Oct 30,2024 TOP STORY

Click Therapeutics Launches Software-Enhanced Drug™ Therapies as part of new Click SE™ Offering

Click Therapeutics has launched Click SE™, a new line of Software-Enhanced Drug™ therapies combining digital therapeutics with traditional medications, marking a pioneering step in digital health. These innovative therapies integrate Click’s AI-driven digital platforms with pharmacotherapy to enhance drug efficacy, targeting specific patient needs. The Click SE™ offerings align with recent FDA guidance encouraging software applications that support drug effectiveness, potentially improving patient outcomes. By adding a digital layer, these "smart" medications could become a standard in healthcare, enabling physicians to choose between traditional or software-enhanced versions of drugs for personalized patient care.

PRODUCT

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Sep 17,2024

Leveraging 'explainable AI' to resolve Japan's growing stroke threat

Cardio Intelligence, a Japanese startup, has developed AI-powered solutions for detecting atrial fibrillation (AFib), a common but often undetected risk for stroke. Their AI system, SmartRobin AI, can analyze large ECG datasets, producing rapid 24-hour and 7-day ECG analyses. CEO Yuichi Tamura explains that their AFib detection AI, approved in Japan, improves diagnosis of paroxysmal AFib, which often presents without symptoms. With a detection sensitivity of 97% and specificity of 95%, the AI is being adopted in hospitals. The company plans to expand globally, particularly into Asia and North America, to improve cardiac care.

PRODUCT

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Jun 26,2024

Boston Scientific's DBS software gains CE as Parkinson's treatments advance

Boston Scientific has received the CE mark for its Vercise Neural Navigator 5 software, part of its Deep Brain Stimulation (DBS) system for treating Parkinson's disease. This milestone highlights the trend towards integrating advanced technology and AI in managing neurological conditions, in line with the FDA's call for innovation in Parkinson's treatments. The neurological devices market, valued at $12.5 billion in 2023, is projected to grow to $20.9 billion by 2033, driven by the demand for advanced diagnostic and monitoring tools. Innovations like Boston Scientific’s software and wearable technologies, such as those utilizing Apple Watch data, are enhancing therapeutic interventions and promoting a comprehensive approach to disease management. This shift towards high-tech solutions marks a significant advancement in personalized and effective neurological care.

REGULATORY CE MARK

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Jun 10,2024

Aptar Digital Health Partners with SHL Medical to Optimize Patient Experience with Self-Injectable Therapies

Aptar Digital Health has partnered with SHL Medical to enhance the patient experience for self-injectable therapies. Aptar, known for its digital health solutions and connected devices, will integrate its Software as a Medical Device (SaMD) platform with SHL’s advanced drug delivery systems, including the Molly® Connected Cap autoinjector. This collaboration aims to provide comprehensive digital support, empowering patients during their treatment journey. The partnership will develop end-to-end solutions for the pharmaceutical industry, improving patient adherence and experience with self-injected medications.

COLLABORATION PARTNERSHIP

#connected device

#software

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Jan 16,2024

Significo Takes Over Piobyte and Continues Its Path in Redefining Digital Health Products

Significo GmbH, a data-based, user-centered healthcare software company, announces the strategic acquisition of the renowned software development company Piobyte. The Potsdam-based company Piobyte, founded in 2010, develops software solutions for web portals, hardware integrations and mobile apps. The company has extensive experience in healthcare compliance and digital therapeutics. Significo develops digital health solutions that empower as many people as possible to positively influence their health. Significo offers both tailor-made products and apps for licensing and their adaptation to individual customer needs. The acquisition enables Significo to offer a more comprehensive service, products and solutions for German health funds and insurers, large employers, the pharmaceutical industry and consumers.

COLLABORATION MERGERS & ACQUISITION

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Jan 04,2024

BlueSkeye AI Launches Groundbreaking Technology Using Mobile Devices to Analyze Facial Expressions and Vocal Behavior for Clinical Use at CES 2024

UK startup Blueskeye AI is launching its Health Foundation Platform at the Consumer Electronics Show in Las Vegas held in between January 9-12 in Las Vegas. The Health Foundation Platform makes it easy and quick for health tech companies to integrate clinical grade AI which analyses medically relevant expressed behavior into their products. Their technology uses mobile phones or tablets running advanced machine learning algorithms to analyze facial expressions and vocal behavior to provide digital health companies and their customers with deeper, more measurable and reliable customer insights more securely and faster than ever before. The powerful clinical grade AI can be integrated rapidly into digital therapeutics platforms, clinical trial or treatment companion apps, extending their capabilities, making them more powerful and allowing additional services to be offered. The Platform can also assess fatigue, pain, muscular atrophy, anxiety and depression. It could even identify the early signs of conditions which have an effect on the face or voice, such as, Autism, ADHD, Parkinson's or Alzheimer's. The Platform's core technology is already in use in the UK's NHS Trusts where the company is undertaking a clinical trial of its use for assessing anxiety and depression amongst pregnant women.

PRODUCT

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Apr 28,2021

MedRhythms Initiates Clinical Trial and Expands Pipeline into Acute Stroke

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. The trial will be in partnership with UMass Memorial Healthcare and will examine the impact of MR-010 on acute stroke walking outcomes. This trial is funded by UMass and will be led by Dr. Brian Silver, Interim Chair in the Department of Neurology. It will assess the feasibility of MR-010 to address walking impairments in those in the acute phase of stroke. The study will consist of two phases: the first phase will look at the impact of MR-010 within the acute hospital setting, and the second phase will look at the continued impact of the therapeutic post-discharge.

COLLABORATION PARTNERSHIP

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Jul 18,2023

Astellas and Eko Health Announce Agreement to Incorporate Next Generation Eko CORE 500™ Digital Stethoscope into Z1608

Astellas Pharma and Eko Health signed a License & Supply Agreement for the global supply and license of Eko's latest digital stethoscope, the CORE 500™, and a custom suite of Eko's AI-powered cardiovascular disease detection software. Working collaboratively with Welldoc, Astellas intends to integrate Eko's technology with Welldoc's cardiometabolic digital therapeutic (DTx) capabilities to create a non-invasive device-DTx solution for patients with heart failure, currently known as Z1608, waiting for the FDA approval. This solution will enable remote monitoring and automated coaching to reduce acute decompensation events.

COLLABORATION PARTNERSHIP

#connected device

#software

#mobile app

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Jan 01,2022

Amalgam Rx’s DoseCheck Receives SFDA Clearance in Saudi Arabia

Amalgam Rx, Inc., the leader in connecting healthcare providers and life sciences companies through a SaaS-enabled digital marketplace and product platform, announced that its insulin titration solution, DoseCheck, will now help patients and their care teams manage their insulin and glucose in yet another country.

PRODUCT

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May 11,2023

Wellthy Therapeutics Announces Expansion into the United States - Completes FDA CFR Part 11, FDA CFR Part 820, and HIPAA Certification for Its Platform

Wellthy Therapeutics has completed FDA certifications, including FDA 21 CFR Part 11, FDA 21 CFR Part 820, and HIPAA certification, for its digital health platform. These certifications demonstrate the company's commitment to data security, privacy, quality, and regulatory compliance. With existing compliance with other international standards, Wellthy Therapeutics aims to provide globally compliant digital health solutions to improve patient outcomes and address unmet needs. The platform simplifies the ability for pharma, HUBs, providers, and health plans to launch and scale globally compliant digital health and SaMD solutions. Clients leverage the platform to configure and commercialize their own customized digital health and SaMD solutions that are deployable in a matter of weeks and at a fraction of traditional costs, while addressing their specific business goals and complex patient needs. Over 150,000 patients have benefitted from Wellthy Therapeutics' platform so far, highlighting the value that the company's platform brings, and its continued leadership in the clinical outcomes and patient engagement space.

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