What You Should Know
DeepHealth, Inc. (a wholly owned subsidiary of RadNet, Inc.) received FDA 510(k) clearance for DeepHealth Breast Ultrasound, an AI platform automating lesion detection, ACR BI-RADS characterization, and reporting.The commercial software allows U.S. healthcare providers to pursue reimbursement under an existing Category III CPT code for quantitative ultrasound tissue characterization.RadNet plans to deploy the platform across its national outpatient network by the end of
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FDA clearance 510k
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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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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11 Recent Digital Health FDA Clearances You Need to Know: AI, Wearables, and Robotics Drive Precision Medicine Forward
What You Should Know:
- The U.S. Food and Drug Administration (FDA) has recently issued several key clearances, marking significant advancements across diagnostics, surgery, and remote patient monitoring.
- These FDA clearances reflect a deepening integration of Artificial Intelligence (AI) and advanced technology into clinical workflows, promising greater precision, reduced invasiveness, and expanded access to care.
Diagnostics and Remote Monitoring: AI and Wearables at Scale
A
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Heartflow Receives FDA Clearance for Next-Gen AI Plaque Analysis, Expands Cigna Coverage
What You Should Know:
- Heartflow, a leader in AI technology for coronary artery disease (CAD), has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Next Gen Heartflow Plaque Analysis algorithm and platform.
- The technology features an updated algorithm, an expanded nomogram, and advanced 3D color-coded visualization of plaque, empowering clinicians with crucial insights for confident care decisions. In addition, Heartflow announced that Cigna will
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PathAI Granted FDA Clearance for AISight Dx for Primary Diagnosis in Clinical Settings
What You Should Know:
- PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its digital pathology image management system, AISight® Dx, for use in primary diagnosis in clinical settings.
- The FDA clearance builds upon the platform's initial 510(k) clearance for AISight Dx(Novo) in 2022, demonstrating PathAI’s ongoing commitment to innovation and
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Withings Sleep Rx Receives FDA Clearance for Home Sleep Apnea Testing
What You Should Know:
- Withings, a global leader in connected health, has announced that its Sleep Rx sleep apnea device has received clearance from the U.S. Food and Drug Administration (FDA).
- Sleep Rx represents a significant advancement in the diagnosis of sleep apnea, offering a more convenient and accurate alternative to traditional in-lab testing.
Addressing the Underdiagnosis of Sleep Apnea
Sleep apnea is a serious condition that affects millions of people
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Philips IntelliSite Pathology Solution Receives 510(k) Clearance
What You Should Know:
- Philips IntelliSite Pathology 5.1 has received 510(k) clearance from the FDA, solidifying its position as the most widely deployed digital pathology solution for primary diagnosis globally.
- With over 300 pathology labs already implementing Philips' solution, and over 20 labs achieving complete digital workflows, the success of this technology is evident.
Investing in the Future of Cancer Care
By empowering collaboration, boosting efficiency, and
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