What You Should Know:
- TytoCare, a pioneering virtual care company dedicated to delivering accessible, high-quality primary care from the comfort of home announced the company has become the first in the world to receive FDA clearance for its AI-based detection of all three major abnormal lung sounds.
- The milestone was reached with the FDA clearance of Tyto Insights™ for Rhonchi Detection, completing TytoCare’s comprehensive AI-powered lung sound suite. With this latest
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FDA Clearance
Click Therapeutics Obtains FDA Authorization for First Prescription Digital Therapeutic for Migraine Prevention
What You Should Know:
- Click Therapeutics, Inc. (“Click”), a leader in the rapidly evolving field of prescription medical treatments, encompassing both prescription digital therapeutics (PDTs) and software-enhanced drug™ therapies has received FDA marketing authorization for CT-132, the first prescription digital therapeutic specifically indicated for the preventive treatment of episodic migraine in adults aged 18 and older.
- The FDA granted a De Novo Classification Request for
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Tandem Diabetes Care Receives FDA Clearance for Control-IQ+ Technology for Type 2 Diabetes
What You Should Know:
- Tandem Diabetes Care, a insulin delivery and diabetes technology company, announced that its Control-IQ+ technology has received clearance from the U.S. Food and Drug Administration (FDA) for use by adults with type 2 diabetes.
- The expanded indication builds on the success of Control-IQ+ in type 1 diabetes and offers a new automated insulin delivery (AID) option for individuals with type 2 diabetes.
Improve Glycemic Control for Adults with Type 2
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Ezra Receives FDA Clearance for Enhanced AI-Powered MRI Technology
What You Should Know:
- Ezra, a innovator in AI-driven cancer screening, today announced that its advanced Ezra Flash AI model has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
- The FDA clearance expands the capabilities of its AI-powered platform to provide faster, more affordable, and higher-quality full-body MRI scans.
Ezra Flash AI for MRI Image Quality
Ezra Flash, a Class II medical device, now enhances image quality for neuro, abdomen,
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Movano Health Receives FDA Clearance for Evie Ring Pulse Oximeter
What You Should Know:
- Movano Health, a health technology innovator, has achieved a significant milestone with the FDA 510(k) clearance of the pulse oximeter integrated into its Evie Ring.
- The FDA clearance paves the way for Movano to pursue new opportunities in health monitoring solutions, including clinical trials, post-clinical management, and remote patient monitoring.
Addressing the Limitations of Traditional Pulse Oximeters
Traditional pulse oximeters can be
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RSNA: Nonin Medical Launches First FDA-Cleared OTC Fingertip Pulse Oximeter for Accurate Readings Across Skin Tones
What You Should Know:
- Nonin Medical, a global leader in noninvasive medical monitoring lauches TruO2 OTC, the first over-the-counter (OTC) fingertip pulse oximeter to receive FDA clearance. This innovative device is designed to provide accurate blood oxygen saturation readings for adults across all skin tones, empowering individuals to make informed healthcare decisions.
- Nonin Medical's founder, Phil Isaacson, was the original inventor of the fingertip pulse oximeter. The
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GE HealthCare Receives FDA Clearance for SIGNA™ MAGNUS Head-Only MRI Scanner
What You Should Know:
- GE HealthCare (Nasdaq: GEHC) has received FDA 510(k) clearance for its innovative SIGNA™ MAGNUS, a 3.0T high-performance, head-only magnetic resonance imaging (MRI) scanner.
- This system offers new capabilities for both clinical imaging and neuroscience with the potential to aid in the detection of neurological, oncological, and psychiatric conditions.
SIGNA MAGNUS: Advancing Neuroimaging with Cutting-Edge MRI Technology
The FDA clearance of the SIGNA MAGNUS
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AccurKardia’s AI-Powered ECG Software Earns FDA Breakthrough Device Designation for Aortic Stenosis Detection
What You Should Know:
- AccurKardia, an innovator in ECG-based diagnostics technology, has announced that its Aortic Valve Stenosis (AVS) ECG-based AI screening software has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).
- The company’s AVS screening software aims to leverage the ubiquity of the electrocardiogram (ECG) to identify potential cases of AVS within millions of ECGs already present in healthcare system electronic health records in
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BioIntelliSense Optimizes Hospital Virtual Care with FDA-Cleared Rechargeable BioButton
What You Should Know:
- BioIntelliSense, a leader in continuous health monitoring, has received FDA clearance for its rechargeable BioButton Multi-Patient wearable and BioDashboard system.
- The BioButton is poised to transform hospital virtual care programs by providing a cost-effective and scalable solution for continuous patient monitoring.
Rechargeable and Reusable Wearable
The BioButton Multi-Patient wearable is a game-changer for inpatient settings. This
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GE HealthCare Receives FDA Clearance for Innovative Alzheimer’s Imaging Tool
What You Should Know:
- GE HealthCare announced today that its MIM Software has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a groundbreaking tool in the fight against Alzheimer's disease.
- The advancement allows MIMneuro, a vendor-neutral software solution, to perform "Centiloid scaling" for analyzing and quantifying amyloid plaque density in the brain using positron emission tomography (PET) imaging.
Impact of Alzheimer's
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