Sep 09,2024

Highmark expands coverage for RelieVRx device for 4M+ members

Pittsburgh-based Highmark has signed on as AppliedVR's first commercial payer partner, making its flagship VR device for chronic lower back pain a covered treatment for more than 4 million plan members. The program consists of a headset and software guiding patients in pain management exercises. It represents a novel home-based solution for treating chronic pain. The company says RelieVRx serves as a cost-effective, non-pharmacologic adjunctive therapy clinically proven to significantly reduce pain intensity and interference across sociodemographic groups. Highmark’s decision to cover RelieVRx follows a thorough evaluation of AppliedVR’s extensive clinical studies, including a large study with more than 1,000 participants that found RelieVRx can have a clinically meaningful impact on reducing pain intensity and interference. Eligible commercial members aged 18 and older diagnosed with moderate to severe chronic lower back pain can now obtain a prescription for RelieVRx from their healthcare provider without prior authorization. The company says it now works with 200 leading health systems and thousands of healthcare professionals globally, used on more than 60,000 patients.

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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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Jun 18,2024

Real-World Data Reinforces Efficacy of Luminopia in Improving Vision for Patients with Amblyopia

Luminopia Inc. announced that real-world data from the Patients Using Prescription Luminopia (PUPiL) Registry™ continues to show the efficacy of its FDA-approved therapy for improving vision in children with amblyopia. The therapy combines therapeutic software with virtual reality (VR) headsets and popular children's TV shows. Data presented at the European and International Strabismological Association conference confirmed significant visual acuity improvements after 12 weeks of treatment, aligning with clinical trial results. The treatment, which avoids the compliance issues associated with traditional methods like eye patching and atropine drops, demonstrated high adherence and no safety events. This digital therapeutic uses dual-acting algorithms to encourage the brain to use both eyes together, providing a unique and effective alternative to conventional treatments.

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Dec 07,2022

MINDMAZE AND VIBRA HEALTHCARE PARTNER TO DELIVER ADVANCED DIGITAL MEDICINE AND NEUROREHABILITATION SOLUTIONS FOR PATIENTS FROM CLINIC-TO-HOME

MindMaze and Vibra Healthcare are partnering to deploy MindMaze's digital health technology platform, including MindPod® and MindMotion®GO, in select Vibra hospitals in Kentucky and California. The platform aims to help patients regain function through digitally-enabled assessments and behavioral training for various neurological conditions like Stroke, TBI, Parkinson's Disease, and more. This collaboration will enable clinicians to deliver interventions with higher dosage and intensity levels, enhancing patient care across different healthcare settings.

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May 29,2024 TOP STORY

Virtual Therapeutics, Akili Interactive Enter Into Definitive Merger Agreement

Virtual Therapeutics and Akili Interactive have signed a definitive merger agreement to create a leading digital health company. Under the agreement, Akili shareholders will receive $0.4340 per share in cash, representing a 4% premium to Akili’s closing stock price on May 28, 2024, and an 85% premium to its price on April 29, 2024. Post-merger, the combined entity will operate as Virtual Therapeutics, with Akili as a wholly owned subsidiary. The merger aims to leverage Virtual Therapeutics' VR-based mental health solutions and Akili's mobile digital therapeutics expertise to address global mental health challenges. The transaction, approved by both companies' boards, is expected to close in the third quarter of 2024, subject to certain conditions. After completion, Akili's stock will be delisted from public exchanges.

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Mar 18,2024

Autism Tech Startups Aim for FDA Approval, Driving Efficiency, Market Growth

The article discusses the growing trend of startups seeking FDA clearance for autism spectrum disorder (ASD) interventions, moving beyond traditional behavior therapies. These companies aim to bring scientific rigor and scrutiny to their approaches, similar to medical devices, to address challenges like subjective diagnosis and lengthy treatment processes. Case studies include companies like JelikaLite using transcranial photobiomodulation, EarliTec Diagnostics with eye-tracking diagnostic technology, and Cognoa offering a digital autism diagnosis.

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Feb 27,2024

Mynd Immersive Launches XR Therapy program for Native American Seniors

Mynd Immersive (fka. MyndVR) has announced its partnership with Cherokee Elder Care (CEC) in Tahlequah, Oklahoma. CEC is a non-profit entity of the Cherokee Nation, providing a long-term care option for anyone that meets the qualifications. Individuals do not have to be Native American to qualify. This marks the first time the CEC has implemented any form of VR therapy for its seniors. 

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Feb 12,2024

Curavit Successfully Completes a Virtual Clinical Trial for Sana's Investigative Digital Therapeutic to Treat Symptoms of PTSD

Curavit Clinical Research, a virtual contract research organization (VCRO) that specializes in decentralized clinical trials (DCTs) for digital therapeutics (DTx), has announced the successful completion of a decentralized trial for the Sana Health's device. Sana has submitted the trial data for Breakthrough Device Designation consideration from the U.S. Food and Drug Administration (FDA) for its wearable, virtual-reality-style mask that uses audiovisual stimulation to reduce symptoms of post-traumatic stress disorder (PTSD). More than 45 patients were recruited from a Veteran's hospital participated in the 28-day study. The trial was carried out with a grant from CDMRP funds, disbursed through the Military Operational Medicine Research Program (part of the DoD). It was designed to gather evidence on the Device's ability to allow patients suffering from PTSD to gain additional relief whilst on waiting lists for further specialty care. Previously, the Sana Device received FDA Breakthrough Device Designation for treatment of Fibromyalgia in 2021.

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Feb 08,2024

AppliedVR and Kernel Flow Announce Clinical Results Evaluating How Brain Changes During Virtual Reality Treatment of Chronic Pain

AppliedVR and Kernel announced a joint study measuring the impact of VR pain treatment on the brain. The study, which included a single-blind, sham-controlled design, compared brain activation patterns and physiological metrics before, during, and after VR experiences in people experiencing chronic low back pain (CLBP). The research used AppliedVR's RelieVRx medical device, an eight-week, skills-based program that helps chronic low back pain patients learn self-management skills, combined with Kernel Flow and FlowVR—a TD-fNIRS brain measurement headset customized for use in VR—to measure brain hemodynamic changes associated with pain relief. While participants in the RelieVRx and sham groups both experienced varying levels of pain relief after completing the eight-week treatment, researchers determined that participants in the RelieVRx group experienced enhanced brain activation coherence -- change that previously has been related to reduced pain -- from pre-to-post treatment. Those patients receiving the VR sham control demonstrated a decline in brain coherence. Additionally, those receiving treatment from the RelieVRx device achieved a slower breathing rate as compared to the sham VR group. These results suggest that active RelieVRx treatment can create physiological changes in the body and have an impact on coherent global brain activity.

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Feb 06,2024

U.S. Department of Veterans Affairs Taps Mynd Immersive to Create Landmark VR Application for Vietnam Veterans

In a significant development, Mynd Immersive, a leading provider of XR-based, digital therapeutics, announced today that it had signed a 3-year Cooperative Research and Development Agreement with the U.S. Department of Veterans Affairs (VA) to develop "Virtual Vietnam: A Path to Peace," a landmark virtual reality (VR) project for aging Vietnam Veterans. Mynd Immersive is now deployed in nearly 100 long-term Veteran care facilities across the United States. In a large, multi-year study with Stanford, Mynd has been shown to improve mood, reduce feelings of isolation and improve the relationship between older adults and their caregivers. This new collaboration will enlist the input of Veterans across the nation. Their firsthand experiences and perspectives will guide virtual journeys that are respectful, therapeutic, and empowering.

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