FDA issues novel nods for diabetes monitor, migraine lenses
The US FDA announced two De Novo marketing authorisations for novel medical devices this week: A continuous glucose monitor that also monitors Keytone levels from Abbott and a light-blocking lens for migraine sufferers from startup Avulux.
A new frontier in continuous diabetes monitoring
Abbott's Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System was granted a CE Mark in Europe at the end of May; it can now be sold in the United States as well. The system integrates with the existing Libre digital health ecosystem and the company hopes to integrate it with leading automated insulin delivery systems over the coming years.
"If glucose is the speedometer, ketones are like the check engine light — providing an alert that something may need attention," Chris Scoggins, executive vice president of Abbott's diabetes care business, said in a statement. "Libre Duo 10 Day brings both glucose and ketone levels together in a single dashboard, providing a more complete picture to help people with diabetes make more informed decisions."
Rising ketones can warn of a diabetic ketoacidosis (DKA) emergency, a diabetes complication that has been on the rise in recent years.
"Today’s authorization is a breakthrough for the safety of children and adults living with diabetes," Dr Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “Knowing that ketone levels are rising, and having that information in real time, around the clock, can be the difference between early intervention and a life-threatening emergency."
Guarding against migraines
Avulux's protective lenses use a precision optical filter indicated to block light at 480 nm (high blue range) and 590 nm (red/amber range), while allowing light in the remaining visible colour spectrum through, helping decrease the impact of light sensitivity in migraine sufferers without impairing their vision. The filter can be built into lenses, prescription or otherwise.
"For a long time, light sensitivity was seen as just a symptom of migraine. That thinking has changed," Dr. Charles Posternack, cofounder and CEO of Avulux said in a statement. "There is growing recognition that light sensitivity is a serious medical concern in its own right. This authorisation gives patients and providers a clear, FDA-recognised option designed specifically to manage the impact of light in those with migraine, one we hope will soon become the standard of medical care in this population."
The authorisation covers migraine patients aged 12 or older and allows the lenses to be sold over the counter. They are designed to complement, not replace, other avenues of migraine care or prescriptions.
Home health devices selected
Today the agency also announced the first two competitors accepted for its Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation Challenge. FDA plans to accept nine home health care devices under development to move onto an interaction phase where manufacturers will win access to early interaction with the agency as they continue to refine their products.
The first two selections are Epitel's REMI Neuro Monitoring Home Health Hub, a wireless wearable EEG system and Prapela's Therapeutic Vibrational Crib Mattress, a vibrating mattress designed to reduce the frequency, duration, and severity of hypoxemic and bradycardic episodes in infants with single-ventricle heart disease between surgeries.
Rumoured leadership changes
Finally, CNBC is reporting that the FDA has plans to introduce additional deputy commissioner posts to support new commissioner Heidi Overton, assuming she's confirmed by the Senate. According to the outlet, in addition to the existing deputy commissioner for food position, the agency plans to introduce a deputy commissioner for drugs and a deputy commissioner for technology, who would deal with both internal and external AI tools. Former Enzyme CEO Jared Seehafer is reportedly the frontrunner for the technology role.
