What You Should Know
- AccurKardia has announced its second FDA 510(k) clearance for the AccurECG™ Analysis System (v2.0). This enterprise-grade, cloud-based platform is designed to ingest data from any ECG hardware—including patches and Holters—and deliver fully automated, near real-time interpretation for 13 rhythm classifications with 99% accuracy.
- As cardiac data volumes surge due to the proliferation of wearables, AccurECG 2.0 allows hospitals and independent diagnostic testing
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FDA Clearance
RapidAI Secures FDA Clearance for Five New Deep Clinical AI Modules, Expanding Enterprise Imaging Platform
What You Should Know:
- RapidAI, a pioneer in deep clinical AI, announced U.S. FDA clearance for five new imaging modules—Rapid DeltaFuse™, Rapid LMVO, Rapid MLS, Rapid OH, and Rapid Aortic for measurement.
- The expansion reinforces the Rapid Enterprise™ Platform’s focus on bringing deep clinical intelligence and seamless workflow integration across the entire patient journey.
Deep Clinical AI: Shifting Beyond Triage to Full Patient Management
RapidAI’s latest FDA clearances
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Ceribell Receives FDA Clearance for Clarity® AI, Becoming First Point-of-Care EEG for All Ages
What You Should Know:
- Ceribell, Inc. today announced that the U.S. FDA has granted 510(k) clearance for its next-generation Clarity® algorithm.
- The FDA clearance makes the Ceribell System the first and only AI-powered point-of-care electroencephalography (EEG) technology available to detect electrographic seizures in all patients, from pre-term neonates through adults.
Closing a Critical Unmet Need in Neonatal Care
The FDA clearance for the Clarity® algorithm to
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GE HealthCare Submits Photonova™ Spectra for FDA Clearance: Deep Silicon Detectors Power New PCCT System
What You Should Know:
- GE HealthCare has announced the submission of a 510(k) to the U.S. FDA for Photonova™ Spectra, its new photon-counting computed tomography (PCCT) system with advanced AI algorithms.
- Built on proprietary Deep Silicon detector technology, the system aims to redefine diagnostic confidence by delivering ultra-high-definition (UHD) imaging, enhanced material separation, and rapid acquisition speeds.
Photon Counting CT with Deep Silicon
GE HealthCare's
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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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DeepHealth Receives FDA Clearance for Remote Scanning Solution, TechLive™
What You Should Know:
- DeepHealth, a subsidiary of RadNet, has received FDA 510(k) clearance for its new remote scanning solution, TechLive™. The vendor-agnostic platform is designed to address the growing radiology technologist shortage by allowing experts to remotely operate and supervise MR, CT, PET/CT, and Ultrasound procedures from a centralized command center.
- The move comes at a critical time for the healthcare industry, which has seen radiology workloads steadily increase
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Build Smart, Not Fast: What the FDA Really Cares About in Digital Therapeutics
Digital therapeutics (DTx) are revolutionizing healthcare — from smart inhalers to virtual therapy avatars. As more patients turn to DTx apps, companies rush to deliver innovative features. But in the race to innovate, many developers neglect vital elements of success, leading to major setbacks, especially when seeking FDA approval. It’s time to find a practical path forward to mitigate risk and scale smarter.
The Digital Therapeutics Trifecta:
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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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FDA Approves Drug-Free AI-Powered Wearable for Nasal Congestion for Kids
What You Should Know:
- SoundHealth, a medical technology company leveraging artificial intelligence and medical science, recently announced it has received U.S. Food and Drug Administration (FDA) approval for pediatric use of its SONU Band.
- The AI-enabled wearable device is now cleared as the first FDA-approved, drug-free solution for treating moderate to severe nasal congestion due to allergic and non-allergic rhinitis in children aged 12 and up, offering a safe alternative
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