What You Should Know
Oxford spin-out Caristo Diagnostics has secured FDA De Novo authorization for CaRi-Heart®, making it the first and only technology authorized in the U.S. to quantify coronary inflammation from routine Coronary CT Angiography (CCTA).CaRi-Heart uses advanced AI to analyze inflammation-driven changes in the pericoronary adipose tissue, generating a Fat Attenuation Index Score (FAI-Score™) and a 10-year personalized cardiovascular mortality risk estimate.The FDA clearance
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FDA Clearance
Philips Earns FDA 510(k) Clearance for Next-Generation Reusable SpO₂ Clip Sensor
What You Should Know
Philips has officially secured U.S. FDA 510(k) clearance for its next-generation reusable SpO₂ clip sensor.In controlled desaturation studies, the enhanced sensor achieved an Accuracy Root Mean Square (ARMS) value of 1.6%—nearly twice as accurate as the 3% threshold recommended by ISO guidelines and recognized by the FDA.Addressing industry-wide pulse oximetry disparities, the sensor demonstrated consistent clinical performance across a broad spectrum of skin tones, with
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FDA Grants 510(k) Clearance for Glooko’s EndoTool IV Cloud Insulin Dosing Platform
What You Should Know
Glooko has received U.S. FDA 510(k) clearance for EndoTool IV Cloud, making it the first cloud-based, patient-specific insulin dosing platform cleared for hospital use.The system is the cloud-native evolution of EndoTool IV, a clinical decision support solution used to manage intravenous (IV) insulin therapy for hospitalized patients.The cloud architecture is designed to reduce on-premise infrastructure requirements, streamline maintenance, and support centralized updates
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TytoCare Receives FDA De Novo Classification for Tyto Insights ENT Suite AI Image Analysis
What You Should Know
TytoCare has received FDA De Novo classification for its Tyto Insights™ for ENT Suite, creating a first-of-its-kind regulatory category for "ear, nose, and throat image analyzers".The AI-powered tool automatically analyzes otoscopy video to detect eardrum bulging, a primary indicator of Acute Otitis Media and other common pediatric conditions.Designed for patients aged six months and older, the system uses a proprietary database of 1.6 million ear images to provide
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Butterfly Network Receives FDA Clearance for AI-Powered Gestational Age Ultrasound Tool
What You Should Know
The Milestone: Butterfly Network has received FDA clearance for a fully automated Gestational Age (GA) Tool integrated directly into its handheld, semiconductor-based ultrasound devices. It is the first FDA-cleared "blind-sweep" ultrasound AI tool for estimating gestational age.The Efficacy & Scale: The tool is proven to deliver results equivalent to a trained sonographer for patients between 16 and 37 weeks. Backed by the Gates Foundation, the tool is already
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GE HealthCare Secures FDA 510(k) Clearance for Photonova Spectra Photon-Counting CT
What You Should Know
The Milestone: GE HealthCare has officially received FDA 510(k) clearance for Photonova Spectra, its highly anticipated photon-counting computed tomography (PCCT) system.The Core Technology: Unlike traditional CT scanners that convert X-rays into visible light before measuring them, PCCT directly counts individual photons and measures their energy. GE is utilizing a proprietary Deep Silicon detector architecture that provides 8-bin energy resolution to virtually eliminate
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HIMSS26: GE HealthCare’s Genesis Radiology Workspace ‘View’ Receives FDA 510(k) Clearance
What You Should Know:
The Clearance: GE HealthCare has officially received FDA 510(k) clearance for View, a fast, zero-footprint diagnostic viewer. This viewer serves as the core anchor of the Genesis Radiology Workspace.The Clinical Bottleneck: Currently, radiologists spend up to 44% of their time on non-interpretive tasks. These tasks include navigating complex interfaces or waiting for images to load, which directly impacts productivity and turnaround times.The Solution: View is engineered
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GE HealthCare Receives FDA Clearance for Allia Moveo Interventional Imaging System
What You Should Know
The Launch: GE HealthCare has received FDA 510(k) clearance and CE Marking for Allia™ Moveo, a new mobile C-arm system designed for cardiovascular and interventional procedures.The Design: The system addresses the physical constraints of the operating room. It is compact and cable-free, featuring a "wide-bore" design that accommodates patients of any size while allowing effortless table panning.The AI: The platform integrates CleaRecon DL, an AI-driven tool that removes
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Proprio Secures 4th FDA Clearance for AI-Powered ‘Picasso’ Spine Guidance
What You Should Know:
- Proprio has secured FDA clearance for Picasso, its fourth cleared capability within the Paradigm AI surgical platform.
- The feature enables "trace-based" optical registration, allowing spine surgeons to perform real-time, radiation-free 3D measurements of spinal alignment during surgery—addressing a critical gap where surgeons previously relied on static 2D X-rays or postoperative confirmation.
Radiation-Free "Digital Twins"
Legacy navigation
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AliveCor Receives FDA Clearance for 39 Determinations on Kardia 12L AI
What You Should Know
- AliveCor, the global leader in AI-powered cardiology, has received U.S. FDA clearance for the next generation of its KAI 12L AI. This update expands the diagnostic breadth of the Kardia 12L ECG System to detect five additional cardiac determinations, bringing the platform’s total to 39 cleared determinations.
- The handheld, 0.3-pound device can now identify specific rhythm modifiers and axis-related morphologies, providing clinicians with unprecedented diagnostic
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