A Heart Valve That Grows with Kids, a Cuffless BP Ring & AI That Learns
Allison Komiyama and Michael Nilo host this week’s Trying to Keep Up without a guest. Their conversation moves from new device decisions to emerging AI policy, with a recurring question: how can regulators make room for useful technology while protecting patients?
The episode’s standout approval is the Autus Size-Adjustable Valve, a pediatric pulmonary valve designed to be widened as a child grows. Michael explains why an adjustable valve could matter for children who might otherwise face repeat procedures. Allison points to the incentives available for pediatric device submissions.
They also discuss Happy Health’s ring, cleared for passive blood pressure measurement without a cuff, and the challenge of evaluating wearable data that people may use to make health decisions. ProNova’s VIRTUE QA prompts a deeper discussion: its authorized predetermined change control plan permits daily, machine-specific AI retraining, with automated checks before a revised model goes live. Allison and Michael consider what that approach could mean for adaptive medical AI.
Additional topics:
Device identification: BridgeSource Medical’s SmartRead™ concept could help identify an implanted cardiovascular electronic device. The hosts note that publicly available details are limited and discuss potential cybersecurity concerns.
Women’s health: The Juveena® Hydrogel System is intended to reduce the incidence and severity of intrauterine adhesions following a specified procedure. Michael flags that his explanation of how the hydrogel works is an inference.
Mobility and mental health: Eve, a self-balancing exoskeleton, and Motivista, a digital therapeutic for negative symptoms of schizophrenia.
Breakthrough designations: HeartBeam’s at-home heart attack assessment technology, SeaStar Medical’s device for hyperinflammation in adults with sepsis or septic conditions, and Abbott’s deep brain stimulation system for treatment-resistant depression.
Ways to participate: Nominations for FDA advisory committees and public comments on the FDA’s generative AI discussion paper, due October 19, 2026.
AI policy abroad: The hosts discuss the UK’s work on a healthcare AI regulatory framework.
October 22 Webinar: Allison and Kenneth Civello, MD, MPH will be speaking on The Quantified Self Revisited: What Can Wearable Data Really Tell Us?
RegulatoryAF Conference: “It’s not a conference. It’s an experience.” Early bird registration ends November 30, 2026.
