The company is recalling all unused Lotus Edge inventory and will stop developing the Lotus platform while shifting resources to support its Acurate neo2 transcatheter aortic valve system. The decision will cost the company up to $300m.
Boston Scientific is recalling all unused Lotus Edge transcatheter aortic valve replacement (TAVR) systems and is immediately retiring the entire Lotus technology platform, including all commercial, clinical, research, development and manufacturing activities related to the Lotus TAVR technology.
The company initiated a global, voluntary recall of Lotus Edge on 17 November due to ongoing “complexities” with the valve’s...
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.
Spain has one of the highest incarceration rates in Europe, with 160 individuals imprisoned per 100,000 residents. In 2020, 43,494 people were incarcerated in facilities not managed by regional health authorities — essentially all regions except Catalonia, the Basque Country, and Navarra.
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.
The US FDA released six more device classifications in early September, including products from Edwards, Interscope, and Baxter Healthcare.
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.
