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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Jun 27,2024

South Korea approves first local skin cancer detection AI

LifeSemantics, a Korean digital health company, has received regulatory approval from South Korea's Ministry of Food and Drug Safety for its AI-powered skin cancer diagnosis solution, canofyMD SCAI. Developed through the Doctor Answer 2.0 project, the mobile AI technology uses convolutional neural networks to diagnose skin cancer, including melanoma and carcinoma, via smartphone images. The AI, trained on 6,500 images, showed an 80.9% diagnostic accuracy in clinical trials. LifeSemantics plans to launch the app commercially by year-end and seeks regulatory approvals in Australia and New Zealand.

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Apr 30,2024

South Korea OKs DTx for vision loss, respiratory rehab

The South Korean Ministry of Food and Drug Safety (MFDS) has approved two new digital therapeutic devices: EasyBreath and VIVID Brain. EasyBreath, developed by Share & Service, is a mobile app offering an eight-week respiratory rehabilitation program for conditions like COPD, asthma, and lung cancer, aiming to reduce breathlessness and improve aerobic capacity. VIVID Brain, by Nunaps, is a VR-based software providing 12-week visual perception training to enhance brain elasticity and expand the visual field for patients with cognitive impairments. Both devices were fast-tracked as innovative medical devices and are the third and fourth digital therapeutics approved in South Korea, following earlier approvals for insomnia treatments.

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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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Jul 09,2024 TOP STORY

Roche receives CE Mark for its AI-enabled continuous glucose monitoring solution

Roche announced today that it has received the CE Mark for its Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution with 14-day wear time. This significant milestone paves the way for the solution to be made available to people living with type 1 and type 2 diabetes over the age of 18 on flexible insulin therapy. Every five minutes, the Accu-Chek SmartGuide CGM sensor sends glucose values measured in real time to the Accu-Chek SmartGuide app. The Accu-Chek SmartGuide Predict app then utilises those glucose values and other available information to detect glucose patterns and predict future glucose levels. Its integrated AI-enabled predictive algorithms indicate hypoglycaemia risk within the next 30 minutes, continuously forecast how glucose levels will develop within the next two hours, and estimate the risk of nocturnal hypoglycaemia. The Accu-Chek SmartGuide solution seamlessly integrates with the Accu-Chek Care platform, offering healthcare professionals access to comprehensive therapy-relevant data provided by the CGM solution.

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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 26,2024

Boston Scientific's DBS software gains CE as Parkinson's treatments advance

Boston Scientific has received the CE mark for its Vercise Neural Navigator 5 software, part of its Deep Brain Stimulation (DBS) system for treating Parkinson's disease. This milestone highlights the trend towards integrating advanced technology and AI in managing neurological conditions, in line with the FDA's call for innovation in Parkinson's treatments. The neurological devices market, valued at $12.5 billion in 2023, is projected to grow to $20.9 billion by 2033, driven by the demand for advanced diagnostic and monitoring tools. Innovations like Boston Scientific’s software and wearable technologies, such as those utilizing Apple Watch data, are enhancing therapeutic interventions and promoting a comprehensive approach to disease management. This shift towards high-tech solutions marks a significant advancement in personalized and effective neurological care.

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