EU MDR Challenges Spark Questions

HungeroTrial’s Antal Solyom highlights the overwhelming amount of re-certification applications, noting that some notified bodies are not even accepting new device applications.

Is a New Competitor to Elon Musk’s Neuralink Waiting in the Wings?

Brain Computer Interfaces (BCI) Study Helps Voiceless Woman Communicate: Recently, researchers published a study in Nature reporting that a 68-year-old woman with amyotrophic lateral sclerosis (ALS) — their sole research subject — now has the ability to “talk to text” through two (2) small implants with about 120 electrodes that penetrate her brain and monitor neural activity.

Eye-Tracking Device Could Be More Accurate Test for Autism in Toddlers

Promising results seen with eye-tracking tool for autism diagnosis: A study found that the EarliPoint Evaluation demonstrated high sensitivity and high specificity in predicting expert autism diagnoses. The eye-tracking technology requires children to watch a 10-minute video as it takes eye movement measurements.

After a lifetime together, surviving spouses can be vulnerable in grief

Spousal loss may come with significant health effects: Grief over the loss of a lifelong partner can take a serious emotional and physical toll on the surviving spouse, though health impacts vary from person to person. Sociologist Deborah Carr says social support is the most important resource for navigating grief, and recent research has shown that spousal loss tends to be harder on men and those who are widowed at a younger age. Carr says men may have a more difficult time because many have lost the person who cooks for them and reminds them to take care of their health.

Medtronic weighs in on GLP-1 (glucagon-like peptide-1) impact for device manufacturers

Medtronic is the latest and largest device manufacturer to forecast how drugs such as Ozempic and Wegovy will affect demand for medical devices. With the weight loss drugs already taking a bite out of bariatric procedure volumes, CEO Geoff Martha offered Medtronic’s perspective on the impact for its surgical and diabetes businesses