The FDA recently approved a new indication for the Nova StatStrip Glucose Hospital Meter System, extending its use to critically ill patients who have been hospitalized. ... This is the first glucose meter cleared by the FDA for use in these patients.
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.
Lixisenatide (Adlyxin), a once-daily injection, was approved by the FDA on July 28 to improve glycemic control in adults with type 2 diabetes. ... In 10 trials of 5,400 patients, the glucagon-like peptide 1 receptor agonist improved HbA1c levels, both as
Aflibercept (Eylea) has received expanded approval to treat diabetic retinopathy (DR) in patients with diabetic macular edema (DME), the FDA recently announced. ... Aflibercept was previously approved to treat wet age-related macular degeneration and DME
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 benefits of the angiotensin-receptor blocker olmesartan continue to outweigh the risks for diabetic patients, according to the FDA. ... Overall, the FDA determined that the studies do not clearly show an increased cardiovascular risk and do not
The presence of an insulin pump should not preclude an appropriate and medically indicated CT scan, the FDA said. ... Clinicians should then communicate this information to the facility performing the scan, the FDA said.
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.
A new balloon device (the ReShape Dual Balloon) was recently approved by the FDA to treat obesity without invasive surgery. ... Six months after removal, treated patients had kept off an average of 9.9 pounds, according to an FDA press release.
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.