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After the FDA released draft guidance on increasing diversity in clinical trials, companies have been left to figure out the details. Here’s what experts say is working.
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MedRhythms Announces FDA Listing of InTandem™ (MR-001) to Improve Walking and Ambulation in Adults with Chronic Stroke
7/6/2023
MedRhythms today announced that MR-001, the company's evidence-based neurorehabilitation system to improve walking and ambulation in adults with chronic stroke walking deficits, has been listed as a Class II medical device with the U.S. Food and Drug Administration (FDA).
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MedRhythms' Feasibility Study Shows Positive Topline Results in Parkinson's Disease
1/31/2023
MedRhythms announced the successful completion of a multi-site feasibility study of MR-005, its investigational asset in development for the treatment of gait deficits in Parkinson's disease (PD).
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MedRhythms Announces Positive Topline Results from Pivotal Trial in Chronic Stroke
1/17/2023
MedRhythms announced today that the company's pivotal trial for MR-001, a novel digital intervention in development to treat gait deficits in chronic stroke, was successfully completed and met its primary endpoint.
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Biogen and others are seeing the value in, particularly, non-prescription digital therapeutics, as complementary companion therapies to disease-modifying drugs.
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Biogen is bolstering its multiple sclerosis (MS) pipeline through a licensing agreement with Maine-based MedRhythms for its investigational digital therapeutic, MR-004.
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Biogen and MedRhythms to Develop and Commercialize a Prescription Digital Therapeutic Targeting the Treatment of Gait Deficits in Multiple Sclerosis
5/5/2022
Biogen Inc. and MedRhythms have entered into a license agreement to develop and commercialize MR-004, an investigational prescription digital therapeutic for the potential treatment of gait deficits in multiple sclerosis.
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Digital Therapeutics Alliance Appoints MedRhythms Co-Founder Owen McCarthy to Chair Board of Directors
1/18/2022
Digital Therapeutics Alliance (“DTA” or “Alliance”), today announced the appointment of Owen McCarthy, Co-Founder & President, MedRhythms, to Chair its Board of Directors.
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Castor Leads Next-Gen Clinical Trials that Support Digital Therapeutics
8/18/2021
Castor announced that it is powering the next generation of clinical trials with more than 30 digital therapeutics (DTx) studies ongoing.
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MedRhythms Initiates Clinical Trial and Expands Pipeline into Acute Stroke
4/28/2021
MedRhythms, a digital therapeutics company building direct stimulation solutions that use clinical-grade sensors, software and music to help restore function lost to neurologic disease or injury, today announced the launch of a clinical trial that will study MR-010, MedRhythms' acute stroke asset.
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MedRhythms, Roux Institute Partner in the Fields of Neuroscience, Artificial Intelligence
11/17/2020
MedRhythms, a digital therapeutics company building direct stimulation solutions that use clinical-grade sensors, AI-driven software and music to help restore function lost to neurologic disease or injury, today announced a partnership with the Roux Institute
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MedRhythms Receives FDA Breakthrough Device Designation for Chronic Stroke Digital Therapeutic
6/15/2020
MedRhythms announced that it has received Breakthrough Device designation from the U.S. Food and Drug Administration for its patented digital therapeutic to treat chronic stroke walking deficits.
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MedRhythms Announces an Expansion of Intellectual Property Portfolio, Securing Patent on Audio Engine for Digital Therapeutics Platform
4/17/2020
MedRhythms, a Portland, Maine-based company building direct stimulation digital therapeutics that use sensors, software, and music to measure and improve walking, announced today the issuance of patent US20190022351A1 by the United States Patent and Trademark Office (USPTO).
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MedRhythms CEO Speaking at American Physical Therapy Association Combined Sections Meeting; Feasibility Study Results to be Presented
2/12/2020
MedRhythms, announced today that its CEO, Brian Harris, will be speaking in Denver, Colorado at the 2020 Combined Sections Meeting (CSM) that is held by the American Physical Therapy Association (APTA).
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MedRhythms Announces Issuance of US Patent Covering Their Innovative Digital Therapeutic Platform
12/2/2019
MedRhythms, a Portland, Maine-based digital therapeutics company, today announced the issuance of US patent US20170296116A1, "Systems and Methods for Neurologic Rehabilitation.
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MedRhythms Initiates Multi-Site Randomized Controlled Trial at the Nation’s Top Rehab Hospitals for Its Post-Stroke Walking Rehabilitation Device
10/28/2019
MedRhythms, Inc., a Portland, Maine-based digital therapeutics company, today announced the launch of its 5-site randomized controlled trial (RCT) at the nation’s top rehabilitation hospitals and research centers to study a device that is the first product in the Company’s pipeline of digital therapeutics for neurologic disease and injury.
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AMCP Partnership Forum on Digital Therapeutics Lays Groundwork for Coverage Decisions
9/26/2019
AMCP last week gathered a group of diverse health care stakeholders to discuss the challenges and opportunities of ensuring patient access to a category of emerging therapies known as "digital therapeutics," which have the potential to treat a wide range of diseases and medical conditions.
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MedRhythms Adds Stroke Scientific Advisory Board
7/9/2019
MedRhythms, a Portland, Maine-based digital therapeutics company, announced the addition of a Stroke Scientific Advisory Board.
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Leading Digital Analytics And Digital Therapeutics Companies Mix Music And Data To Help Survivors Of Stroke
6/11/2019
Health Catalyst, Inc. and MedRhythms, Inc. are teaming up to help the millions of Americans who are survivors of stroke to access a promising new digital therapeutic that uses sensors, music and artificial intelligence to measure and improve walking