Category: Laws & Regulations

Laws & Regulations

FDA Clears Zeto New Wave for Outpatient Routine EEG

The EEG system features a 21-electrode setup and cloud connectivity to help clinics address staffing shortages and expand access to neurodiagnostics.

Laws & Regulations

FDA Clears Nylon Oral Appliance with Single-Point Midline Advancement

The device, cleared for mild to moderate OSA, is available immediately. PDAC coverage is pending.

Laws & Regulations

Beware of Compounded Tirzepatide

Tirzepatide copycats have implications for the safety of patients seeking treatment for obesity and obstructive sleep apnea.

FDA

FDA Seeks Input on Advancing Health Equity in Medical Devices

The FDA's Center for Devices and Radiological Health has released a discussion paper and is soliciting public feedback to enhance health equity in the context of medical devices.

Patient Rights, Privacy

Lawsuit Alleges Secret Bathroom Videotaping at Sleep Disorders Center

The lawsuit claims that hidden cameras were placed in restrooms at a New York sleep disorders center, capturing patients, staff, and visitors without their knowledge.

Medicare & Medicaid

Medicare Advantage Plan Adds Oura Ring to Member Benefits

Starting in 2025, certain Essence Medicare Advantage members will have the option to receive a complimentary Oura Ring and a subscription to the Oura App.

Fraud & Malpractice

California Man Sentenced to Prison for $1.5M Sleep Study Fraud Scheme

A former Fresno sleep clinic owner was sentenced to nearly four years in prison for fraudulently billing Medicare and Medi-Cal for thousands of sleep studies that were never performed on patients.

Financial

Oral Appliance Maker ProSomnus Rebounds with Strong Performance After Bankruptcy Filing

ProSomnus Sleep Technologies reported record Q2 revenues as it emerges from Chapter 11 bankruptcy reorganization.

Commercial Transportation

The Probable Cause of Cindy B Maritime Accident Is Sleep-Related

The National Transportation Safety Board published its accident report on the contact of Cindy B tow with a dock in Oregon.