Summary: Movano Health, which is pursuing FDA clearance for its EvieMED Ring, recently received additional clarifying questions from the FDA regarding the medical aspects of the device. This marks the final phase of the company’s 510(k) application review process. Movano says it … [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...]
New Study Seeks to Explain Why Some Babies Are More Vulnerable to SIDS
Summary: A European research group has proposed a new model to explain sudden infant death syndrome (SIDS), focusing on the balance between infants’ protective factors and developmental challenges. Published in Human Nature, the study highlights how infants develop protective … [Read more...]
Global Survey Seeks Insights on Parkinson’s Impact on Sleep
PD Avengers, an alliance of more than 7,000 people and 150 partner organizations in 98 countries affected by Parkinson’s disease, launched a Surveying Late Evening Effects of Parkinson’s (SLEEP) survey to delve into the often-overlooked realities of how Parkinson’s disease … [Read more...]