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This edition of interesting device approvals and clearances includes a pulsed field ablation system, a transesophageal echocardiography ultrasound transducer, a digital cytology system that combines deep-learning-based AI, and a deep brain stimulation system. Read More
This edition of Quick Notes looks at the FDA approving devices and systems that detect and/or offer treatment for potential skin cancer, Alzheimer’s, lung fibrosis and diabetic neuropathy. Read More
After an October 2022 advisory committee rejection of its initial genetic test for risk of opioid use disorder (OUD), SOLVD has won FDA approval for a revamped version of its DNA-based AvertD test. Read More
Familiarity with FDA regulations on the agency’s processes for approving drugs and devices is lacking among doctors, but differs by specialty, according to a national survey of physicians conducted by University of California San Francisco (UCSF) researchers. Read More
This edition of Quick Notes includes coverage of a cloth vest/halter that continuously monitors blood pressure, a Mayo Clinic deal on a newly cleared breast tumor 3D modeling device, and Medtronic clearances for a deep brain stimulation system for movement disorders and an insulin delivery system. Read More
This edition of Quick Notes looks at recent FDA medical device clearances and designations for EndoSound, EndoQuest Robotics, Perfuze, AnX Robotics, CGBio. Read More
Acclarent, a division of Johnson & Johnson, has received FDA clearance for use of its AERA eustachian tube balloon dilation system in the treatment of children age 8-17 with persistent obstructive eustachian tube dysfunction (OETD), the first such treatment available for children. Read More