FDA– tag –
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Median Technologies’ AI-Powered Lung Cancer Screening Software ‘eyonis® LCS’ Secures Dual FDA 510(k) Clearance and CE Mark
Business Wire France Overview Median Technologies, a French company, announced that its AI-driven medical device software (SaMD), eyonis® LCS, a lung cancer screening and early diagnosis support tool, received both FDA 510(k) clearance a... -
VELMENI Secures FDA 510(k) Clearance for AI-Powered 3D CBCT Dental Imaging Software ‘VELMENI for DENTISTS (V4D) 3D,’ Expanding Dental AI Portfolio
PR Newswire USA Overview VELMENI announced that its AI-powered 3D Cone Beam Computed Tomography (CBCT) dental imaging software, 'VELMENI for DENTISTS (V4D) 3D,' has received 510(k) clearance from the U.S. Food and Drug Administration (FD... -
HoneyNaps Receives FDA 510(k) Clearance for AI Software SOMNUM V3.0 for Subtype-Specific Sleep Apnea Classification
Sleep Review USA Overview HoneyNaps, a South Korean company, announced that its AI diagnostic software, SOMNUM V3.0, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The software automatically detects and c... -
AI Integration Transforms Clinical Trials: Boosting Efficiency, Accelerating Development, and Navigating Ethical Frontiers
Krishna School Of Pharmacy & Research (via IJPS Journal) India Overview A review highlights the escalating integration of AI, encompassing machine learning, deep learning, predictive analytics, and natural language processing, across all... -
Consumer Smartwatch Technology in Health and Performance Research: Validity, Limitations, and the Challenge of Non-Invasive Glucose Sensing Highlighted
MDPI Switzerland Overview This review examines the validity, limitations, and real-world applications of consumer smartwatch technology in health and performance research, emphasizing the need for stronger validation and standardized dat... -
Wizbiotech Boosts Pharmacy Revenue with In-Store Fingerstick POCT Testing via 3-in-1 Immunoassay Analyzer for HbA1c, Vitamin D, and Ferritin
Xiamen Wiz Biotech Co., Ltd. China Overview Wizbiotech is promoting its 3-in-1 POCT immunoassay analyzer for in-store fingerstick testing in pharmacies globally, offering accurate quantitative HbA1c, Vitamin D, and Ferritin testing. This... -
Medtronic Introduces Instinct Sensor, Expands MiniMed 780G System to Type 2 Diabetes with Dual FDA Clearances
Simply Wall St USA Overview Medtronic has expanded its diabetes sensor portfolio with the launch of the Instinct sensor, complementing its Simplera Sync™ and Guardian™ 4 sensors. The company also secured two key U.S. FDA regulatory miles... -
Wireless Wearable Biosensors Advance Real-Time Health Monitoring: Capabilities and Challenges Explored
AZoLifeSciences Unknown Overview This article discusses the rapid advancements in wireless, battery-free wearable biosensors for continuous health monitoring. These devices track physiological signals and biomarkers like glucose, lactate... -
Dexcom G7 15-Day Continuous Glucose Monitor Authorized by Health Canada, Stelo CGM Cleared for Pediatric OTC Use by U.S. FDA
Business Wire, MarketScreener, CureCapture, Oura Member Care USA, Canada Overview Dexcom's G7 15-day continuous glucose monitoring (CGM) system has received Health Canada authorization for adults aged 18 and older, extending wear time to... -
Lyora Launches with Seed Funding to Propel Ophthalmic Gene Therapy Assets, Targeting IND Submission Within 18 Months
Cellgenetherapyreview.com USA Overview Lyora announced on July 14, 2026, the successful completion of its seed funding round and the official launch of operations, aimed at advancing its ophthalmic gene therapy assets. The company plans ...
