Abbott Cleared the First Dual Glucose and Ketone Sensor. FDA Judged Accuracy, Not Admissions.
The label says diabetes. The clinical argument is type 1. Coverage conversations start from 2.1 million people, not 40.1 million.
De Novo
Avulux Won a De Novo and Created the Category Its Competitors Will File Into
Going first through a De Novo builds the road behind you. Avulux owns the claim today and has created the category rivals will file 510(k)s into.
Two FDA Device Authorisations, Two Sets of Evidence Narrower Than the Headline
Aletta matches human phlebotomists only when it agrees to attempt a draw. Narwhal cleared on bench and animal data, citing a trial with a different probe.
J&J Built Its Surgical Robot Into the Table, and Aimed It at the 92% of Surgery That Isn’t Robotic
The FDA granted De Novo authorization to OTTAVA, the first surgical robot with arms built into the operating table, cutting the footprint by up to half.
Randox Gains FDA De Novo Clearance for Hemophilia CDx
Randox Laboratories has secured FDA de novo clearance for its ConcizuTrace ELISA companion diagnostic, designed to quantify plasma concentrations of Novo Nordisk’s recently approved hemophilia treatment Alhemo (concizumab-mtci). The regulatory milestone comes just weeks after Alhemo received FDA approval in December 2024 as a once-daily prophylactic injection for adults and pediatric patients 12 years and … Read more