Search results for "FDA update"

Results 11 - 20 of about 58 for "FDA update".

First AI device approved to detect diabetes-related eye problems

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.
May 2018

First continuous glucose monitoring system approved to be used with other devices

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
April 2018

New daily injection approved for adults with type 2 diabetes

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
August 2016

Aflibercept approved for diabetic retinopathy in diabetic macular edema

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
April 2015

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.
January 2017

Olmesartan passes safety review

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
July 2014

Safety alert and advice on CT scanning in patients with insulin pumps

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.
April 2016

New weight loss device approved

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.
August 2015

Rosiglitazone REMS ends, new insulin approved

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.
January 2016

Warning on DPP-4 inhibitors and insulin recall

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,
September 2015

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