A continuous glucose monitoring (CGM) system was approved and some infusion sets were recalled, the FDA recently announced. ... Approval was based on a study comparing readings from the device to those obtained by an established laboratory method,
The FDA has permitted marketing of the Dermapace System, the first shock-wave device intended to treat diabetic foot ulcers, the agency announced on Dec.
The Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing medications is being eliminated, the FDA announced on Dec. ... ensure that the benefits of the drugs outweigh their risks, according to an FDA safety alert.
Continuous glucose monitoring system approved to direct therapy, but daily fingersticks still needed
20. In effect, patients and clinicians can use results directly from the device to make diabetes treatment decisions, according to an FDA press release. ... FDA, which also noted the potential for falsely raised glucose readings with acetaminophen use.
Dipeptidyl peptidase-4 (DPP-4) inhibitors may cause joint pain that can be severe and disabling, and some insulin pods may fail, the FDA recently warned. ... Dipeptidyl peptidase-4 (DPP-4) inhibitors may cause joint pain that can be severe and disabling,
The FDA provided recommendations to patients, caregivers, and clinicians on the proper use of both standard and safety pen needles to inject medicines in a Sept.
The system is the first approved to be used with other diabetes devices, such as automated insulin-dosing systems, insulin pumps, or blood glucose meters, according to the FDA. ... The FDA has approved marketing of the Dexcom G6 integrated continuous
The FDA has approved marketing of the first medical device to use artificial intelligence to detect diabetes-related eye problems, the agency announced on April 11.
The FDA is investigating reports of possible increased risk of pancreatitis and precancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes. ... The FDA has asked the researchers to provide the methodology used to collect and
The first generic version of pioglitazone hydrochloride (Actos) and a new indication for ranibizumab injection (Lucentis) were recently announced by the FDA. ... In addition, ranibizumab injection (Lucentis) received FDA approval for a new indication to