Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies to treat obstructive sleep apnea (OSA) and related disorders, announced positive topline results from the MARIPOSA Phase 2b trial, an efficacy, safety and dose-finding study of one-month duration. The topline results were positive for the company’s lead candidate for […]
Clinical Insights & Research
Certain Philips Respironics Masks Recalled Due to Safety Issue
The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that Philips Respironics (Philips) recalled certain masks used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines due to a serious safety concern. The […]
Certain Philips Respironics BiPAP Machines Recalled
The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that Philips Respironics (Philips) recalled certain bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines that may contain a plastic contaminated with a non-compatible material. If that plastic is in the […]
Panthera D-SAD Classic Oral Appliance Now Eligible for Medicare Reimbursement
Panthera Dental has received notification from the Pricing, Data Analysis and Coding (PDAC) contractor, following their request for a coding decision for the Panthera D-SAD Classic oral appliance. PDAC, following a formal review and assessment, has classified the HCPCS code (Healthcare Common Procedure Coding System) E0486 to be used when […]
Bfit Releases New Spring-Driven Dynamic Oral Appliance
We are pleased to announce the latest addition to the family of Great Bfit oral appliances for sleep apnea, snoring, and bruxism. Bfit Sleep, LLC is announcing the addition of the REMflx (pronounced REM FLEX) spring-driven dynamic oral appliance. This appliance uses the same great technology as the Bfit Sleep […]
Vivos Announces Regulatory Clearances for Oral Appliances in Australia
Vivos Therapeutics, Inc. announced that it has received multiple Class I clearances by the Therapeutic Goods Administration for multiple indications to include the treatment of snoring and obstructive sleep apnea (mild, moderate and severe) for both adults and children for its series of oral appliances. “These recent clearances provide further validation […]
Apnimed Sleep Apnea Pill Granted FDA Fast Track Designation
Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic treatments to address obstructive sleep apnea (OSA) and related disorders, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its oral pharmacologic AD109 for the treatment of OSA. “Fast Track designation is a significant […]
Recall: Dräger SafeStar 55 Breathing System Filters
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: SafeStar 55 Breathing System Filter Product Model Numbers: MP01790 Lot Number: LT2103 Devices Recalled in the U.S.: 35,950 Dates distributed: […]
FDA Temporarily Yanks Juul from U.S. Market
The American Thoracic Society applauds the FDA’s decision to remove Juul products from the U.S. marketplace. This decision is long overdue. “Juul is one of the most popular e-cigarette products among middle and high school kids,” said Hasmeena Kathuria, MD, chair of the ATS Tobacco Action Committee. “Their flavored products are particularly […]
Nocturnal Bruxism Can Be a Headache, New Solution for Migraine Pain
By Jason Tierney What goes bump in the night can result in significant pain in the daytime. New research has been published demonstrating the effectiveness of the Nociceptive Trigeminal Inhibition Tension Suppression System, or NTI-tss Plus, in significantly reducing medically diagnosed migraine pain. The device is worn during sleep and […]













