Aug 08,2024 TOP STORY

Big Health receives FDA clearance for DTx for insomnia

Big Health has received FDA clearance for SleepioRx, a digital therapeutic designed to treat chronic insomnia and insomnia disorder in adults over 18. Based on its existing product, Sleepio, SleepioRx delivers self-directed cognitive behavioral therapy over 90 days, depending on the severity of the condition. This FDA approval enables healthcare providers to prescribe SleepioRx as an alternative to medication or therapy, which often involves long waiting times. The product’s effectiveness has been demonstrated in clinical trials, with up to 76% of users achieving long-term sleep improvements.The FDA clearance comes as Medicare is considering covering FDA-approved digital mental health treatments in 2025, which could expand access to SleepioRx.

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Aug 08,2024 TOP STORY

U.S. Food and Drug Administration Grants Clearance for Big Health's SleepioRx

Big Health, a developer of digital mental health treatments, received FDA clearance for its flagship digital therapeutic, SleepioRx, designed to treat chronic insomnia in adults. SleepioRx, which delivers Cognitive Behavioral Therapy for Insomnia (CBT-I), can now be prescribed by licensed healthcare providers. The 90-day treatment has been proven effective in reducing sleep issues, with benefits lasting up to three years. With the proposed 2025 Medicare rule to reimburse FDA-cleared digital treatments, SleepioRx could see broader adoption.

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Jun 07,2024

India-made gastric cancer detection device gets 'breakthrough' status

Indian medical diagnostics company RNT Health Insights has received a Breakthrough Device designation from the United States Food and Drug Administration for its early gastric cancer detection tool. Its device is used during endoscopic procedures to detect lesions indicative of gastric cancer in the upper GI tract. It can also spot gastric atrophy, nodules, polyps, masses and growths in the stomach. RNT Health claims from preclinical validation that its device has 96% detection accuracy. 

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Aug 07,2024

Medtronic announces FDA approval of Simplera CGM

Medtronic announced FDA approval for its Simplera continuous glucose monitor (CGM), its first disposable, all-in-one CGM that's half the size of previous models, designed for easier insertion and wear without overtape. The Simplera™ platform includes the Simplera CGM and the Simplera Sync™ sensor, which integrates with Medtronic's MiniMed 780G system and will eventually work with the InPen™ smart insulin pen.

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Jun 20,2024

mylife Loop reaches important milestone toward US approval

CamAPS FX algorithm, developed by CamDiab and partnered with Ypsomed, has received market authorization from the FDA in the United States. This milestone marks a significant step towards introducing the mylife Loop, an automated insulin delivery (AID) solution, to the US market. The mylife YpsoPump, which is part of the mylife Loop system, is currently under FDA review as an interoperable insulin pump. Sébastien Delarive, Chief Business Officer of Ypsomed Diabetes Care, highlights the importance of this approval for people with type 1 diabetes in the US, noting that mylife Loop has already demonstrated high customer satisfaction and penetration in Europe. Overall, mylife Loop combines the CamAPS FX algorithm with the mylife YpsoPump and options for continuous glucose monitoring systems from Abbott or Dexcom, providing an advanced hybrid closed-loop system for managing type 1 diabetes.

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Jun 18,2024

CeQur Simplicity™, a Wearable Mealtime Insulin Delivery Device, Obtains FDA-Clearance for 4 Days of Wear to Further Simplify Diabetes Management

CeQur has received FDA clearance for its CeQur Simplicity™ wearable insulin delivery device to extend wear duration from 3 to 4 days. This advancement aims to simplify diabetes management by reducing the number of injections needed for mealtime insulin. The device is designed to replace up to 12 injections per patch, offering discretion and convenience. Supported by data showing low adherence to A1C goals among people with Type 2 Diabetes using multiple daily injections, CeQur Simplicity's extended wear time intends to enhance dosing adherence and improve quality of life.

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Jun 18,2024 TOP STORY

Akili Announces FDA Authorization of EndeavorOTC, the First FDA Clearance of a Digital Treatment for Adults with ADHD Through a Video Game

Akili, Inc. announced that its digital therapeutic, EndeavorOTC, has received FDA clearance as an over-the-counter treatment for adults with ADHD. This therapy, delivered through an engaging video game, is designed to improve attention function and is now available on iOS and Android. EndeavorOTC is the second FDA-authorized ADHD product by Akili and the only one available without a prescription. The FDA clearance was based on a study involving 221 adults, showing significant improvements in focus and quality of life.

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Jun 10,2024

ABBOTT RECEIVES U.S. FDA CLEARANCE FOR TWO NEW OVER-THE-COUNTER CONTINUOUS GLUCOSE MONITORING SYSTEMS

Abbott has received FDA clearance for two new over-the-counter continuous glucose monitoring (CGM) systems: Lingo and Libre Rio. Lingo is designed for consumers seeking to improve overall health and wellness, providing personalized insights and coaching based on continuous glucose data. It targets metabolic health improvement by tracking glucose levels and lifestyle factors. Libre Rio, Abbott's first OTC CGM for adults with Type 2 diabetes not using insulin, focuses on managing diabetes through lifestyle modifications. Both systems utilize FreeStyle Libre technology and aim to enhance health outcomes by empowering users with actionable glucose data.

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Jun 03,2024

Abbott receives FDA OK for over-the-counter glucose monitor

Abbott has received FDA approval for its over-the-counter glucose monitor, Lingo, which first launched in the U.K. last year. The device is designed for non-diabetics to track glucose spikes. With this clearance, Abbott joins the market alongside Dexcom, which received similar FDA approval for its CGM, Stelo, in March. Abbott has yet to announce the rollout details for Lingo in the U.S.  Abbott plans to market Lingo under a direct-to-consumer, cash-pay model that doesn’t need a prescription.

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May 24,2024 TOP STORY

FDA approves hybrid closed-loop insulin delivery app from CamDiab

CamDiab announced that its CamAPS FX app, an advanced adaptive closed-loop artificial pancreas for type 1 diabetes management, received FDA authorization as an interoperable automated glycemic controller device (iAGC). The Android app, which integrates with compatible insulin pumps and continuous glucose monitors (CGMs) like the Dexcom G6 and FreeStyle Libre 3, is approved for users aged two and older, including pregnant women. Already holding CE mark approval in Europe and the UK, CamAPS FX is available in multiple countries and continues to expand.

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