Boston Scientific Launches Connected Patient Challenge, a Search for Digital Tools to Better Manage Chronic Conditions

Inside Digital Health | September 30, 2019

Boston Scientific Launches Connected Patient Challenge, a Search for Digital Tools to Better Manage Chronic Conditions
As healthcare shifts from the inpatient setting to outside the four walls of a health facility, innovations allow patients with chronic conditions to manage their health from the comfort of their own homes. Technologies such as mobile health apps and wearables give patients more control over both their treatment plans and their health data. In the vein of innovation, Boston Scientific announced its fifth annual Connected Patient Challenge, a campaign seeking digital health solutions that improve patient care and better manage chronic conditions. “Events like this are so critical to raising awareness of the world of the possible and how you can drive really meaningful innovation,” David Feygin, Ph.D., MBA, the vice president of IT and Chief Digital Health Officer at Boston Scientific, said at the 2018 event. The challenge will bring together providers, institutions, patients, payers, and researchers from across the healthcare ecosystem with the goal of better understanding pain points in healthcare and how digital solutions can augment care for patients living at home with chronic diseases.

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HEALTH TECHNOLOGY

Texas Children's Hospital And Baylor College of Medicine COVID-19 Vaccine Technology Secures Emergency Use Authorization In India

Texas Children Hospital | December 29, 2021

Texas Children's Hospital and Baylor College of Medicine announced today that CORBEVAX™, a protein sub-unit COVID-19 Vaccine, whose technology was created and engineered at its Center for Vaccine Development (CVD), has received Emergency Use Authorization (EUA) approval from the Drugs Controller General ofIndia(DCGI)to launch inIndiawith other underserved countries to follow. Dubbed "The World's COVID-19 Vaccine", it uses a traditional recombinant protein-based technology that will enable its production at large scales making it widely accessible to inoculate the global population. The initial construct and production process of the vaccine antigen was developed at Texas Children's Hospital CVD, led by co-directors Drs. Maria Elena Bottazzi and Peter Hotez and in-licensed from BCM Ventures, Baylor College of Medicine's integrated commercialization team, to Hyderabad-based vaccine and pharmaceutical company Biological E. Limited (BE). CORBEVAX™ after completing two Phase III clinical trials involving more than 3000 subjects was found to be safe, well tolerated and immunogenic: CORBEVAX™ demonstrated superior immune response in comparison with COVISHIELD™ vaccine when assessed for Neutralizing Antibody (nAb) Geometric Mean Titers (GMT) against the Ancestral-Wuhan strain and the globally dominant Delta variant. CORBEVAX™ vaccination also generated significant Th1 skewed cellular immune response. CORBEVAX™ nAb GMT against Ancestral-Wuhan strain is indicative of vaccine effectiveness of >90% for prevention of symptomatic infections based on the Correlates of Protection assessment performed during Moderna and Astra-Zeneca vaccine Phase III studies. CORBEVAX™ nAb GMT against the Delta strain indicates a vaccine effectiveness of >80 percent for the prevention of symptomatic infections based on published studies. While none of the subjects who took CORBEVAX™ or COVISHIELD™ had serious adverse events, CORBEVAX™ had 50 percent fewer adverse events than COVISHIELD™. In the continuous monitoring of phase II studies, CORBEVAX™ showed high persistence of immune response as indicated by <30% drop in nAb GMT till 6 months second dose as compared to >80% drop observed with majority of the vaccines. "Protein-based vaccines have been widely used to prevent many other diseases, have proven safety records, and use economies of scale to achieve low-cost scalability across the world," said Dr. Maria Elena Bottazzi, Professor and Associate Dean of the National School of Tropical Medicine at Baylor and Co-Director of the Texas Children's Hospital Center for Vaccine Development. "Our decade-long studies advancing coronavirus vaccine prototypes has led to the creation of this vaccine, which will fill the access gap created by the more expensive, newer vaccine technologies and that today are still not able to be quickly scaled for global production." The need for safe, streamlined, low-cost vaccines for middle- to low-income countries is central to the world's fight against the COVID-19 pandemic. Without widespread vaccination of populations in the Global South, additional virus variants will arise, hindering the progress achieved by currently available vaccines in the United States and other Western countries. "This announcement is an important first step in vaccinating the world and halting the pandemic. Our vaccine technology offers a path to address an unfolding humanitarian crisis, namely the vulnerability the low- and middle-income countries face against the delta variant," said Dr. Peter Hotez, Professor and Dean of the National School of Tropical Medicine at Baylor and Co-Director of the Texas Children's Hospital Center for Vaccine Development. "Widespread and global vaccination with our Texas Children's-Baylor-BE vaccine would also forestall the emergence of new variants. We have previously missed that opportunity for the alpha and delta variant. Now is our chance to prevent a new global wave from what might follow." "Over the years, we have worked to make quality vaccines and pharmaceutical products accessible to families around the world. With this as our backdrop, we resolved to develop an affordable and effective COVID-19 vaccine. It has now become a reality. We deeply appreciate Texas Children's Hospital Center for Vaccine Development, Baylor, CEPI, the Bill and Melinda Gates Foundation, and the government of India for their continuous support and cooperation during this journey. The combined efforts & unceasing support demonstrate that we can collectively overcome any challenge". Mahima Datla, Managing Director, Biological E. Limited ABOUT TEXAS CHILDREN'S HOSPITAL Texas Children's Hospital, a not-for-profit health care organization, is committed to creating a healthier future for children and women throughout the global community by leading in patient care, education and research. Consistently ranked as the best children's hospital in Texas, and among the top in the nation, Texas Children's has garnered widespread recognition for its expertise and breakthroughs in pediatric and women's health. The hospital includes the Jan and Dan Duncan Neurological Research Institute; the Feigin Tower for pediatric research; Texas Children's Pavilion for Women, a comprehensive obstetrics/gynecology facility focusing on high-risk births; Texas Children's Hospital West Campus, a community hospital in suburban West Houston; and Texas Children's Hospital The Woodlands, the first hospital devoted to children's care for communities north of Houston. The organization also created Texas Children's HealthPlan, the nation's first HMO for children; has the largest pediatric primary care network in the country, Texas Children's Pediatrics; Texas Children's Urgent Care clinics that specialize in after-hours care tailored specifically for children; and a global health program that's channeling care to children and women all over the world. Texas Children's Global Health program leads efforts that advance health care equity through innovative collaboration in care, education and research for underserved populations globally. Texas Children's Hospital is affiliated with Baylor College of Medicine. ABOUT TEXAS CHILDREN'S HOSPITAL CENTER FOR VACCINE DEVELOPMENT Texas Children's Hospital Center for Vaccine Development is one of the leading vaccine development centers in the world. Established in Washington DC as the Sabin Vaccine Institute Product Development Partnership (PDP) in the year 2000 and after relocating to the Texas Medical Center in 2011, it rebranded as Texas Children's Center for Vaccine Development. For the past two decades it has acquired an international reputation as a non-profit PDP, advancing vaccines for poverty-related neglected tropical diseases (NTDs) and emerging infectious diseases of pandemic importance. In addition, it builds and strengthens capacity for vaccine development locally and with foreign nations and leads global efforts to guide and influence vaccine policy and advocacy through "vaccine diplomacy" as an international bridge for peace and vaccine development capacity. ABOUT BCM VENTURES Baylor College of Medicine Ventures is the commercial engine of the health sciences university, created to support the translation of academic knowledge and intellectual assets for the benefit of society. We do this by engaging university innovators, entrepreneurs and industry to fully develop ideas along their best commercial path. We foster a culture of commercialization and engage with industry to identify market opportunities for collaborative ventures. ABOUT BIOLOGICAL E. LIMITED Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio. In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

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HEALTH TECHNOLOGY

Alkem Laboratories Ltd. to Launch State of the Art Technology for Diabetic Foot Ulcer Management

Alkem Laboratories Ltd. | January 13, 2022

Alkem Laboratories Ltd. (Alkem) hereby announces to launch a unique patented technology for the treatment of Diabetic Foot Ulcer (DFU) in India. The solution would be based on disruptive 4D Bioprinting technology, which would be used to treat deep, non-healing chronic wounds and is expected to be launched in the Indian market in the latter half of 2022 post regulatory approval. This advanced technology for DFU management has a high scope of preventing amputations in diabetic patients. This technology will be available at affordable rates to Indian patients at a time when there is no definitive treatment for DFU in India. India currently has approximately 77 mn diabetes patients, the second highest in the world. A diabetic foot ulcer is one of the most significant and devastating complications of diabetes and is defined as a foot affected by ulceration that is associated with neuropathy and/or peripheral arterial disease of the lower limb in a patient with diabetes. Approximately, 12-15% with diabetes suffer from DFU at least once in a lifetime. 5–24% of them will finally lead to limb amputation within 6–18 months after the first evaluation. The risk of foot ulceration and limb amputation increases with age and the duration of diabetes. Alkem has collaborated with Rokit Healthcare Inc. to commercialize the technology in India to help reduce amputation amongst DFU patients considering the negative impact of amputation on a patient's quality of life and the associated economic burden on the healthcare system. "In India, Diabetes is one of the major healthcare challenges. The challenge in itself is so huge that diabetic foot ulcers often get ignored. Approximately 1 lac people have to undergo amputation every year and compromise on their quality of life. To address the problem, Alkem has collaborated with Rokit Healthcare Inc., a global regenerative solutions company, to bring out novel solutions for the management of diabetic foot ulcers." Mr. Sandeep Singh, Managing Director, Alkem Laboratories Ltd Adding further, Mr. Sandeep asserted, "Alkem, over the years, has always been at the forefront in delivering high-quality patient care, through its innovation and patient-centric initiatives." About Alkem Laboratories Ltd Established in 1973 and headquartered in Mumbai, Alkemis a leading Indian pharmaceutical company with global operations, engaged in the development, manufacture, and sale of pharmaceutical and nutraceutical products. The Company produces branded generics, generic drugs, active pharmaceutical ingredients (APIs), and nutraceuticals, which it markets in India and International markets. With a portfolio of more than 800 brands in India, Alkem is ranked the fifth largest pharmaceutical company in India in terms of domestic sales. The Company also has presence in more than 40 international markets, with the United States being its key focus market.

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MEDICAL DEVICES

Medtronic announces regulatory approval and launch in Japan of Micra AV Transcatheter Pacing System

Medtronic | January 11, 2022

Medtronic plc, a global leader in healthcare technology,today announced it has received approval fromJapan'sMinistry of Health, Labor and Welfare for the sale and reimbursement of the Micra™ AV Transcatheter Pacing System (TPS), and the company will launch the product this month. This approval expands the number of patients inJapan– one of the largest markets in the world – who are eligible to receive the Micra TPS, the world's smallest pacemaker. The Micra AV is indicated for the treatment of patients with AV block, a condition in which the electrical signals between the chambers of the heart (the atria and the ventricle) are impaired. The Micra TPS is the first-ever leadless pacemaker; its first version (the Micra VR) was approved inJapanin 2017 for patients who only require single-chamber pacing. "Pacemakers have made significant progress over their approximately 60-year history, including miniaturization, improvements in pacing technology, MRI compatibility, and remote monitoring," explainedKyoko Soejima, professor of cardiovascular internal medicine at Kyorin University Hospital and a member of the Micra TPS Global Clinical Trial steering committee. "The first Micra system transformed the concept of pacemakers by eliminating surgical pockets and leads, and Micra AV promises to deliver the benefits of leadless pacing to a larger number of patients because ventricular pacing can be performed synchronously with the atrium." Historically, patients with AV block have been treated with traditional dual-chamber pacemakers which are implanted in the upper chest, under the skin below the collar bone, and connected to the heart using thin wires called "leads." Identical in size and shape to the original Micra TPS, Micra AV has several additional algorithms which detect cardiac movement, allowing the device to adjust pacing in the ventricle to coordinate with the atrium, providing "AV synchronous" pacing therapy to patients with AV block. The Micra AV approval is based on data from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study, which evaluated the safety and effectiveness of accelerometer-based atrial sensing algorithms. The study evaluated the ability of the Micra's internal sensor to monitor and detect atrial contractions and enable coordinated pacing between the atrium and ventricle, thereby providing AV synchrony. "Since introducing the first battery-powered external pacemaker in 1957 to the innovative Micra leadless pacemaker portfolio, Medtronic continues to pioneer pacing innovations for physicians and their patients." Rob Kowal, M.D., Ph.D., chief medical officer of the Cardiac Rhythm Management business at Medtronic About the Micra Transcatheter Pacing Systems (TPS) The Micra TPS received CE Mark inApril 2015and U.S. FDA approval in 2016. Comparable in size to a large vitamin, Micra is less than one-tenth the size of traditional pacemakers yet delivers advanced pacing technology to patients via a minimally invasive approach. During the implant procedure, the device is attached to the heart with small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device. Unlike traditional pacemakers, Micra does not require leads or a surgical "pocket" under the skin, so potential sources of complications related to leads and pockets are reduced, and there is no visible sign of the device. About Medtronic Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered inDublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary.

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DIGITAL HEALTHCARE

Hekka Labs Introduces the First Decentralized Chronic Disease Data Management Ecosystem in South Asia

Hekka Labs | January 15, 2022

Hekka Labs launches a game changing decentralized healthcare ecosystem for a far more efficient health record management. The firm will concentrate on the Southeast Asia market, starting with India, where it will establish the largest chronic disease data management network. Hekka then intends to connect to the rest of the world's healthcare market through the design and implementation of proprietary Distributed Ledger Technology (DLT). Hekka has cemented initial partnerships with 3 Indian healthcare solution providers, Curisin, a healthcare company with a wide network of 30 million patients and 40,000 partnered doctors which as recently agreed to provide a minimum of 1.5 million medical records in 2022. A further agreement to provide up to 20 separate blood biomarkers together with Covid 19 data on 100,000 patients, will form the basis of an initial trial for its blockchain audit trail platform. IMMUNIDEX, a healthcare solution provider offering tests and applications that are driven by proprietary AI that can identify early immune-related risks and is well placed to capture highly valuable data for the Hekka network. TELEMEDICINE INDIAN CO, a start-up offering multi telemedicine services, multiple blood tests, and health screening including COVID-19 testing will form another integral part of data generation for the Hekka ecosystem. Hekka Labs with the integration of Distributed Ledger Technology (DLT) offers a plug and go solution that allows users to interact with the HEKKA ecosystem without major disruption. This set up can solve the inherent problems that occur on a regular basis in the healthcare industry such as inefficient biomarker management, document hogging and unstructured data management. Hekka Labs has set out to become the leading chronic illness and immunology platform in India. Hekka's private and public blockchain network solution will generate a new trust in Indian healthcare data management and can open up significant opportunity for both the domestic and global collaboration. This will lead to new levels of ethical standards and excellence for the Indian healthcare market. In the long run, Hekka plans to evolve as a significant decentralized healthcare ecosystem by connecting the network of medical and associated healthcare providers culminating in a targeted community of over 500 million patients. As a result, tens of billions of chronic disease digital biomarkers can be made available for Deep Learning, potentially speeding up new healthcare discoveries. HEK is the native token of the Hekka ecosystem, which is launched in the Ethereum network's ERC-20 standards for its intensive security and global reputation, ensuring the confidence of delivering the most sophisticated healthcare data management service. The HEK token is a token complimented by an ATOM token (Points) system which is the primary source of HEKKA 's data transfers. This ensures the value of the token. The HEK token will be a key component in serving all prospective users' interactions with the platform's different levels of service.

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