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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
Coming back from a complete response letter (CRL) for its Udenyca Onbody drug device combo, Coherus BioSciences has received FDA approval of the product to decrease the incidence of febrile neutropenia after chemotherapy. Read More
In this edition of Quick Notes, we look at FDA breakthrough designation for a pulsed ablation system for treatment of atrial fibrillation, an implant to treat glaucoma and ocular hypertension, a label expansion for a game-based digital therapeutic device for adolescents with ADHD, and an antigen test to detect the presence of a cancer-causing bacteria. Read More
In this edition of Quick Notes, we look at 510(k) clearances for an at-home intravaginal insemination kit, a fingertip blood collection device, first surgical navigation system for total ankle arthroplasty, a rapid anthrax toxin test, an AI-based chest x-ray triage solution, and an acute kidney injury biomarker test for pediatric use. Read More
The FDA has updated its eSTAR online medical device 510(k) application submission process — which became mandatory as of Oct. 1 — to include additional submission types. Read More
In this edition of Quick Notes, we look at expanded clearance for a smart watch, a retinal camera with designs on uncovering health problems, new software to better track neurological disease and a way to increase radiologists’ efficiency by enabling remote review of MRI scans. Read More