Search results for "FDA update"

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FDA warns about smartwatches, rings to measure glucose

Smartwatches and smart rings that claim to measure blood glucose levels without piercing the skin are being sold commercially, but none have been approved by the FDA, the agency warned.
8 Mar 2024

First over-the-counter CGM cleared for marketing

The integrated continuous glucose monitor (CGM) is intended for anyone ages 18 years and older who does not use insulin.
8 Mar 2024

Two diabetes drugs go generic

A dipeptidyl peptidase-4 inhibitor and sodium-glucose cotransporter-2 inhibitor recently had first-time generic versions approved.
10 Nov 2023

CGM software authorized, infusion sets recalled, tirzepatide approved for obesity

The FDA cleared a software system that works with continuous glucose monitors (CGMs) and insulin pumps for marketing and announced the recall of some lots of insulin infusion sets.
8 Dec 2023

CBT device for type 2 diabetes receives OK to market

The FDA recently authorized marketing of a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy (CBT) to adult patients with type 2 diabetes.
11 Aug 2023

Diabetes device recalled due to risk of fire

The FDA recently announced a class I recall of the Omnipod DASH Insulin Management System Personal Diabetes Manager due to reports of battery issues, including battery swelling, fluid leakage, and extreme overheating that may pose a fire hazard.
9 Dec 2022

Bionic pancreas cleared for patients with type 1 diabetes

The new automated insulin dosing system, called the iLet Bionic Pancreas, is intended for use in patients ages 6 years and older with type 1 diabetes.
9 Jun 2023

New safety alert for certain continuous glucose monitoring systems

Glucose readers in the FreeStyle Libre product family have the potential for battery swelling and overheating if not properly stored, charged, or used.
14 Apr 2023

Ertugliflozin approved as adjunct treatment for type 2 diabetes

As an adjunct to diet and exercise, the drug was approved as monotherapy and for use in fixed-dose combinations with metformin or sitagliptin.
12 Jan 2018

First AI device approved to detect diabetes-related eye problems

The software analyzes images of the eye taken with a retinal camera and offers one of two results: “more than mild diabetic retinopathy detected: refer to an eye care professional” or “negative for more than mild diabetic retinopathy; rescreen in 12 months.”
11 May 2018

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