Outset Medical gets FDA nod for dialysis accessory months after halting sales
May 7, 2024
Outset paused shipments of its TabloCart with prefiltration last year after receiving a warning letter from the FDA.
Outset paused shipments of its TabloCart with prefiltration last year after receiving a warning letter from the FDA.
MyKidneyAI Becomes the Company’s Second Innovation to Recently Receive this FDA Distinction
The first fully implantable continuous glucose monitors can now be integrated with insulin pumps as part of an automated insulin delivery system
Sequel Med Tech will sell the new system, which integrates with Tidepool’s Loop insulin dosing algorithm.
The FDA’s decision allows people who don’t take insulin, including those who don’t have diabetes, to use the devices without a prescription.
Dexcom (Nasdaq:DXCM) announced today that the FDA cleared its Stelo glucose biosensor that does not require a prescription.
Glaukos (NYSE:GKOS) announced today that the FDA approved a New Drug Application (NDA) for its iDose TR implant.
Researchers at Case Western Reserve University and University Hospitals have identified an enzyme that blocks insulin produced in the body—a discovery that could provide a new target to treat diabetes.
Jeff Shuren, director of the Center for Devices and Radiological Health, said the test will give patients “more information about their health from the privacy of
their own home.”