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.

The US FDA has issued a Form 483 to Granules India, with six observations, spanning document and vent mismanagement to bird droppings and rust.

Miplyffa (arimoclomol) was approved for Niemann-Pick disease type C when administered with another high-priced drug used off label as standard of care for about 80% of NPC patients. 

A Phase III trial with oral deucrictibant is underway for treatment of acute hereditary angioedema attacks, while the Swiss firm will begin a Phase III trial in prophylaxis later this year.