As of this week, consumers can order Dexcom Inc.’s Stelo continuous glucose monitor (CGM) online without a prescription, making it the first to hit the market. Dexcom will have competition soon, however, with Abbott Laboratories planning to roll out its over-the-counter Lingo and Libre Rio CGMs in short order. Read More
The U.S. FDA caught up with four makers of CPAP cleaning machines in the form of warning letters advising the manufacturers that the claims made for their systems fall under the definition of a regulated medical device. In two of these warning letters, the FDA said it had been in touch with the manufacturer for at least two years, indicating that the agency has been steadily working on enforcement activities in this space for some time. Read More
Telix Pharmaceuticals Ltd. filed an NDA with the U.S. FDA for its radiopharmaceutical glioma imaging product, TLX-101-CDx (Pixclara, 18F-floretyrosine, 18F-FET), for the characterization of progressive or recurrent glioma from treatment-related changes in both adult and pediatric patients. Read More
Since the publication of The Hallmarks of Aging in 2013, aging research has exploded. The field now has more than 300,000 articles on the biological signals of the effect of time on the body. What would Marty McFly, the legendary character from the Back to the Future saga who traveled with his DeLorean time machine from the ‘80s to the ‘50s, think if he visited 2024 and saw laboratories experimenting with techniques to turn back the biological clocks of cells or increase the lifespan of rejuvenated mice? Read More
In what represents the first patenting from Munich, Germany-based Meliodys Medical UG, its co-founder and chief executive officer Simone Sabbione describes their development of a hormone-free, local pain management approach for treating dysmenorrhea, which aims to address the condition while minimizing the occurrence of side effects. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amra Medical, Augere Medical, Femasys, Renata Medical, Oxiwear. Read More
