Mar 04,2021

Voluntis Strengthens Its Global Customer Support Services in Collaboration With Zendesk

Voluntis, a leader in digital therapeutics, today announces the upgrade of its global customer support infrastructure in collaboration with customer service software company Zendesk. Thanks to the new collaboration, Voluntis will leverage Zendesk’s capabilities to integrate and streamline the support services it provides for its pharma partners as part of the commercialization of co-developed digital therapeutics and in full compliance with applicable regulations.

COLLABORATION PARTNERSHIP

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Mar 16,2021

FDA-approved gaming is already here, pointing to its therapeutic potential: EndeavorRX

The game, “EndeavorRX” by Akili Interactive, may point to a potentially growing field of prescription-strength gaming, according to the 2021 Tech Trends Report by the Future Today Institute. Akili Interactive formed in 2011 with the intent to create games for clinical therapy. “EndeavorRX” is an on-the-rails, character-based racing game with bright colors, looking similar to a mascot-driven title like “Crash Bandicoot." But its game mechanics are designed “for target activation of specific neural systems in the brain to treat diseases with associated cognitive dysfunction.”

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Apr 06,2021

DTx company Pear inks slew of deals to integrate more digital biomarkers and a digital pill into platform

The Boston-based DTx company has inked collaboration deals with Empatica and KeyWise. Specifically, Pear's collaboration with Empatica will focus on the use of medical-grade wearables and digital biomarkers. The company is looking to use wearables to evaluate a patient's withdrawal symptoms from opioids, alcohol and other substances.

COLLABORATION PARTNERSHIP

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Apr 13,2021

MedRhythms Launches Clinical Trial of Digital Therapeutic in Parkinson’s Disease and Expands Pipeline to Aging

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 initiation of a multi-site clinical trial, in collaboration with Boston University and one of the world's leading hospitals, of its pipeline asset MR-005 in Parkinson's disease (PD) as well as the expansion of the company's pipeline into aging with the development of its Aging Scientific Advisory Board (SAB). This follows MedRhythms' announcement of the advancement of its pipeline into PD and multiple sclerosis (MS) in 2020 with the initiation of clinical trials and the development of MS and PD SABs.

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May 18,2021

MedRhythms, Massachusetts General Hospital Collaborate on Neuroimaging Study in Multiple Sclerosis

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, in collaboration with Massachusetts General Hospital (MGH), that will study MR-004, MedRhythms' multiple sclerosis (MS) asset. This groundbreaking trial was funded by the National Multiple Sclerosis Society and will be the first neuroimaging study aimed at elucidating the impacts of Rhythmic Auditory Stimulation on MS walking impairments. It expands on the research that is being conducted with MR-004 in a clinical trial with Cleveland Clinic that was announced in 2020.

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May 20,2021

MedRhythms and EVERSANA to launch software-based device for stroke

MedRhythms has entered a collaboration with EVERSANA to launch and market its software-based medical device, MR-001, to treat chronic stroke walking impairments. The US-based digital therapeutics company, MedRhythms, received the US Food and Drug Administration’s breakthrough device designation for MR-001 in June last year.

COLLABORATION PARTNERSHIP

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Jun 01,2021

Blue Note Therapeutics Announces Recruitment for Registrational Clinical Trial Studying Effectiveness of Digital Medical Devices in Cancer Patients

Blue Note Therapeutics has announced recruitment for a registrational clinical trial (RCT) to study the effectiveness of two digital, software only, medical devices (SaMD). Both medical devices are anticipated to have an impact on mental and physical health when used adjunctively with multidisciplinary oncology care regimens. The RCT study population will consist of up to 553 patients living with stage I-III breast cancer or stage I-III non-small cell lung cancer. The study will seek to understand and evaluate the overall study outcomes, including impact on mental and physical health.

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Jun 02,2021

Cognoa Receives FDA Marketing Authorization for First-of-its-kind Autism Diagnosis Aid

Cognoa, a pediatric behavioral health company developing diagnostic and therapeutic solutions for children living with behavioral health conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted the company’s De Novo classification request for its autism diagnosis aid. The AI-based device is the first FDA-authorized diagnosis aid designed to help physicians to diagnose autism in the primary care setting.

REGULATORY FDA

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Jun 18,2021

AmalgamRx's insulin titration algorithm has green light in EU

Looking to the European market, digital therapeutics company Amalgam Rx has scored an E.U. CE Mark for its insulin titration algorithm, called iSage Rx, and its white-label variants. oinciding with this announcement AmalgamRx has inked a commercialization deal with diabetes-focused startup Novo Nordisk to expand its white label version of the iSage Rx app called Dose Check into Europe and Asia.

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Jun 22,2021

Exclusive negotiations regarding a potential acquisition of Voluntis by Aptar to expand in digital therapeutics

Voluntis (Euronext Growth Paris, Ticker: ALVTX – ISIN: FR0004183960), a leader in digital therapeutics, and its main shareholders announced today that they have entered into exclusive negotiations with AptarGroup, Inc. (NYSE: ATR), a global leader in drug delivery, consumer product dispensing and active material science solutions, with respect to a potential acquisition of all outstanding shares of Voluntis by Aptar.

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