Medical design firm, Nectar Product Development, and its affiliated medical device company, BreathDirectTM, announced that its BDR-19TM ventilator has received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA). Approval of the BDR-19TM for the critical care of patients with ventilatory insufficiency comes after an extended review process by FDA regulators […]
Sleep Disorders
Breas Introduces New Vivo 45 LS Ventilator to the U.S.
Breas Medical USA has announced the market introduction of the Vivo 45 LS, one of the smallest, full-featured life support devices on the market. The Vivo 45 LS is cleared by the FDA to provide both invasive and non-invasive continuous or intermittent ventilatory support across the continuum of care in […]
FDA Update on Ventilator Splitters
The U.S. Food and Drug Administration (FDA) is informing health care providers and health care facilities about up-to-date information concerning multiplexing ventilator tubing connectors, also known as ventilator splitters, in situations in which no alternatives for invasive ventilatory support are available. Although the FDA has not received any adverse event […]
PortPatch, First N99 Filter Patch for PAP Devices
Azimuth Sleep Solutions has received FDA Emergency Use Authorization (EUA) for their patent-pending PortPatch™ product, in order to expand air filtration capabilities for patient treatment options and to help keep healthcare workers safer in patient-care areas where non-invasive ventilatory treatment devices need to be used. PortPatch™ is made with hydrophobic, […]
Melatonin Produced in the Lungs Prevents Infection by Novel Coronavirus
The hormone acts as a barrier against SARS-CoV-2, blocking the expression of genes that encode proteins in cells serving as viral entry points, according to a study by researchers at the University of São Paulo. Melatonin synthesized in the lungs acts as a barrier against the virus, preventing expression of […]
First Patient Dosed in Second Phase 2 Clinical Trial of Oral OSA Medication
Apnimed, a clinical-stage pharmaceutical company focused on developing oral medicines to treat Obstructive Sleep Apnea (OSA) and related disorders, today announced that the first patient has been dosed in a Phase 2 clinical trial evaluating AD109 as a treatment for mild to moderate OSA. If successful, AD109 could offer an […]
Wellinks Announces IRB Approved Study of COPD Digital Health Solution
Wellinks, a leader in innovative respiratory technologies, has announced the initiation of an IRB approved research pilot study for patients previously diagnosed with COPD. The study, led by primary investigator Dr. Brian D. Gelbman, Associate Clinical Professor of Medicine at Weill Cornell Medical College and New York Presbyterian Hospital, will […]
Dräger Extends Ventilation Solutions Into U.S. Long-Term Care Facilities Through Breas Medical Distribution Agreement
Dräger announced that it has entered into an agreement with Breas Medical, a global medical device company delivering respiratory care solutions throughout the continuum of care. Together, they will provide long-term acute care (LTAC) and skilled nursing facilities (SNF) in the U.S. access to both Dräger and Breas Medical mechanical […]
BreathDirect Passes UL Independent Testing for Low-Cost, U.S. Built BDR-19 Ventilator
California-based medical device company BreathDirectTM, developers of an affordable, full-service ventilator designed in response to COVID-19, announced that Underwriters Laboratory, the world’s largest independent testing organization, has completed testing of the BDR-19©, evaluating its safety and performance to treat ventilatory insufficiency. UL determined that the BDR-19© meets the criteria established in the […]
Philips New DreamWear Silicone Pillows Designed Using 3D Facial Scan Data
Royal Philips introduced DreamWear Silicone Pillows to the innovative DreamWear system of masks in North America. The all-silicone pillow cushion was designed using data from thousands of 3D facial scans to anatomically conform to fit and seal various nostril shapes and sizes across populations. Aiming to address mask refit and therapy adherence […]











