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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Apr 25,2024

Lupin Digital Health’s platform receives Class C medical device license from CDSCO

Lupin Digital Health's Lyfe platform has obtained approval as a Class C Medical Device from the Central Drugs Standard Control Organization (CDSCO), marking India’s first clinically proven remote cardiac rehabilitation program. Lyfe aims to enhance heart health and quality of life. Rajeev Sibal, President-India Region Formulations at Lupin, highlights the company's dedication to cardiac care excellence. Sidharth Srinivasan, CEO of Lupin Digital Health, underscores the significance of this license, emphasizing Lyfe's potential to support millions of cardiac patients and improve health outcomes.

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Apr 12,2024

h2o Therapeutics' Apple Watch feature for Parkinson's gets FDA medical device listing

h2o therapeutics, a digital health startup based in Turkey, has announced the FDA listing of its Apple Watch-enabled freezing of gait-cuing feature, Foggy, as a Class II medical device for Parkinson’s Disease patients. Foggy utilizes the Apple Watch's Taptic Engine to provide vibrotactile stimulation when a patient experiences freezing of gait, assisting with movement. The feature is accessible through the Parky app by prescription. This advancement aims to enhance accessibility and ease of use for cueing strategies in Parkinson's treatment.

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Apr 23,2024

Curio Digital Therapeutics Inc. Announces the FDA Clearance of MamaLift Plus

Curio Digital Therapeutics announces the FDA clearance of MamaLift Plus, marking the first prescription digital therapeutic for postpartum depression (PPD). MamaLift Plus is an eight-week prescription digital therapeutic intended for patients 22 years and older, to be used under healthcare provider supervision. It offers neurobehavioral interventions including Cognitive Behavioral Therapy (CBT), Behavioral Activation Therapy (BAT), Interpersonal Therapy (IPT), and Dialectical Behavior Therapy (DBT). Clearance is based on the SuMMER study, a national, sham-controlled, pivotal randomized controlled trial (RCT), where MamaLift Plus demonstrated efficacy in improving symptoms of depression. The study achieved its primary endpoint with 86.3% of participants experiencing a clinically meaningful improvement.

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Apr 30,2024

Eversense® CGM System Receives iCGM Designation by the US FDA

Senseonics Holdings and Ascensia Diabetes Care announced that the Eversense continuous glucose monitoring (CGM) system has received integrated CGM (iCGM) designation from the US FDA. This marks the first fully implantable device in this category, authorized for marketing through the FDA's De Novo pathway. The iCGM status allows Eversense to integrate with compatible medical devices, such as insulin pumps, particularly for automated insulin delivery (AID) systems. The companies intend to pursue partnerships with various pump manufacturers to offer users of diabetes devices a new interoperable CGM option suitable for AID systems.

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Apr 19,2024

Korea approves 2 more DTx for vision improvement, respiratory rehabilitation

The Ministry of Food and Drug Safety in South Korea has granted approval to two new digital therapeutic (DTx) devices, developed by Nunaps and Share&Service. Nunaps VIVID Brain is a mobile application tailored for patients with vision impairments due to brain disorders, offering a 12-week visuoperceptual training program to expand the visual field. Share & Service's EasyBreath, on the other hand, is an eight-week customized respiratory rehabilitation program for individuals with COPD, asthma, and lung cancer, focusing on enhancing aerobic capacity and reducing breathlessness. These approvals mark the third and fourth authorized DTx devices in South Korea, signifying a growing recognition of software-based interventions to prevent, manage, or treat medical impairments or diseases.

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Mar 31,2024 TOP STORY

Otsuka and Click Therapeutics Announce the FDA Clearance of Rejoyn for the Adjunctive Treatment of Major Depressive Disorder Symptoms

Otsuka Pharmaceutical and Click Therapeutics announce that the U.S. FDA has cleared Rejoyn™ (developed as CT-152), the first prescription digital therapeutic authorized for the treatment of major depressive disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD age 22 years and older who are on antidepressant medication. Rejoyn is intended to reduce MDD symptoms, and it is a six-week treatment program designed to help enhance cognitive control of emotion through a combination of clinically-validated cognitive emotional training exercises for the brain and brief therapeutic lessons. The clearance of Rejoyn is based on data from the Mirai study, a 13-week pivotal, multicenter, remote, double-blinded, randomized, controlled trial of 386 participants, aged 22 to 64, diagnosed with MDD who were on antidepressant medication for the treatment of depression. In the trial, individuals treated with Rejoyn showed an improvement in depression symptom severity from baseline. Following the FDA's approval, it is expected to be available for download from app stores in the latter half of 2024, upon healthcare professionals' prescriptions for their patients.

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