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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
Lapses in digital security, missed report deadlines, and a complete lack of quality oversight earned manufacturers some notable 483s. And here’s a first: How about getting written up for being too clean? Read More
In this edition of Quick Notes, we hop across the pond to check out the EMA’s new regulatory fees structure, its updated submissions communication portal, and the sixth update of its guideline on the clinical evaluation of anticancer medicinal products. 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
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
This edition of Quick Notes highlights drug approvals from regulators in the U.S. and Europe, while confirming December so far has been a pretty good month for Astellas Pharma with several drug approvals in the U.S. and EU. 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
This edition of Quick Notes looks across the pond at Europe’s new critical medicines list, reference labs for high-risk IVDs, guidelines for adverse reaction follow-ups and a tweaked website. Read More