Jan 04,2024

Aptar Digital Health and Gerresheimer Collaborate to Develop Integrated Solution for Subcutaneous Cancer Therapy

Aptar Digital Health announced a new collaboration with Gerresheimer, an innovative systems and solutions provider and global partner to the pharma, biotech and cosmetics industries, to develop a tailored solution to support patients and health care professionals in cancer therapy management. By connecting Aptar Digital Health’s proprietary SaMD platform with Gx SensAir, Gerresheimer’s on-body device for the subcutaneous delivery of large biologics molecules, this integrated solution is intended to improve overall treatment adherence and clinical outcomes. More specifically, it aims to make remote patient monitoring easier, and facilitate the onboarding of patients to new therapies, helping them to better manage adverse effects. For pharmaceutical companies, this collaboration is an opportunity to offer a more patient-centric solution, and tackle potential challenges, such as treatment interruptions or discontinuations related to administration issues or adverse effects. This solution will also support the transition from intravenous to subcutaneous administration of oncology drugs. This integrated solution will first be designed for targeted anti-cancer therapies such as PD-1/PDL-1, CTLA-4, with the potential to expand to all therapies delivered subcutaneously.

COLLABORATION PARTNERSHIP

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Jan 18,2024 TOP STORY

Aptar Digital Health and Moffitt Cancer Center Launch Clinical Evaluation for Oncology Digital Therapeutic, Oleena®

Aptar Digital Health announced a collaboration with Moffitt Cancer Center, a leading U.S. cancer care and research institution, to conduct a clinical evaluation of Oleena®, Aptar Digital Health’s FDA approved and CE-marked digital therapeutic (DTx) for the management of symptoms in cancer care. The clinical evaluation, which will begin in February 2024 and run for a total period of 15 months, will primarily assess the usability of Oleena® by measuring key indicators such as patient satisfaction and engagement, as well as clinical outcomes including symptom burden, anti-cancer treatment adherence and quality of life. Under this clinical evaluation, head and neck cancer patients being treated with chemoradiation will use Aptar Digital Health’s Oleena® DTx to guide them in self-managing their symptoms.

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Jan 04,2024 TOP STORY

Aptar Digital Health and Gerresheimer to Develop Integrated Cancer Therapy Solution

Aptar Digital Health announced a new collaboration with Gerresheimer, an innovative systems and solutions provider and global partner to the pharma, biotech and cosmetics industries, to develop a tailored solution to support patients and health care professionals in cancer therapy management. By connecting Aptar Digital Health’s proprietary SaMD platform with Gx SensAir, Gerresheimer’s on-body device for the subcutaneous delivery of large biologics molecules, this integrated solution is intended to improve overall treatment adherence and clinical outcomes. More specifically, it aims to make remote patient monitoring easier, and facilitate the onboarding of patients to new therapies, helping them to better manage adverse effects. For pharmaceutical companies, this collaboration is an opportunity to offer a more patient-centric solution, and tackle potential challenges, such as treatment interruptions or discontinuations related to administration issues or adverse effects. This solution will also support the transition from intravenous to subcutaneous administration of oncology drugs. This integrated solution will first be designed for targeted anti-cancer therapies such as PD-1/PDL-1, CTLA-4, with the potential to expand to all therapies delivered subcutaneously.

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Dec 11,2023

Predicting Rescue Medication Use to Help Prevent Exacerbations: The Intersection of AI, Data, and Asthma Management

A recent study examined over 13,000 asthma participants utilizing Propeller's FDA-cleared digital therapeutic platform. Analyzing more than 1.2 million days of data, the study revealed that digital health platforms, combined with predictive models, can effectively collect, analyze, and predict trends in asthma rescue medication usage, a key indicator of impending exacerbations. The study employed machine learning models, including a temporal-convolutional neural network, which demonstrated an impressive performance in predicting days with increased short-acting beta agonist (SABA) medication use. Further research is warranted to validate these findings in real-world applications.

CLINICAL STUDY

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Aug 11,2022

Frontiers in Digital Health Publication Presents Feel Therapeutics Program as a New Strategy for Effectively Monitoring and Improving Anxiety and Depression

Feel Therapeutics announced the publication in Frontiers in Digital Health of a landmark clinical feasibility study showing the effectiveness of Feel’s intervention program for anxiety and depression. The study presented the results from real-world-data to evaluate different aspects of the Feel Program, which is a 16-week, fully-remote, digital mental health support program created by Feel Therapeutics to bring objective data and precise support into the management of mental health. In this study, 48 participants suffering from mild or moderate Major Depressive Disorder (MDD) and Generalized Anxiety Disorders (GAD) symptoms participated in the Feel Program and were assessed across three key metrics: feasibility of the program, participant engagement, and symptom improvement. The results demonstrated a high average precision level (87%) in identifying emotional events passively through the wearable device. Furthermore, the study showed high engagement rates of >60 minutes per week of app usage, and 4 out of 5 participants were very likely to recommend the program.

CLINICAL STUDY

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Dec 06,2023 TOP STORY

Jasper Health Unveils Medicare Focused Cancer Care Navigation Leveraging AI, Aligned with New Reimbursement Codes

Jasper Health launched a Cancer Care Navigation and Supportive Care Solution, aimed at transforming oncology navigation support for Medicare populations, in sync with CMS’s recent announcement to reimburse Health-Related Social Needs. “Patient Navigators serve as the guiding light for individuals navigating the intricate landscape of a cancer diagnosis and treatment. In this new reimbursable model, we will be offering high-touch, wrap-around navigation virtually. Our specialty-trained Cancer Care Navigators directly match with affected individuals, providing empathetic guidance and tailored resources every step of the way,” says Holly Spinks, Chief Clinical & Compliance Officer at Jasper Health. Jasper currently offers seniors a multi-channel navigation service that includes a digital planner and dedicated Care Navigator. To enable cancer navigation at scale, this is paired with Jasper Compass, the AI-driven Cancer Care Management Platform, which allows targeted, efficient, and personalized approach to managing patient care, helping the Navigators optimize resources and interventions based on individual patient needs, ultimately leading to improved outcomes. “Jasper Compass is now available for payors, health systems, and provider partners. This fully customizable and white-labeled platform empowers care professionals to enhance overall outcomes by improving the coordination of patient care,” stated Spinks.

PRODUCT

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Nov 21,2023

Innovative digital therapeutics program shows a reduction in hospitalizations and costs for heart failure patients

The CONTINUUM program, a remote patient monitoring and digital therapeutics project led by The Centre hospitalier de l'Université de Montréal (CHUM), helped heart failure outpatients achieve a significant reduction in the number of emergency room visits and/or hospitalizations and demonstrated a 23% reduction in healthcare costs, according to preliminary results presented at the American Heart Association's Scientific Sessions, held November 11–13, 2023. The three-month randomized controlled trial for heart failure outpatients at risk of hospitalization evaluated the CONTINUUM program versus standard of care alone. This program included: A self-care app via smartphone or tablet where patients entered vital signs, weight, and heart failure symptoms; Remote monitoring of these data by the CHUM's clinical nurses; Digital therapeutics automated medication suggestions sent to the treating medical team; and Heart failure educational modules for patients – all based on Greybox Solutions' Takecare platform. The preliminary results show that the number of ER visits and/or hospitalizations (all cause) per patient was 0.19±0.47 for the intervention group and 0.55±0.89 for the control one. The CONTINUUM program is a partnership between the Centre hospitalier de l'Université de Montréal (CHUM), the CHUM Research Centre, MEDTEQ+, Greybox Solutions, Mitacs, PROMPT, and Boehringer Ingelheim (Canada).

CLINICAL STUDY

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Nov 21,2023 TOP STORY

Huma obtains multi-condition Saudi FDA Class C regulatory certification for its configurable SaMD disease management platform

Huma Therapeutics announced today that it has received Saudi FDA Class C certification for a disease-agnostic Software as a Medical Device (SaMD) in Saudi Arabia. Huma's SaMD platform powers digital health pathways through which data are collected from patients for self-management or to be assessed centrally by clinicians. These include remote patient monitoring (RPM) programmes, companion apps, risk assessment tools, dose calculators, algorithms. With the recent attainment of Saudi FDA Class C certification, complementing its existing Class IIb regulatory certification in the EU and Class II 510(k) in the USA, the SaMD platform reaches a new pinnacle in patient care versatility. This achievement enables the platform to monitor patients across all age groups, including infants and those pregnant, and seamlessly integrates with various external devices such as heart rate and blood sugar monitors, and smart inhalers. Beyond facilitating disease self-management for patients, the platform is equipped to aid clinicians in managing critical and serious conditions, including heart failure, COPD, asthma, cancer, rare diseases, pre-/post-op monitoring and more.

REGULATORY SAUDI FDA

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Nov 20,2023 TOP STORY

Careology's Digital cancer care: working with Nuffield Health to improve care for patients

In February 2022, Careology worked with Nuffield Health to demonstrate how cancer care could be improved through the use of connected remote monitoring and engagement technology. As part of the partnership, cancer patients at Nuffield Health Derby Hospital had access to a fully digital care support solution, allowing them to track their symptoms, vital signs and wellbeing measures. Patients logged their symptoms such as pain, nausea and vomiting within Careology. On average over 65% of the patients who used the Careology app each month logged how they were doing and engaged in self-care. . Careology’s remote monitoring technology enabled Nuffield Health’s nurses to look after their patients in a safe, scalable and efficient manner through a dashboard as part of Careology Professional. Nurse engagement data reported a 100% adoption rate of Careology Professional. The digitisation of questionnaires such as Holistic Needs Assessments (HNAs) meant patients were more forthcoming in filling them out as they were easy to access on the app at any time, despite patients being sick or having limited experience with technology. Following the successful pilot at Nuffield Health Derby Hospital which ended in October 2022, Nuffield Health will now complete a full rollout of Careology’s platform across their sites nationwide.

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Oct 13,2023

British digital health start-ups HUMA and CyberLiver win in Las Vegas

A quartet of British digital health start-ups were named among the winners at the Digital Health Hub Awards at HLTH in Las Vegas on Monday. Thirteen Best in Class winning companies and twenty-seven Rising Star companies were named across nine categories. Huma Therapeutics was named Best in Class Winner in the Remote Diagnostic Tool or Device category. Huma Therapeutics, previously Medopad, has been granted multi-condition US FDA 510(k) Class II regulatory clearance for its configurable SaMD disease management platform. Additionally CyberLiver was named a rising star in the Clinical Diagnostic Device, Platform or Tool Category. CyberLiver are developing digital therapies for the treatment of advanced liver disease, with a series of clinical trials underway in the NHS.

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