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As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
In this edition of Quick Notes, the FDA clears an endoscopic camera capsule for home use, some of GE Healthcare’s ultrasound imaging software shows cyberattack vulnerability, and the FDA clears self-collection of vaginal swabs for HPV testing, and OKs a new cardiac cath guidewire. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
This edition of Quick Notes reviews the FDA’s 510(k) clearance of Outset Medical’s TabloCart as well as perfusion imaging analysis by RapidAI and an OTC version of the Masimo Stork baby monitor. FDA approval was granted to Genescopy’s ColoSense. Read More
This week, the FDA announced its final rule for laboratory developed tests. Draft guidances were published on enforcement policies for tests during a Section 564 declared emergency, IVD enforcement policy in the absence of a Section 564 emergency declaration and a REMS logic model. Advisory committee meetings were announced for Donanemab, Lilly’s Alzheimer’s drug and for Midomafetamine capsules. Read More
This edition of Quick Notes reviews the FDA’s 510(k) clearance of a ZygoFix spinal fusion device, GE Healthcare’s vital signs monitor, an EEG monitoring system and AI for event detection by Epitel, and BMF cosmetic dental veneers. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, thathas been acted on since Oct. 1, 2023 to keep you updated on laws andregulations that could impact your business. Read More
In this edition of Quick Notes are drug approvals to treat hemophilia B, rare genetic disorder WHIM, cervical cancer, cluster seizures in children with epilepsy and a new formulation of a drug for movement disorders. Read More
This week, the FDA announced a Metabolic Drugs Advisory Committee meeting and a listening session on advisory committees. Draft guidances were published on content and format of NDA and ANDA labeling statements, use of human- and animal-derived materials in the manufacture of CGT and TEMP products, safety testing of human allogeneic cells. Read More
This edition of Quick Notes reviews the FDA’s approval of Medtronic’s closed-loop rechargeable spinal cord stimulator, Abbott’s below the knee Everolimus Eluting Resorbable Scaffold System, an integrated continuous glucose monitor, and clearance of AEYE Health’s AI that diagnoses referable diabetic retinopathy. Read More
This edition of Quick Notes provides an overview of four recently released draft guidances on the manufacture of cell-based products and on the FDA’s enforcement policy regarding test manufacturers’ offering of certain unapproved tests during a future declared emergency or in the absence of such a declaration. Read More