Archive

Stealth AXiS Cranial clinical application — Medtronic Navigation, Inc. (FDA K253379)

New FDA-cleared navigation software for cranial procedures—check if your centre adopts it to improve intraoperative accuracy and workflow.

Neurology · FDA — AI/ML-Enabled Medical Devices · 26 Mar

Lunit INSIGHT DBT (V1.2) — Lunit, Inc. (FDA K253796)

AI tool for digital breast tomosynthesis may help you detect cancers earlier and reduce recalls in screening.

Radiology · FDA — AI/ML-Enabled Medical Devices · 26 Mar

SwiftMR — Airs Medical, Inc. (FDA K253775)

This AI speeds up MRI scans, cutting patient time and improving throughput—useful for busy Indian radiology practices.

Radiology · FDA — AI/ML-Enabled Medical Devices · 26 Mar

Trinias — Shimadzu Corporation (FDA K252099)

This FDA clearance adds an AI-enabled imaging device option for radiology practices, potentially improving workflow or diagnostic accuracy in your department.

Medicine · FDA — AI/ML-Enabled Medical Devices · 24 Mar

JLK-NCCT — JLK, Inc. (FDA K252421)

This FDA-cleared AI tool may help you interpret non-contrast CTs faster, potentially reducing missed findings in urgent scans.

Radiology · FDA — AI/ML-Enabled Medical Devices · 24 Mar

LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power — GE Medical Systems Ultrasound and Primary Care Diagnostics (FDA K260673)

Expands GE's AI-enabled ultrasound portfolio in India, offering clinicians validated imaging tools for faster, more consistent point-of-care diagnosis.

Radiology · FDA — AI/ML-Enabled Medical Devices · 24 Mar

True Definition DL — Ge Healthcare Japan Corporation (FDA K253686)

This FDA clearance signals another AI imaging tool entering practice; check if it fits your workflow before adopting.

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

CT Rembra RT; CT Areta RT; CT Rembra — Philips Healthcare (Suzhou) Co., Ltd. (FDA K252992)

Philips' AI-based CT reconstruction may reduce radiation dose or improve image quality, affecting your scan protocols and patient safety.

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

Photonova Spectra, Photonova Spectra Select — Ge Medical Systems, LLC (FDA K253520)

New GE imaging devices cleared for radiology—check if they improve workflow or image quality in your setting.

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

SOMATOM X.cite; SOMATOM X.ceed — Siemens Medical Solutions USA, Inc. (FDA K253574)

New Siemens CT systems cleared for use; if you're in radiology, check if your facility's upgrade path includes these models for improved imaging.

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

AutoContour (RADAC V5) — Radformation, Inc. (FDA K260509)

Auto-segmentation speeds contouring in radiotherapy planning, cutting manual work and variability—relevant if you plan or review radiation cases.

Radiology · FDA — AI/ML-Enabled Medical Devices · 19 Mar

syngo.via RT Image Suite VC10 — Varian Medical Systems, Inc. (FDA K252304)

This FDA clearance means you can now use this AI-enabled imaging suite for radiotherapy planning, potentially improving contouring accuracy and workflow efficiency in your department.

Radiology · FDA — AI/ML-Enabled Medical Devices · 18 Mar

Tyto Insights for Eardrum Bulging Detection — Tyto Care , Ltd. (FDA DEN250014)

This AI tool flags eardrum bulging from otoscopy images, aiding remote diagnosis of otitis media in primary care.

Medicine · FDA — AI/ML-Enabled Medical Devices · 17 Mar

EchoNavigator R5.0 — Philips Medical Systems Nederland B.V. (FDA K253614)

Philips' EchoNavigator R5.0 gains FDA clearance, aiding real-time fusion imaging during structural heart procedures—relevant for interventional radiologists and cardiologists in India.

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

SurgiCount+ System — Stryker Instruments (FDA K252282)

Helps prevent retained surgical sponges with automated counting—reduces OR errors and patient harm.

General Surgery · FDA — AI/ML-Enabled Medical Devices · 16 Mar

Sonio Detect (v3) — Sonio (FDA K252433)

FDA-cleared AI for fetal ultrasound may streamline your scan workflow and flag anomalies earlier, but validate on your population.

Radiology · FDA — AI/ML-Enabled Medical Devices · 16 Mar

Data Analysis Facilitation Suite (DAFS) — Voronoi Health Analytics Incorporated (FDA K253944)

This FDA-cleared AI suite may streamline radiology data analysis, potentially reducing reporting time and aiding diagnostic workflows in your practice.

Radiology · FDA — AI/ML-Enabled Medical Devices · 16 Mar

InferCare RECIST — Beijing Infervision Healthcare Medical Technology Co., Ltd. (FDA K252261)

Automates RECIST tumor measurements on CT, saving radiologist time and improving consistency in oncology response assessment.

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

Deep Capsule® (Deep Capsule US) — Digestaid - Artificial Intelligence Development SA (FDA K250655)

AI-assisted capsule endoscopy reading may reduce your review time and improve lesion detection in obscure GI bleeding.

Gastroenterology · FDA — AI/ML-Enabled Medical Devices · 12 Mar

Tyto Stethoscope (G3) — Tyto Care , Ltd. (FDA K252089)

Lets you capture and share heart sounds remotely, supporting tele-consultations and follow-ups without an in-person visit.

Cardiology · FDA — AI/ML-Enabled Medical Devices · 12 Mar

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) — Canon Medical Systems Corporation (FDA K253584)

Expanded field-of-view on Canon fluoroscopy reduces need for manual repositioning during long interventions, saving time and radiation exposure.

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

LiverMultiScan (v6.0) — Perspectum, Ltd. (FDA K253413)

Adds an FDA-cleared MRI tool to quantify liver fat and fibrosis non-invasively, potentially reducing biopsy need in NAFLD patients.

Radiology · FDA — AI/ML-Enabled Medical Devices · 9 Mar

Onera SleepMap (SLEEPMAP) — Onera B.V. (FDA K253668)

FDA-cleared AI sleep monitor may offer home-based assessment, potentially reducing need for in-lab polysomnography in select patients.

Neurology · FDA — AI/ML-Enabled Medical Devices · 8 Mar

Mazor X System / Mazor X Stealth Edition — Mazor Robotics Ltd. (FDA K251316)

Spine surgeons can now use this cleared navigation platform to improve screw placement accuracy and reduce revision rates in complex procedures.

Neurology · FDA — AI/ML-Enabled Medical Devices · 11 Sept

Proton’s device aims to help those with kidney disease and cut heart-failure risks

A wearable potassium monitor could let you catch life-threatening imbalances early in CKD or heart-failure patients, shifting care from crisis to prevention.

Medicine · TechCrunch — Health · 24 Dec

YouTube is making it easier to find accurate information about first aid and emergency care

When patients search for emergency steps, they'll now see vetted videos from credible sources, reducing reliance on unverified clips that could mislead care.

General Medicine · TechCrunch — Health · 10 Jan

Withings’ new multiscope device checks vitals for telehealth visits

Enables patients to capture ECG, heart sounds, and more at home, making telehealth assessments more reliable for remote consultations.

General Medicine · TechCrunch — Health · 8 Jan

Google unveils MedLM, a family of healthcare-focused generative AI models

MedLM may soon assist you with clinical documentation and decision support, but evidence of real-world benefit is still pending.

Medicine · TechCrunch — Health · 13 Dec