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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
Vivos Therapeutics achieved a first in obtaining FDA clearance of its removable oral appliance for severe obstructive sleep apnea — an alternative to continuous positive airway pressure (CPAP) or surgical implants — while Philips Respironics deals with potential overheating issues in its DreamStation 2 CPAP devices. Read More
This edition of Quick Notes highlights a major supplier’s data breach, good news for wearable defibrillator and renal denervation devices, and labeling to remind surgeons about nonapproved mesh products. Read More