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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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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Mar 19,2024 TOP STORY

Almee Receives Breakthrough Device Designation From the FDA

Alex Therapeutics and Vicore Pharma announced FDA Breakthrough Device Designation status for Almee, a 9-week digital cognitive behavioral therapy (CBT) delivered in a patient-facing tool, to be used as an adjunct treatment of anxiety symptoms related to Pulmonary Fibrosis. Almee has shown effectiveness in reducing anxiety symptoms and improving health-related quality of life in the COMPANION study as reported earlier this year, driving a 2.7-point increase in GAD-7 (generalized anxiety disorder scale) score and a 4.4 improvement in KBILD (King’s Brief Interstitial Lung Disease) score. As next steps, Vicore is seeking to advance Almee in partnership with the developers of approved and late-stage molecular therapies for the treatment of pulmonary fibrosis.

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Mar 18,2024 TOP STORY

Sequel’s twiist™ Automated Insulin Delivery System Receives FDA 510(k) Clearance

Sequel Med Tech, a company developing insulin delivery technologies, announced its partner, DEKA Research & Development Corp., has received 510(k) clearance from the U.S. FDA for the twiist Automated Insulin Delivery (AID) system powered by Tidepool. The twiist AID system, which will be commercialized by Sequel Med Tech, LLC, is the first drug delivery system that directly measures the volume and flow of insulin delivered with every micro-dose. Cleared for people ages 6 and up with type 1 diabetes, the twiist AID system offers the capability to address each patient’s individual dosing needs. The twiist system incorporates FDA-cleared Tidepool Loop technology, which enables the system to automatically adjust insulin delivery based on CGM readings and predicted glucose levels.

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Mar 08,2024 TOP STORY

Dexcom over-the-counter Stelo Glucose Biosensor wins FDA clearance

Dexcom has received FDA clearance for its over-the-counter continuous glucose monitoring (CGM) solution called Stelo, which offers round-the-clock glucose readings directly to smartphones. The wearable biosensor has a two-week battery life and detects normal as well as low or high glucose levels. It's tailored for adults managing diabetes with oral medications or needing insight into lifestyle impacts on blood sugar levels. While not indicated for problematic hypoglycemia, it aims to empower users with actionable insights. Stelo is set for online release in summer 2024.

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Jan 30,2024

NuvoAir’s Air Next Spirometer is FDA-approved for in-home use

NuvoAir Medical announced its innovative Air Next Spirometer has received formal 510(k) clearance for in-home use as a full spirometer. 510(k) clearance allows Air Next to conduct full spirometry at home, providing extremely valuable clinical data that ensures patients can be monitored continuously. High-quality lung data empowers the NuvoAir clinical team to intervene when changes are detected and provide instantaneous care before lung function deteriorates to the point where hospitalizations are necessary. By achieving 510(k) clearance, the Air Next Spirometer can now be used for ATS 2019-compliant spirometry in clinical trials across the US and Europe.

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Feb 20,2024 TOP STORY

Better Therapeutics Receives FDA Breakthrough Device Designation for Digital Therapeutic Platform Targeting Advanced Liver Disease

Better Therapeutics announced that the U.S. FDA has granted Breakthrough Device Designation for its novel Cognitive Behavioral Therapy (CBT) platform intended to treat adults with metabolic dysfunction-associated steatohepatitis (MASH), formerly known as NASH. Better Therapeutics earned breakthrough status based on the outcomes of its LivVita clinical study, which successfully met its primary endpoint by reducing liver fat within 90 days, while also achieving key secondary endpoints related to improved liver health without any device-related adverse events. Results of the study were published in Gastro Hep Advances. Better Therapeutics’ novel form of CBT works by targeting the lifestyle behaviors that are known to cause and/or contribute to the progression of metabolic diseases. The Company’s CBT platform has already demonstrated clinically meaningful outcomes in type 2 diabetes (T2D), leading to the FDA authorization of AspyreRx™ in 2023 as the first prescription digital therapy to deliver CBT as a treatment for T2D.

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Feb 20,2024

Better Therapeutics Receives FDA Breakthrough Device Designation for Digital Therapeutic Platform Targeting Advanced Liver Disease

Better Therapeutics announced that the FDA has granted Breakthrough Device Designation for its novel Cognitive Behavioral Therapy (CBT) platform intended to treat adults with metabolic dysfunction-associated steatohepatitis (MASH), formerly known as NASH. Better Therapeutics earned breakthrough status based on the outcomes of its LivVita clinical study, which successfully met its primary endpoint by reducing liver fat within 90 days, while also achieving key secondary endpoints related to improved liver health without any device-related adverse events. Results of the study were published in Gastro Hep Advances. Besides this, the Company’s CBT platform has already demonstrated clinically meaningful outcomes in type 2 diabetes, leading to the FDA authorization of AspyreRx™ in 2023 as the first prescription digital therapy to deliver CBT as a treatment for T2D.

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