Topic: artificial pancreas
Beta Bionics received FDA approval for home-use studies of a bionic pancreas that uses AI to vary insulin doses in Type 1 diabetes.
The clearance marks the first time the FDA has signed off on such an integrated system and creates a simpler path to market for future CGMs.
Cam Med is working on a patch pump as an alternative to traditional insulin pumps in "artificial pancreas" systems.
Disclosure of the round comes six months after midphase data positioned Beta Bionics to look forward to a pivotal trial of its diabetes device.
CMS covers traditional insulin pumps, but not tubeless patch pumps, causing concern around innovation as well as patient access.
The series B gives Bigfoot the financial muscle to move its automated insulin infusion device into a pivotal clinical trial in the U.S. next year.
Medtronic’s sales took a 4% hit in the second quarter, but the company expects growth to ramp back up in H2.
Lilly is working on devices that move it onto Medtronic’s turf and has teamed up with Dexcom to add continuous glucose monitoring to its arsenal.
Here's Monday's dose of medtech news of note.
The FDA OK'd Abbott’s FreeStyle Libre Flash glucose-monitoring system, which does not require fingerprick calibration.