Archive

EchoNext — Pathwai, Inc. (FDA K260332)

AI-assisted echo analysis may speed up your workflow and flag subtle findings, but clinical validation is limited—use as an adjunct, not a replacement.

Cardiology · FDA — AI/ML-Enabled Medical Devices · 8 Jun

Instrument Exit Point on Touch Surgery™ Aide — Covidien, LLC (FDA K253984)

This AI tool flags instrument exit points during laparoscopic surgery, potentially reducing missed port-site injuries and improving intraoperative awareness.

General Surgery · FDA — AI/ML-Enabled Medical Devices · 4 Jun

DEEPVESSEL Plaque — Keya Medical Technology Co., Ltd. (FDA K260497)

AI tool cleared for plaque assessment—consider its use to standardize vascular risk reporting in your radiology practice.

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

Sonio Suspect — Sonio (FDA K261519)

This AI tool flags suspicious findings on ultrasound, potentially aiding early detection in your radiology workflow.

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

MeRT System — Wave Neuroscience (FDA K260402)

This clearance may expand access to MeRT for neurologists treating brain disorders, but clinical impact depends on evidence—check if it changes your protocol.

Neurology · FDA — AI/ML-Enabled Medical Devices · 3 Jun

HeartFocus — Deski (FDA K260780)

FDA-cleared AI for radiology; check if it improves your cardiac image interpretation workflow and diagnostic confidence.

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

Tyto Insights for Wheeze Detection (with PCCP) — Tyto Care , Ltd. (FDA K252844)

Adds automated wheeze detection to remote exams, aiding anaesthesiologists in pre-op screening and tele-consultations.

Anaesthesiology · FDA — AI/ML-Enabled Medical Devices · 2 Jun

GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) — Cosmo Artificial Intelligence - Ai, Ltd. (FDA K261369)

Adds an FDA-cleared AI polyp-detection option for colonoscopy; consider if your endoscopy suite upgrades to this module for real-time lesion spotting.

Gastroenterology · FDA — AI/ML-Enabled Medical Devices · 29 May

OrthoGrid Hip AI® 4.0 — OrthoGrid Systems, Inc. (FDA K260077)

AI guidance for hip implant placement may improve alignment accuracy and reduce revision risk in your arthroplasty cases.

Orthopaedics · FDA — AI/ML-Enabled Medical Devices · 29 May

HistoSonics® Planning Tool — HistoSonics, Inc. (FDA K252947)

This planning tool helps you target histotripsy more precisely, potentially improving outcomes in non-invasive tumour ablation.

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

ZEUS Platform (FG0501US) — iRhythm Technologies, Inc. (FDA K252859)

FDA-cleared AI platform for ECG analysis may streamline arrhythmia detection in your practice, potentially reducing manual review time.

Cardiology · FDA — AI/ML-Enabled Medical Devices · 29 May

ANDI 2.2 — Imeka Solutions, Inc. (FDA K261405)

This FDA clearance adds an AI tool for brain imaging analysis, potentially aiding radiologists in detecting abnormalities more efficiently.

Radiology · FDA — AI/ML-Enabled Medical Devices · 28 May

EPIQ Series Diagnostic Ultrasound System — Philips Ultrasound, LLC (FDA K260123)

New Philips ultrasound platform cleared for radiology use; check if your department's upgrade path improves image quality or workflow.

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

EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems — Philips Ultrasound, LLC (FDA K260680)

FDA clearance means Philips' EPIQ and Affiniti systems meet US regulatory standards, potentially expanding access to these diagnostic tools in India.

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

Synapse Lung Nodule AI — Fujifilm Corporation (FDA K254075)

Adds an FDA-cleared AI reader for lung nodules on CT; helps flag suspicious lesions earlier in your reporting workflow.

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

PCWP Analysis Software — Cardiosense, Inc. (FDA DEN250057)

This AI software estimates pulmonary capillary wedge pressure non-invasively, potentially reducing need for invasive catheterization in heart failure patients.

Cardiology · FDA — AI/ML-Enabled Medical Devices · 22 May

Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning — Canon Medical Informatics, Inc. (FDA K260324)

Automates CT measurements for TAVR sizing, potentially reducing planning time and inter-operator variability before valve deployment.

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

DeepView AI® System — spectralmd, inc. (FDA DEN250028)

FDA-cleared AI for skin lesion assessment may aid biopsy decisions in general surgery practice.

General Surgery · FDA — AI/ML-Enabled Medical Devices · 21 May

BAC — DeepHealth, Inc. (FDA K254131)

This AI tool may assist you in detecting breast cancer on mammograms, potentially improving accuracy and workflow in your radiology practice.

Radiology · FDA — AI/ML-Enabled Medical Devices · 21 May

MSK Go — Smart Alfa Teknoloji San. Ve Tic. A.S. (FDA K260234)

An AI radiology tool cleared by FDA; check if it fits your musculoskeletal imaging workflow for faster reads.

Radiology · FDA — AI/ML-Enabled Medical Devices · 21 May

uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite — Wuhan United Imaging Healthcare Co.,Ltd (FDA K253720)

New ultrasound systems cleared for radiology use; check if your department adopts them for improved imaging workflow.

Radiology · FDA — AI/ML-Enabled Medical Devices · 21 May

Aquilion ONE (TSX-308A/TSX-306A) V2.0 — Canon Medical Systems Corporation (FDA K253596)

If you report CTs, this cleared software update may change workflow or image quality—check your scanner's version before adopting.

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

uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super — Wuhan United Imaging Healthcare Co.,Ltd (FDA K253716)

New ultrasound systems cleared for US use; if you adopt them, verify image quality and workflow fit before replacing existing machines.

Radiology · FDA — AI/ML-Enabled Medical Devices · 15 May

Neurophet AQUA — Neurophet., Inc. (FDA K261273)

Adds an AI tool for brain MRI analysis to your radiology workflow; check if it fits your reporting needs for atrophy or lesion quantification.

Radiology · FDA — AI/ML-Enabled Medical Devices · 15 May

UNiD™ Spine Analyzer (SW3002) — Medicrea International S.A.S. (Medtronic) (FDA K261289)

AI-driven spine analyzer now FDA-cleared; may streamline surgical planning and improve accuracy for spinal procedures.

Radiology · FDA — AI/ML-Enabled Medical Devices · 15 May

SubtleHD-CT (1.x) — Subtle Medical, Inc. (FDA K254120)

Lets you lower CT dose or improve image quality via AI denoising, potentially reducing patient radiation exposure in routine scans.

Radiology · FDA — AI/ML-Enabled Medical Devices · 15 May

Neurophet SCALE PET — Neurophet., Inc. (FDA K252563)

Automates PET quantification for neurodegenerative assessment, potentially reducing manual measurement time and variability in your radiology workflow.

Radiology · FDA — AI/ML-Enabled Medical Devices · 15 May

Embryo Predict — Alife Health (FDA K250781)

This FDA-cleared AI tool may help you select embryos with higher implantation potential, potentially improving IVF success rates.

Obstetrics & Gynaecology · FDA — AI/ML-Enabled Medical Devices · 15 May

BriefCase-Triage — Aidoc Medical , Ltd. (FDA K261317)

This AI triage tool flags urgent findings on scans, helping you prioritize critical cases and reduce turnaround time.

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

SubtleHD-PET (1.x) — Subtle Medical, Inc. (FDA K254013)

This AI tool enhances PET image quality, potentially reducing scan time or dose while maintaining diagnostic clarity—relevant for radiology workflow efficiency.

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

Morph — BeauBrain Healthcare, Inc. (FDA K260032)

An AI radiology tool cleared by FDA; if adopted in India, it could streamline reporting workflows, but clinical impact depends on local validation.

Radiology · FDA — AI/ML-Enabled Medical Devices · 13 May

Rayvolve — AZmed (FDA K260378)

This FDA clearance adds another AI tool for radiology; check if it fits your workflow to reduce reading time.

Radiology · FDA — AI/ML-Enabled Medical Devices · 12 May

Velmeni for Dentists (V4D) Endo-Perio — Velmeni, Inc. (FDA K252953)

This AI tool flags endo-perio findings on dental X-rays, potentially reducing missed lesions in your practice.

Radiology · FDA — AI/ML-Enabled Medical Devices · 11 May

Veritas Reverse Total Shoulder System — Restor3D (FDA K253992)

Gives Indian orthopaedic surgeons a new reverse shoulder option for complex cases, though no India-specific data or availability is noted.

Orthopaedics · FDA — AI/ML-Enabled Medical Devices · 7 May

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