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...]
New FDA Guidance on ‘Remanufacturing’ for Medical Devices
Summary: The Fda has issued remaining direction to clarify the definition of “remanufacturing” for reusable professional medical products needing upkeep or maintenance. This aims to distinguish remanufacturing from servicing, ensuring compliance with federal laws. The guidance … [Read more...]
Daylight Saving Ups Severity of Medical Malpractice Incidents
Medical malpractice incidents are more severe during the months of the year when daylight saving time is observed in the United States, according to a new study that examined three decades of malpractice claims. Results show that both medical malpractice incident severity and … [Read more...]