Small Sleep Sacks, Big Compliance Lessons: What FDA’s Happiest Baby Warning Letter Means for Device Manufacturers June 23, 2026 By Jennifer D. Newberger —

https://www.thefdalawblog.com/2026/06/small-sleep-sacks-big-compliance-lessons-what-fdas-happiest-baby-warning-letter-means-for-device-manufacturers/?utm_source=rss&utm_medium=rss&utm_campaign=small-sleep-sacks-big-compliance-lessons-what-fdas-happiest-baby-warning-letter-means-for-device-manufacturers On June 15, 2026, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Happiest Baby, Inc., the manufacturer of the SNOO Smart Sleeper bassinet system, following a July 2025 inspection of the company’s Los Angeles facility. The Warning Letter highlights several key points related to complaint handling, premarket notification requirements, field correction reporting, design changes, and unauthorized changes to the device’s intended use environment, with important lessons for device manufacturers of all sizes.

Ending birthright citizenship could be a public health disaster Health is not something that can be cordoned off by immigration status

https://www.statnews.com/2026/06/23/birthright-citizenship-supreme-court-ruling-public-health/ By Rachel E. FabiJune 23, 2026 Fabi is a public health ethicist at SUNY Upstate Medical University’s Center for Bioethics and Humanities. Sometime before the end of June, the Supreme Court is expected to deliver its...

The Catch-22 for disabled workers hidden in Medicaid’s new work requirements This single change could strip coverage from the very people the drafters claimed to protect

https://www.statnews.com/2026/06/23/medicaid-work-requirements-disability-medically-frail/ By Maria Town and Nicole JorwicJune 23, 2026 Town is the president and CEO of the American Association of People with Disabilities. Jorwic is the chief program officer at Caring Across Generations.

Cadence raises $100 million to automate chronic disease care with regulated AI The startup is in discussions with the FDA on using AI agents as part of its program to manage hypertension

https://www.statnews.com/2026/06/23/cadence-100-million-raise-automate-chronic-care-ai/ By Mario AguilarJune 23, 2026 Health Tech Correspondent Cadence, a digital health company that cares for patients with chronic conditions, has raised $100 million as it seeks to expand its footprint and automate the work of its clinicians with artificial intelligence.

Trump administration targets disability integration mandate in DOJ memo Memo runs counter to the long-standing position of helping people with disabilities live in their communities

https://www.statnews.com/2026/06/22/doj-memo-targets-disability-integration-olmstead-mandate/ By O. Rose BroderickJune 22, 2026 Disability in Health Care Reporting Fellow

Viewpoints: Public Health Figures In Political Arena Signal A Healthy Change; Should US Births Be Free?

https://kffhealthnews.org/morning-breakout/viewpoints-covid-public-health-figures-campaigning-are-a-healthy-change-should-us-births-be-free/

Study Finds Protein Structure Linked To Alzheimer's, Parkinson's

Study Finds Protein Structure Linked To Alzheimer's, Parkinson's Newsweek reports that experts have uncovered a way to help stop brain changes linked to Alzheimer’s and Parkinson’s disease by manipulating rather than eliminating a protein linked to cognitive decline. Other news is on aging, the gut microbiome, heat, and more. https://kffhealthnews.org/morning-breakout/public-health-062326/