Apr 14,2023

FDA CLEARS READER FOR ABBOTT'S FREESTYLE LIBRE® 3 SYSTEM

Abbott today announced that the U.S. FDA has cleared a reader for its FreeStyle Libre® 3 integrated continuous glucose monitoring (iCGM) system. With the FDA's clearance of a standalone reader, Abbott is working to get the FreeStyle Libre 3 system added to Medicare's list of covered systems as soon as possible.

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Mar 02,2023

Bigfoot Biomedical Receives FDA Clearance for Bigfoot Unity® Android App for People Living with Insulin-Requiring Diabetes

Bigfoot Biomedical today announced the U.S. Food and Drug Administration has issued 510(k) clearance for the Android version of the Bigfoot Unity® Mobile App, a necessary component of the Bigfoot Unity® Diabetes Management System. The Bigfoot Unity System is the first and only FDA-cleared smart injection system that turns continuous glucose management (CGM) data into insulin dosing advice displayed right on the pen cap for people using multiple daily injection therapy. “Most Bigfoot Unity users live with type 2 diabetes and are part of a demographic that is even more likely to use Android devices than the general U.S. population," said Jeffrey Brewer, CEO of Bigfoot Biomedical.

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Mar 06,2023 TOP STORY

U.S. FDA Clears Abbott's FreeStyle Libre® 2 and FreeStyle Libre® 3 Sensors for Integration with Automated Insulin Delivery Systems

Abbott today announced that the U.S. Food and Drug Administration has cleared its FreeStyle Libre 2 and FreeStyle Libre 3 integrated continuous glucose monitoring system sensors for integration with automated insulin delivery (AID) systems. Abbott modified the sensors to enable integration with AID systems. AID systems help people manage daily diabetes care by automatically adjusting and administering the insulin delivered by an insulin pump based on real-time glucose data from their FreeStyle Libre 2 or FreeStyle Libre 3 sensors. The company is partnering with Insulet and Tandem for future integrations in multiple countries, including the U.S. Outside the U.S., Abbott's FreeStyle Libre 3 sensor is already authorized to work with the mylife™ Loop solution from Ypsomed and CamDiab in Germany, with additional launches in the UK, Switzerland and the Netherlands planned for the first half of this year.

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Feb 28,2023

Theranica’s Nerivio® Cleared by FDA for Preventive Treatment of Migraine

Theranica today announced that the Nerivio® prescription wearable recently received Food and Drug Administration (FDA) clearance as a dual-use acute and preventive treatment for migraine with or without aura in people 12 years of age or older. In a randomized placebo-controlled study, the drug-free Nerivio, used every other day, demonstrated significant reduction in monthly migraine days and other prevention endpoints.

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Feb 03,2023

Tidepool Loop automated insulin delivery system wins FDA clearance

Tidepool announced recently that the FDA cleared its Tidepool Loop, a “do-it-yourself,” (DIY) automated insulin delivery (AID) system. Tidepool designed Tidepool Loop for the management of type 1 diabetes in people with diabetes six years of age or older. It has compatibility with the Apple Watch, according to the company’s website. According to a news release, the algorithm works with compatible integrated CGMs and alternate controller-enabled (ACE) pumps.

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Jul 22,2015

Propeller Health Receives FDA Clearance for the Propeller Platform in Association with Boehringer Ingelheim’s Respimat® Inhaler and GlaxoSmithKline’s Diskus® Inhaler

Propeller Health, the FDA-cleared digital health solution for chronic respiratory disease, today announced U.S. Food and Drug Administration 510(k) clearance to market its Propeller platform in association with medications using GlaxoSmithKline’s Diskus® dry powder inhaler (DPI) device for asthma and chronic obstructive pulmonary disease (COPD). This new clearance follows 510(k) clearance to market the Propeller platform in association with medications using Boehringer Ingelheim’s Respimat® inhaler for chronic obstructive pulmonary disease (COPD) received in March 2015.

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Mar 26,2020

Pear Therapeutics Obtains FDA Authorization For Somryst, A Prescription Digital Therapeutic For The Treatment Of Adults With Chronic Insomnia

Pear Therapeutics, Inc. today announced the U.S. Food and Drug Administration (FDA) has granted authorization for Somryst™, the first prescription digital therapeutic (PDT) intended for use in the treatment of patients 22 years of age and older with chronic insomnia. Somryst treats patients with chronic insomnia by improving a patient’s insomnia symptoms, and it is the first product submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed as part of FDA’s Software Precertification Pilot Program to help build and test FDA’s Digital Health Precertification Working Model 1.0.

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Apr 14,2020

FDA Grants The Learning Corp Breakthrough Device Designation for Speech Therapy App

The Learning Corp, an award-winning digital therapeutics provider, today announced that it has received Breakthrough Device designation from the United States Food and Drug Administration (FDA) for its Speech Therapy (ST) App, which is designed to provide accessible cognitive, speech and language therapy to stroke patients. The first cognitive linguistics application to achieve this status by FDA, ST App’s Breakthrough Device designation is also the first for The Learning Corp, which combines AI and real-world evidence to deliver next-generation brain health products and research. ST App is designed as an accessible, home-based therapy solution for patients that also allows clinicians to check in remotely on progress.

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Jun 01,2020

Blue Note Therapeutics Receives Breakthrough Device Designation from FDA for Prescription Digital Therapeutic to Treat Cancer-Related Anxiety and Depression

Blue Note Therapeutics, Inc., a prescription digital therapeutics company, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to BNT001, the company’s lead prescription digital therapeutic (PDT) candidate for the treatment of symptoms of anxiety and depression related to cancer in adult patients.

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Jun 03,2020

BlueStar's eighth FDA clearance adds long-acting basal insulin support for Type 2 patients

WellDoc's BlueStar chronic disease-management tool has picked up another 510(k) FDA clearance that will allow it to support adult Type 2 diabetes patients using long-acting basal insulin. The feature was announced by WellDoc this morning, but cleared by the agency in April, according to a listing on its website. The new capability takes the form of a new program within the prescription BlueStar app, called the Insulin Adjustment Program. Healthcare providers use a web-based interface to prescribe an initial dose of long-acting basal insulin, which the new feature then uses to guide patients with subsequent titrations.

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