from a routine 12-lead, enabling timely diagnosis and treatment in a condition often missed.

Cardiology · FDA — AI/ML-Enabled Medical Devices · 7 Apr

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) — Esaote, S.p.A. (FDA K253288)

New Esaote ultrasound systems cleared for radiology use; consider if upgrading your department's imaging capabilities for better diagnostic confidence.

Radiology · FDA — AI/ML-Enabled Medical Devices · 6 Apr

uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) — Shanghai United Imaging Healthcare Co., Ltd. (FDA K260524)

New PET/CT scanner family cleared for US use; consider for high-throughput imaging with AI-assisted reconstruction, potentially improving throughput and image quality.

Radiology · FDA — AI/ML-Enabled Medical Devices · 3 Apr

MAGENTIQ-COLO (ME-APDS) — Magentiq Eye, Ltd. (FDA K260724)

An AI polyp-detection device cleared for colonoscopy could raise your adenoma detection rate and reduce missed lesions during routine screening.

Gastroenterology · FDA — AI/ML-Enabled Medical Devices · 3 Apr

CoLumbo C-Spine — Smart Soft Healthcare AD (FDA K254015)

AI tool cleared for C-spine imaging may speed fracture detection and reduce missed injuries in emergency radiology.

Radiology · FDA — AI/ML-Enabled Medical Devices · 1 Apr

AiORTA - Plan v2.0 — ViTAA Medical Solutions, Inc. (FDA K254207)

Automates aortic measurements for endovascular planning, potentially reducing manual error and turnaround time in CT angiography cases.

Radiology · FDA — AI/ML-Enabled Medical Devices · 30 Mar

ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) — Anumana, Inc. (FDA K252360)

This AI ECG algorithm may help screen for pulmonary hypertension from a routine 12-lead, enabling earlier referral and diagnosis in primary care.

Cardiology · FDA — AI/ML-Enabled Medical Devices · 28 Mar

Spectral CT Verida Family — Philips Medical Systems Technologies , Ltd. (FDA K253649)

Spectral CT gives you material decomposition on routine scans, improving tissue characterisation and reducing need for follow-up imaging in complex cases.

Radiology · FDA — AI/ML-Enabled Medical Devices · 27 Mar

EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System — Philips Ultrasound, LLC (FDA K253595)

Philips ultrasound systems now cleared with AI features; if you use EPIQ or Affiniti, check which AI tools are enabled for your workflow.

Radiology · FDA — AI/ML-Enabled Medical Devices · 27 Mar

S-scan Open (100001800) — Esaote, S.p.A. (FDA K260746)

A new imaging device cleared for radiology use; check if it fits your workflow for better diagnostic access.

Radiology · FDA — AI/ML-Enabled Medical Devices · 27 Mar

Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR — Canon Medical Systems Corporation (FDA K253625)

AiCE deep-learning reconstruction on 1.5T MR can shorten scan times or boost resolution; consider for faster throughput and clearer images in routine neuro/musculoskeletal work.

Radiology · FDA — AI/ML-Enabled Medical Devices · 27 Mar

Butterfly Gestational Age Tool — Butterfly Network, Inc. (FDA K252148)

Enables point-of-care gestational age estimation on Butterfly ultrasound, potentially improving early pregnancy dating in low-resource settings.

Obstetrics & Gynaecology · FDA — AI/ML-Enabled Medical Devices · 27 Mar

Contour ProtégéAI+ — Mim Software, Inc. (FDA K253270)

AI auto-contouring can speed up radiotherapy planning, reducing manual delineation time and variability for your patients.

Radiology · FDA — AI/ML-Enabled Medical Devices · 27 Mar

Automated Aortic Stenosis Software (AutoAS) — GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (FDA K254161)

AutoAS automates aortic stenosis grading on ultrasound, potentially reducing measurement variability and helping you triage valve disease faster in clinic.

Cardiology · FDA — AI/ML-Enabled Medical Devices · 27 Mar