Search results for "FDA update"

Results 31 - 40 of about 55 for "FDA update".

CGM system approved for use without finger sticks

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,
October 2017

Device approved to treat diabetic foot ulcers

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.
January 2018

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

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

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

FDA urges patients to use caution when injecting insulin with pen needles

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.
October 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

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

Incretin mimetics' effects on pancreas under investigation

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
May 2013

New drugs approved for diabetes

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
November 2012

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