Nov 16,2020

Voluntis Receives CE Mark for Oleena, Key Milestone to the Future Commercialization of Its Digital Therapeutics for Oncology

Voluntis, a leader in digital therapeutics, today announced that it has received the CE mark for Oleena. Oleena is Voluntis’ proprietary digital therapeutic that enables patients to self-manage symptoms across a wide range of cancer therapies, and also allows care teams to remotely monitor patients. Oleena is based on Voluntis’ Theraxium platform, and its patented algorithm engine, which also serves as the foundation for digital therapeutics the company co-develops with life science partners.

REGULATORY CE MARK

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Dec 03,2020

Biofourmis Announces National Rollout of the Biovitals® Hospital@Home™ Platform to Help Deliver Hospital-Level Care in the Home Aligned with New CMS Program

Biofourmis, a Boston-based global leader in digital medicine and virtual care that powers personalized predictive care, announces the national rollout of Biovitals® Hospital@HomeTM—an artificial intelligence-based, turnkey technology platform that enables hospitals and health systems to quickly deploy a “hospital at home” program. Biofourmis co-developed Biovitals® Hospital@HomeTM with Brigham and Women’s Hospital, a Harvard teaching hospital, for use in Brigham’s Home Hospital Program. Over the past few years they have worked together to refine and scale the platform for use by healthcare organizations nationwide to fuel programs in which patients are “admitted” to their homes for hospital-level care.

PRODUCT

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Dec 10,2020

Cerner, Banner Health, Xealth Partner to Simplify How Clinicians Prescribe Digital Health

Cerner, today announced it’s building on the recent collaboration with Xealth to offer health systems new centralized digital ordering and monitoring for clients. With the new capabilities, health systems can prescribe digital therapeutics, smartphones, and internet applications to address areas such as chronic disease management, behavioral health, maternity care, and surgery prep. Phoenix-based Banner Health, one of the country’s largest nonprofit hospital systems, is one of the first Cerner clients to use the new capabilities to benefit its clinicians and patients.

COLLABORATION PARTNERSHIP

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Dec 14,2020

Welldoc Submits 510(k) for Bolus and Premixed Insulin Titration Program as Part of BlueStar®

Welldoc®, a trailblazer in digital health that is revolutionizing chronic disease management to help transform lives, today announced the filing of its ninth 510(k) with the U.S. Food and Drug Administration (FDA) for BlueStar, an FDA-cleared digital health solution for diabetes. With the filing, BlueStar looks to add bolus and premixed insulin titration for type 2 diabetes to its comprehensive diabetes platform. In June, Welldoc announced FDA clearance for the BlueStar Insulin Adjustment Program for basal insulin titration. This current submission would expand insulin dosing support to include most types of insulin. The 510(k) was submitted on Nov 23, 2020.

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Dec 22,2020

DarioHealth Announces Agreement With Presbyterian Medical Services for Remote Patient Monitoring

DarioHealth Corp., a pioneer in the global digital therapeutics (DTx) market, announced that the Company has entered into an agreement to provide its remote patient monitoring (RPM) solution to Presbyterian Medical Services, one of the largest integrated healthcare systems in the State of New Mexico, effective January 1, 2021.

COLLABORATION PARTNERSHIP

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Dec 18,2019

Voluntis announces new pharma collaboration in oncology

Voluntis, a leader in digital therapeutics, announced today a collaboration with Novartis to evaluate the use of Voluntis’ digital therapeutic platform for Breast Cancer patients with the goal to empower patients with tools to more effectively manage symptoms and, thereby, improve patient experience and outcomes. This collaboration will leverage Voluntis’ Theraxium Oncology, the company’s core platform for digital therapeutics in the field of oncology.

COLLABORATION PARTNERSHIP

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Dec 18,2019

MassChallenge announces its startup class of 2020

This morning accelerator MassChallenge HealthTech named its class of 2020, which includes 27 startups from all over the world. This year’s list of companies includes everything from a VR-enabled digital therapeutic to care coordination products, such as Limbix, a West Coast digital therapeutics company that uses VR to help treat a variety of mental illnesses.

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Nov 22,2019

Roundup: 16 digital health studies, pilots and reviews from AHA 2019

From mobile ECGs to tele-rehabilitation to defibrillator delivery drones, a range of new data was on display at the American Heart Association Scientific Sessions 2019.

CLINICAL STUDY

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Jul 17,2019

Yale, Mayo Clinic, Biofourmis Launches Research to Detect Heart Failure Using Wearable Biosensor Data

Biofourmis has entered a research partnership with the Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI). Biofourmis’ mobile platform BiovitalsHFTM will be leveraged in a study of patients with heart failure to monitor functional capacity and quality of life to see if greater emphasis should be placed on these measures in the drug approval process.

COLLABORATION PARTNERSHIP

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Jul 31,2019

Voluntis announces market authorization for Oleena™, first digital therapeutic in oncology

Voluntis, a leader in digital therapeutics, today announced it has successfully completed a U.S. Food and Drug Administration (FDA) regulatory review of its Oleena™ software for oncology-related symptoms management and remote patient monitoring. Oleena™ is determined as Class II medical device falling under enforcement discretion per FDA Guidance. Oleena™ is a care companion for the cancer patient journey based on mobile and web technologies that enables self-management of symptoms and remote monitoring by care teams.

REGULATORY FDA

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