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 Clearance
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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Arineta’s SpotLight Duo CT Scanner Receives FDA Clearance for Low-Dose Lung Cancer Screening
What You Should Know:
- Arineta, a leader in advancing cardiovascular imaging solutions, announced that its SpotLight™ Duo cardiac CT scanner has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for low-dose lung cancer screening (LDCT).
- The regulatory milestone allows healthcare providers to utilize a single, ultra-fast CT platform for both comprehensive cardiac imaging and vital lung cancer screening, offering more complete and efficient care for
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Osteoboost Launches First FDA-Cleared Prescription Wearable Nationwide to Combat Low Bone Density
What You Should Know:
- Osteoboost Health announced the nationwide availability of Osteoboost, a groundbreaking prescription medical device. Osteoboost aims to provide hope for millions diagnosed with low bone density, helping to reduce the risk of fractures that can severely impact mobility and independence.
- As the first and only FDA-cleared device of its kind for low bone density, Osteoboost introduces a novel, protective, and preventative approach to bone health, offering a new
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World’s First AI Lung Sound Suite: TytoCare Gets FDA Clearance for Rhonchi
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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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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