In December 2021, imtmedical ag, a subsidiary of Vyaire Medical, initiated a voluntary field correction for certain bellavista™ ventilators. With specific software version and configuration combinations, the ventilators can cease ventilation and generate a technical failure alarm 305. There is a potential issue with bellavista™ 1000 and 1000e ventilators that […]
Product/Vendor Updates
Sleep Cycle Offers Free Premium Subscription to College Students
Sleep Cycle announced that it will offer a 60-day free trial of its premium membership to current U.S. college students. Through this initiative, students will benefit from relaxing sleep sounds and stories library, including Sleep Cycle’s celebrity-narrated sleep story, “The Lighthouse” narrated by Emmy-award winning actor, Alexander Skarsgård. These sleep aids, […]
Sunrise Secures €6.5 Million in Funding for 3 Gram Chin Sleep Test
Sunrise, a health tech company founded in 2015 in Belgium, has just closed a €3.25 million fundraising round. Led by Kurma Partners, this round of financing, in which the Vives-IUF fund linked to UCLouvain and Namur Invest also participated, has the objective of launching and internationally marketing the company’s first […]
Somnoware Awarded FedRAMP Authorization, Top US Security Standard
Somnoware, a cloud-based platform for enhanced respiratory care management, announced that it has received Federal Risk and Authorization Management Program (FedRAMP) Agency Authorization through a Department of Veterans Affairs sponsorship. The designation authorizes Somnoware to work with Federal organizations and paves the way to complete the rollout of the Somnoware […]
FDA Clears First Contactless Respiratory Monitor for Smart Devices
Sound Life Sciences, a pioneer in contactless respiratory monitoring with its proprietary sonar software for consumer smart devices, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The privately-held telehealth startup’s smartphone or smartspeaker app produces inaudible ultrasonic sonar pulses to detect reflections caused […]
Bleep Wins $1.7M NIH Grant Award for PAP Innovation
Bleep, LLC. has been awarded a $1.7 million SBIR (Small Business Innovation Research) grant from the National Institutes of Health (NIH) to optimize positive airway pressure (PAP) mask design for use in home and acute care/hospital settings. Bleep, LLC hopes to add value in patient comfort and compliance with PAP […]
New UK HSAT AcuPebble SA100 Clears FDA
AcuPebble SA100, a small wearable device that enables automated, remote home testing to detect obstructive sleep apnea (OSA) in adults, has obtained FDA 510(k) clearance as a Class II medical device in the USA. The device, developed and commercialized by UK-based medical device company Acurable, builds on more than ten […]
FDA Grants the Hemolung De Novo Clearance
ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced that the Food and Drug Administration (FDA) has granted the Company De Novo clearance for the Hemolung Respiratory Assist System. The Hemolung System is the first and only […]
GE Healthcare Receives FDA Clearance for First X-Ray AI to Help Assess ET Tube Placement
GE Healthcare announced it has received Food and Drug Administration (FDA) 510(k) clearance for an artificial intelligence (AI) algorithm to help clinicians assess Endotracheal Tube (ETT) placements. The AI solution is one of five included in GE Healthcare’s Critical Care Suite 2.0, an industry-first collection of AI algorithms embedded on […]
FMCSA’s MRB Advises Current CPAP Trucking Guidelines Following Phillips Recall
Due to potential health risks, Philips Respironics voluntarily recalled certain continuous positive airway pressure (CPAP) machines over the summer. , the polyester-based polyurethane (PE-PUR) sound abatement foam runs the risk of breaking down and potentially entering the device’s air pathway. Under these circumstances, it is said that black debris from […]













