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.

Fresenius and Formycon have celebrated simultaneous US and EU approvals for the firms’ partnered Otulfi ustekinumab rival to Stelara. And with competing biosimilars already available on the European market, all eyes will soon be on US launches at the start of 2025, with Fresenius providing a significant update on launch timing.

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.

Fresenius Kabi has completed the divestment of its Chilean subsidiary Laboratorio Sanderson to Peru’s Medifarma, including the transfer of an IV drug facility in Santiago de Chile, as part of streamlining the German group’s manufacturing operations.