Oct 02,2019

Biofourmis Named to the 2019 CB Insights Digital Health 150 List of Most Innovative Digital Health Startups

CB Insights announced today at its Future of Health conference that Biofourmis, a Boston-based fast-growing global leader in digital medicine, has been named to the organization’s inaugural Digital Health 150 ranking, which showcases the 150 most promising private digital health companies in the world.

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Oct 04,2019

Biofourmis Analytics Engine Receives FDA Clearance for Ambulatory Physiologic Monitoring

Boston-based Biofourmis has received 510(K) clearance for its machine-learning and artificial intelligence (AI)-powered analytics engine as a medical device for ambulatory physiological monitoring. This regulatory approval is part of the FDA’s growing recognition of machine-learning and AI in the Software as a Medical Device category.

REGULATORY FDA

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Oct 22,2019

DarioHealth Appoints Digital Therapeutics Pioneer Dr. Abigail Hirsch to Its Advisory Board to Support Commercial Strategy and Execution

DarioHealth Corp. (NASDAQ: DRIO) ("DarioHealth" or "Dario"), a leading, global digital therapeutics company, has appointed Dr. Abigail Hirsch to its Advisory Board where she will help guide commercial and Business-to-Business (B2B) efforts.

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Oct 28,2019

MedRhythms Initiates Multi-Site Randomized Controlled Trial at the Nation’s Top Rehab Hospitals for Its Post-Stroke Walking Rehabilitation Device

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. This RCT will examine the product’s impact on walking among a group of subjects who are stroke survivors with post-stroke walking impairments.

PRODUCT

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Mar 19,2019

One Drop Partners With Amazon's Choice To Expand Health Services Offering

One Drop, a leader in the development of digital therapeutics solutions for people with diabetes and related conditions, today announced a partnership with Amazon's exclusive health brand, Choice. Through this partnership, One Drop and Amazon's Choice will bring affordable, accessible, and comprehensive digital health management services to Amazon's Choice customers living with diabetes and hypertension nationwide.

COLLABORATION PARTNERSHIP

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Apr 04,2019

Pear Therapeutics director outlines challenges of regulated software design

Figuring out the best user experience can be a tricky process for any platform. But its particularly important in digital therapeutics, which some view as a disruptor to traditional pharmaceuticals. Unlike medical drug makers, digital therapeutics companies have UX design to consider during the development of their products, Madhavi Jagdish, director of product designer at Pear Therapeutics, said at Mad*Pow's HXD 2019 in Boston.

PRODUCT

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#cbt

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Apr 10,2019

Cognoa Licenses Innovative Digital Therapeutic Technology

Cognoa, a company at the forefront of digital behavioral health for children, today announces it has exclusively licensed technology from the Stanford University School of Medicine to accelerate development and worldwide commercialization of a novel digital therapeutic for children with autism spectrum disorder (ASD). Cognoa’s ASD digital therapeutic uses the licensed technology to target the core deficit of social-emotional reciprocity in autism.

PRODUCT

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#software

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Apr 22,2019

Susmed: Demonstration of Clinical Data Managing System Using Blockchain Technology

Susmed is a Japanese leading digital therapeutics startup and is focusing on the research and development of smartphone applications as software medical devices for treatment of diseases such as insomnia. Company today announced that “Regulatory Sandbox System”, pilot projects led by Japanese government, on the “Demonstration of Clinical Data Monitoring System Using Blockchain Technology”, has been certified by the Ministry of Health, Labor, and Welfare and the Minister of Economy, Trade and Industry. In this pilot project, the system uses blockchain technology, which is expected to be more cost-effective than conventional methods in monitoring of clinical researches and ensuring data accuracy during monitoring.

PRODUCT

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May 02,2019

FDA clears Biofourmis' software for ECG-based arrhythmia detection

The FDA has granted 510(k) clearance to Biofourmis’ RhythmAnalytics, a cloud-based software product that uses deep learning to read and interpret cardiac arrhythmias. According to a statement from the company and the FDA’s clearance letter, RhythmAnalytics collects single-lead ECG data from a range of FDA-cleared devices, and from these scan for more than 15 types of cardiac arrhythmias, including ventricular arrhythmia, ventricular ectopic beats and non-paced arrhythmias, such as atrial fibrillation.

REGULATORY FDA

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Aug 02,2019

Progentec Diagnostics Merges with Karate Health to Expand Autoimmune Disease Management Platforms

Progentec Diagnostics, Inc. and Karate Health, Inc. announced that they have merged, offering laboratory testing and digital technologies for the diagnosis and management of lupus (SLE), multiple sclerosis (MS), and other autoimmune diseases. Progentec’s experienced team of clinical researchers and laboratory operations experts will be joined by Arif Sorathia and Brett Adelman, the co-founders of Karate Health. Sorathia and Adelman will lead digital initiatives including the exploration and development of digital therapeutics, the expansion of direct-to-patient toolkits, and the refinement of 21 CFR Part 11 compliant data-capture tools.

COLLABORATION MERGERS & ACQUISITION

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