This week, a device center stalwart prepared to say goodbye; the FDA cleared Fresenius's 5008X Hemodialysis System; and class I recalls for Smiths Medical and Philips Imaging were announced.
Device official William Maisel has announced plans to retire from the US Food and Drug Administration this spring.
Maisel has been director of the Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health since 2019
This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.
This week, the FDA announced a new head of its device evaluation office; synthetic genomics firm Constructive Bio landed $58m in funding; and Natera got a permanent injuction against NeoGenomics Labs' RaDaR assay.
This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.
