By Alyx Arnett Software is no longer just a tool in healthcare—it’s becoming a medical device in its own right. Known as software as a medical device, or SaMD, this technology is playing a growing role in diagnosing and treating conditions, with more companies, including those in … [Read more...]
BMC Medical Highlights Telemedicine and AI in Sleep Care at ERS Congress
Summary: At the European Respiratory Society Congress, BMC Medical Co highlighted its PAP Link telemedicine solution and new advancements in sleep and respiratory healthcare, focusing on how AI and digital health can enhance patient outcomes and improve the efficiency of positive … [Read more...]
Industry Veteran Appointed CEO of Performance Home Medical
Summary: Performance Home Medical (PHM), a provider of home medical equipment and respiratory services, has appointed Larry Mastrovich as its new CEO following an investment from Grant Avenue Capital. The appointment reflects PHM’s focus on expanding its services, growing its … [Read more...]
XII Medical Raises $45M to Advance Neuromodulation Therapy for OSA
Summary: XII Medical Inc, a clinical-stage medical technology company focused on developing neuromodulation therapies for obstructive sleep apnea (OSA), has raised $45 million in Series B equity financing. The funding, led by Omega Funds with participation from new and existing … [Read more...]
FDA Seeks Input on Advancing Health Equity in Medical Devices
Summary: The FDA’s Center for Devices and Radiological Health (CDRH) has published a discussion paper titled “Health Equity for Medical Devices” and is seeking public input to advance health equity in the medical device sector. The paper outlines considerations for designing … [Read more...]
Inspire Therapy Meets New EU Medical Device Standards
Summary: Inspire Medical Systems has achieved CE mark certification under the European Union’s updated Medical Device Regulation (EU MDR) for its sleep apnea treatment, Inspire therapy. This certification ensures compliance with the EU’s more stringent requirements, allowing … [Read more...]
Inspire Medical Implantable Pulse Generator Recall
By Sree Roy Sleep professionals are understandably anxious about product recall notices in the wake of the long-lasting negative impacts of the CPAP recall by Philips Respironics. But I predict that the recent recall of Inspire IV implantable pulse generators will ultimately be … [Read more...]
Natus Appoints Veteran Medical Device Leader as New CEO
Summary: Natus has appointed Chris Landon as its new CEO. Landon brings over two decades of experience in the medical device industry, focusing on image-guided therapy devices, cardiology, and neurodiagnostics. He previously held executive roles at Philips and Medtronic and … [Read more...]
Dream Sock for Infant Monitoring Snags UK Medical Certification
Summary: Owlet Inc., a smart infant monitoring company, has received UKCA certification for its Dream Sock, following recent CE Mark certification. These certifications allow Owlet to expand its reach in key UK and European markets. Dream Sock, which wraps around a baby’s foot to … [Read more...]
Nox Medical Establishes Canadian Presence With New Location
Summary: Nox Medical has launched Nox Medical Canada Inc., marking its first physical presence in Canada to streamline the distribution of sleep testing equipment. This expansion follows significant growth in sleep diagnostic sales in 2023 and aims to enhance logistics and … [Read more...]