Wave’s Public Comment on the FDA’s Request for Feedback on Generative Artificial Intelligence-Enabled Digital Mental Health Medical Devices.
We submit the following comments to support a regulatory framework that ensures patient safety while enabling responsible and equitable innovation.
Tool Calling is the Real Safety Feature
Most evaluation frameworks focus on whether a model says the right thing when it encounters suicidal ideation. That’s a start, but it’s not enough. The evaluation needs to test what happens next: how the model uses tool calls to take action, route information, or trigger the right workflow. That’s what actually determines safety.
Simulation is the Lab: Building Safe, Measurable AI for Mental Health Care
To earn trust in mental health care, AI must be tested safely and measured transparently, just like self-driving cars. Wave CTO Ryan Weald explains why large-scale simulation and shared benchmarks are the key to building responsible, effective mental health AI.
Wave Life’s Coaching Model Delivers Clinically Significant Mental Health Gains, Not Just for Subclinical Presentations
New peer-reviewed research published in JMIR Formative Research confirms that Wave Life’s coaching-first model drives rapid, measurable improvements in anxiety, depression, and stress—often within 30 days. The study shows that evidence-based coaching can deliver clinically significant outcomes at scale, even for individuals with severe symptoms.
From Stress to Sustainable Wellbeing: The Power of a Dedicated Coach
Learn why quick fixes don’t solve workplace stress and how a dedicated mental-health coach helps employees build lasting resilience, engagement, and wellbeing.
Why Care Navigation Is the Missing Piece in Workplace Mental Health
Most workplace mental health programs stop at access. True care navigation keeps employees supported, guided, and improving. Here’s how Wave builds it in from day one.
The Overlooked Role of Coaches in High-Acuity Mental Health Support
Coaching isn’t just for “wellness.” Learn how trained, supervised mental health coaches deliver real outcomes for high-symptom users and why employers and health plans should take note.
Measuring What Matters: How to Know If Your Mental Health Program Works
Learn how to measure mental health program success. Go beyond utilization and see why symptom tracking and outcomes prove real ROI.
From Empathy to Evidence: How Wave Ensures Coaching Quality at Scale
Learn how Wave ensures coaching quality at scale with Coach U, clinical supervision, and outcomes-driven care to help employees feel better faster.
FAQ: Can Wave Support Menopause, GLP-1s, and Other Trending Health Themes? Yes—Here’s How
Employers don’t need a new vendor for every workforce health trend. See how Wave’s transdiagnostic coaching model adapts to menopause, GLP-1s, caregiving, and beyond—with outcomes that prove ROI.
“Personalized” Mental Health Support? Not So Fast.
Learn why most “personalized” mental health solutions fall short and what real personalization looks like for employees, health plans, and beyond.
From Stress to Chronic Conditions: Why Mental Health Support Can’t Be One-Size-Fits-All
Employee mental health spans stress to chronic conditions. Learn why flexible, personalized support models outperform one-size-fits-all approaches.
Inside Wave’s Coach University: Raising the Bar for Mental Health Coaching
Most coaching platforms rely on gig workers with no standards. Wave’s Coach University develops NBHWC-certified coaches through rigorous training, clinical supervision, and a proven transdiagnostic model—driving engagement, outcomes, and ROI.
How Continuous Outcomes Tracking Separates Wave From Traditional EAPs
Wave replaces lagging, utilization-only EAP reporting with continuous outcomes tracking that proves ROI and drives employee wellbeing.
Why Employees Aren’t Using Your EAP but Will Use Coaching
Traditional EAPs have 2–5% engagement. Coaching is 5x higher. Here’s why employees avoid EAPs—and how Wave fixes the problem.
What Makes a Great Mental Health Coach? (Hint: Training Matters)
Employers are investing in mental health coaching. But not all coaching is created equal. Learn what separates high-quality coaching from generic wellness apps and how Wave sets the standard.
What Is Measurement-Based Care (and Why HR Leaders Should Care)
Traditional EAPs track usage. Measurement-based care tracks outcomes. Discover why that distinction matters—and how Wave proves ROI for your mental health benefits.
Can You Trust AI in Mental Health? What Employers Should Know
AI in mental health is booming, but can you trust it? Learn how Wave combines AI and human care to deliver real outcomes, safely and at scale.
Can Wave Support Menopause, GLP‑1s, Neurodiversity & More Workforce Health Trends? Yes—Here’s How
Wave supports menopause, GLP‑1s, neurodiversity, and more with one scalable care model that adapts as health trends evolve—no extra vendors required.
What Does “Whole-Person Mental Health” Really Mean in the Workplace?
Whole-person mental health is more than a buzzword. Learn what it really means, why traditional EAPs fall short, and how Wave’s coaching-first model delivers measurable ROI.

