Category: Laws & Regulations

Laws & Regulations

Combo CPAP/Filter Mask by Circadiance Gets FDA Emergency Use Authorization

The product is a CPAP mask that was modified by combining it with an N95.

NTSB Chair: “Hours of Service Rules Are Somewhat Complex, But Sleep Science Is Not”
Fatal Multivehicle Crash Likely Caused in Part Due to Undiagnosed Sleep Apnea, Reports NTSB
Wearable Restless Legs Syndrome Therapy Granted FDA Breakthrough Device Designation
These Sleep Medicine Products Got FDA Nod in 2019
Somnetics Gets FDA Emergency Use Authorization for BiPAPs and Respiratory Circuits
Vanda to Resubmit FDA Application for HETLIOZ for Sleep Disturbance in Patients with Smith-Magenis Syndrome

Laws & Regulations

“Unprecedented Demand”: Sleep Medicine Scales Its Remote Offerings

Telemedicine appointments and drop-shipped home sleep tests surge during the pandemic. Some predict these changes may be incorporated into a new normal.

Laws & Regulations

Mylan Launches Generic of Nuvigil Tablets

Mylan NV on June 1 announced the US launch of Armodafinil tablets, 50 mg, 150 mg, 250 mg, a generic version of Cephalon’s Nuvigil. Mylan received final approval from the Food and Drug Administration (FDA) for its...

FDA

FDA Warning Letter: EPAP Mask Maker Is Misbranding Its Snoring Device

CPAPNEA Medical Supply has a cleared 510(k) for the Optipillows EPAP mask for the sole intended use of alleviating snoring during sleep in adults, states the FDA in a warning letter.Your device is misbranded under section...

Patient Rights, Privacy

Handling the Inevitable Sleep Lab Patient Selfie [Editor’s Message]

Why you should enact a photo/video policy in your sleep disorders center.

Medicare & Medicaid

CMS: Oral Appliances Made from Digital Scans Now OK for Medicare Beneficiaries

After requests from dental sleep medicine practitioners, the Centers for Medicare and Medicaid...

Fraud & Malpractice

Medical Malpractice Insurer: Inadequate Pre-Op Assessments Create Risks for Anesthesiologists

When reviewers identified inadequate histories and physicals, 67% of those patients were found to...

Financial

ResMed to Pay $37.5 Million to Settle False Claims Act Violation Allegations

ResMed Corp has agreed to pay more than $37.5 million to resolve False Claims Act violation allegations. ResMed denies that it violated the law. The US Department of Justice (DOJ) alleged that ResMed paid kickbacks to durable...

Commercial Transportation

Wearable Tech That Tells Drowsy Truckers It’s Time to Pull Over

Biometric sensors are getting lighter, cheaper and more accurate, and could help warn drivers before they become too fatigued, reports The New York Times. New wearable technology monitors the drivers but in a more subtle way,...