The FDA offers new recommendations for testing and information to include in 510(k) submissions for dental resin devices and the ultraviolet curing lights used to set the resins, in two…
The FDA issued a complete response letter (CRL) to Novo Nordisk for insulin icodec — a once-weekly long-acting human insulin analogue — raising questions about the manufacturing process and the…
The FDA has finalized its guidance on crafting phase 3 clinical trials for devices designed to treat opioid use disorder (OUD), providing sponsors with direction on defining patient populations, recording…
Health care providers and facilities are being warned by the FDA to stop using Medtronic NIM (neural integrity monitor) Contact EMG (electromyogram) reinforced endotracheal tubes and NIM Standard EMG reinforced…
Lost in the politics-oriented follow up to the presidential debate between Joe Biden and Donald Trump was the substance of what they both said during the debate about the actual…
The FTC submitted a comment supporting a proposed US Patent and Trademark Office (USPTO) rule to address patent system abuse such as the creation of overlapping patent rights known as…
The nation’s largest pharmacy benefit managers (PBM) have drastically consolidated to a select and much-enriched few while wielding “enormous power and influence” over American consumers, the FTC illustrated in a…
To aid drug and device makers in battling misinformation about their products, the FDA has issued a 21-page question-and-answer draft guidance that provides firms with ways to address the issue.…
This edition of Quick Notes looks at FDA approvals and clearances for devices involving digital pathology images, implantable device protective pockets, and measurement/monitoring systems for obstetrical and cardiac care. Source:…
The potential for radiofrequency coils heating up during an MRI scan has led the FDA to deem Philips’ recall of its Sense XL Torso Coils as Class I, as overheating…