Jan 04,2023

Medisafe Expands Business Solutions with New Software as a Medical Device (SaMD)

As the number of software for the management of disease continues to grow, Medisafe's progression represents both the company's commitment to adhering to regulatory standards and exceeding industry expectations, as well as its leadership in the growth of SaMD. This announcement comes just months after achieving ISO 13485:2016 certification, meeting quality management system parameters specific to medical devices, as well as ISO 27001:2013 certification, meeting IT security management system standards specific to medication and digital health platforms.

PRODUCT

#software

#mobile app

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Jan 05,2023

Pivotal Trial of EndeavorRx® in Adolescents with ADHD Shows Robust Improvements in Attention and Broader Clinical Outcomes

Akili, Inc. today announced topline results of the STARS-ADHD-Adolescents label expansion study evaluating the efficacy and safety of EndeavorRxⓇ (AKL-T01) in adolescents ages 13-17 with attention-deficit/hyperactivity disorder (ADHD). The pivotal study achieved its predefined primary efficacy outcome, showing statistically significant improvement in attentional functioning after four weeks of treatment. Consistent improvements were also seen in a range of secondary measures of ADHD-related inattention symptoms and functioning.

CLINICAL STUDY

#pdt

#software

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Jan 05,2023

Mental Health App Woebot Passes ORCHA’s Rigorous New Digital Health Assessment Framework

Woebot, a mental health app from Woebot Health, has passed the rigorous new Digital Health Assessment Framework (DHAF) that aims to enhance health application standards in the United States. The open framework includes components to assess privacy and security, clinical assurance and safety, and usability, and was crafted to support U.S.-specific guidelines, regulations and best practices for digital health technologies.

PRODUCT

#cbt

#software

#chatbot

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Jan 10,2023

Hygieia Expands to Arizona, as Endocrinology Associates, PA, Joins d-Nav® Insulin Management Clinical Partnership Program

Hygieia, a provider of digital therapeutics for insulin management, has added Endocrinology Associates, PA, in Scottsdale and Chandler, AZ, as a clinical partner. This makes Hygieia’s d-Nav® autonomous insulin therapy service available to patients with type 2 diabetes in Arizona. Partnership model gives physicians better tools for insulin therapy and offers new reimbursement opportunities

COLLABORATION PARTNERSHIP

#institution

#software

#reimbursement

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Jan 17,2023

MedRhythms Announces Positive Topline Results from Pivotal Trial in Chronic Stroke

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. The trial included adult chronic stroke survivors who participated in thirty-minute sessions three times per week over a five-week intervention period. The study participants either used MR-001 or were part of an active control group. MedRhythms intends to submit this important clinical data for peer review in a scientific journal and to present the data at a major conference later this year.

PRODUCT

#software

#connected device

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Jan 23,2023

Woebot Health Enrolls First Patient in Pivotal Clinical Trial of WB001 for Postpartum Depression

Woebot Health today announced the enrollment of the first patient in a pivotal clinical trial to evaluate the safety and efficacy of WB001, an investigational digital therapeutic for postpartum depression (PPD) that was granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) in 2021. The multi-center, double-blind, randomized controlled study is actively recruiting women ages 22 to 45 who have given birth in the last three months and are experiencing mild to moderate PPD.

PRODUCT

#cbt

#software

#chatbot

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Jan 24,2023

Curebase Launches All-in-One Software and Trial Execution Package to Help Digital Therapeutics Companies Accelerate Clinical Trials

Curebase, a company committed to democratizing access to clinical trials, announced the release of its integrated software and services package for digital therapeutics (DTx) trials that accelerates enrollment and allows sponsors to launch their studies faster. The new Curebase digital therapeutics offering includes features, workflows, and tools built into the company's eClinical platform specifically made for and used in DTx studies. This also includes virtual site models, CRO services, and recruitment tactics tried and tested in digital therapeutic studies, allowing DTx sponsors to quickly launch a study with the confidence of proven execution.

PRODUCT

#software

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Jan 31,2023

MedRhythms' Feasibility Study Shows Positive Topline Results in Parkinson's Disease

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). The MR-005 feasibility study results revealed enhanced quality of life and high patient adherence rates, which were the primary endpoints for this study. Additionally, preliminary results showed improvement in motor symptoms of PD, walking capacity and functional mobility. The results of this study will be submitted for a peer-reviewed publication and also presented at the upcoming American Physical Therapy Association Combined Sections Meeting.

CLINICAL STUDY

#software

#connected device

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Feb 02,2023

Beacon Health System to Leverage Biofourmis Solution for Post-Discharge Remote Patient Monitoring Program to Reduce Readmissions and Optimize Outcomes Across Complex Chronic Conditions

Biofourmis announced today an agreement with Beacon Health System in South Bend, Ind., for a multi-hospital post-discharge remote patient monitoring (RPM) program for complex chronic conditions to reduce readmissions, expand care access across the region, and improve clinical outcomes. Beacon is launching its post-discharge RPM program with Biofourmis across two of its largest hospitals—Elkhart General Hospital and Memorial Hospital. Patients with congestive heart failure or chronic obstructive pulmonary disease (COPD) who meet certain criteria are to be enrolled in the program in the first year.

PRODUCT

#rpm

#software

#connected device

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Dec 20,2022

Bill could pave the way for prescription digital therapeutics reimbursement

New legislation would allow for reimbursement of prescribed digital therapeutics under Medicare, which proponents argue could increase access to these emerging treatments. Still, others say it's new technology, and the wrong reimbursement model could tamper innovation and increase patient costs. The Access to Prescription Digital Therapeutics Act of 2022, introduced in the U.S. Senate in March, aims to amend the Social Security Act to provide Medicare coverage and reimbursement for prescription digital therapeutics.

#reimbursement

#software

#pdt

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