Friday Five: Abbott and Roche win FDA decisions as AI-device evidence gap draws scrutiny

Abbott received FDA authorization for Libre Duo 10 Day, described as the first wearable to continuously monitor both glucose and ketone levels. The device is intended to help detect rising ketones that can precede diabetic ketoacidosis, with a U.S. launch planned later in 2026.

Roche and Eli Lilly received FDA clearance for a blood test designed to help identify Alzheimer’s disease-related amyloid pathology in people aged 55 and older who have cognitive decline. Labcorp and Quest Diagnostics are expected to offer the test.

Roche also received FDA approval to expand its PATHWAY HER2 and VENTANA HER2 Dual ISH companion diagnostics for identifying patients with HER2-positive metastatic gastroesophageal adenocarcinoma who may be eligible for ZIIHERA.

A study in PLOS Digital Health found a major evidence gap among FDA-authorized AI/ML medical devices. Of 1,357 devices analyzed, only three had evidence evaluating patient-centered clinical outcomes; just 2.5% were linked to registered prospective trials.

The findings highlight that FDA authorization—often granted through predicate-based pathways—does not necessarily demonstrate clinical effectiveness, especially for vulnerable populations or real-world patient outcomes.

Separately, the FDA is seeking public feedback on how generative-AI medical devices should be regulated, including questions around monitoring, uncertainty, scope, adversarial behavior, and post-market evidence.