MEDICAL DEVICES

BD Acquires Scanwell Health, Inc. to Expand and Scale Digital At-Home Testing

BD | December 22, 2021

BD (Becton, Dickinson and Company), a leading global medical technology company, today announced it has completed the acquisition of privately held Scanwell Health Inc., a leader in smartphone-enabled at-home medical tests.BD collaborated with Scanwell to develop the app used with the recently launched BD Veritor™ At-Home COVID-19 Test, the first at-home COVID-19 test that uniquely uses a smartphone camera and app to capture and interpret results, eliminating the human subjectivity in other visually read at-home antigen tests. Scanwell will become the foundational digital platform upon which BD plans to develop at-home diagnostic tests for a range of infectious diseases including COVID-19/influenza A+B, group A strep and additional menu for detecting infections and managing chronic disease.

"The COVID-19 pandemic has accelerated the shift to new care settings, and BD is ready to deliver a smart, connected at-home diagnostic ecosystem to support traditional and telehealth providers and consumers. This acquisition will enable us to expand and scale our digital capabilities in-house to speed time to market for transformative at-home solutions now and in the future."

Dave Hickey, president of Life Sciences for BD

The Scanwell app is a key differentiator in the market for at-home COVID-19 testing. To date, no other company uses the phone's camera to capture the image of the test that is then analyzed and interpreted by the app. Other COVID-19 home tests use smartphones as part of their process, but BD Veritor™ At-Home COVID-19 Test is the first and only test to use the smartphone as the analyzer to digitally interpret the test results and provide a definitive POSITIVE or NEGATIVE digital display of testing results. The app also has the capabilities to securely store and report test results to organizations, including businesses, public health authorities and schools. The results of tests are stored in the app and can be referenced and displayed at any time by simply logging into the app.

Terms of the transaction were not disclosed. The transaction is expected to be immaterial to BD's fiscal 2022 financial results. Scanwell financial results will be reported under the Integrated Diagnostic Solutions business within the Life Sciences segment.

About the BD Veritor™ At-Home COVID-19 Test

The BD Veritor™ At-Home COVID-19 Test has not been FDA cleared or approved; but has been authorized by FDA under Emergency Use Authorization (EUA). This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of IVDs for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

About BD

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. 

Spotlight

Between 2012 and 2016, the OECD conducted a series of in-depth reviews of the policies and institutions that underpin the measurement and improvement of health care quality in 15 different health care systems (Australia, the Czech Republic, Denmark, England, Israel, Italy, Japan, Korea, Northern Ireland, Norway, Portugal, Scotland, Sweden, Turkey and Wales).


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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

Microbot Medical Announces Strategic Collaboration with Stryker Corporation to Develop the LIBERTY® Robotic System for Neurovascular Applications

Microbot Medical | December 28, 2021

Microbot Medical Inc.announced that it has entered into a strategic collaboration agreement with Stryker, a leading global medical technology company. The company will collaborate with Stryker’s Neurovascular division to integrate its neurovascular instruments with Microbot’s LIBERTY Robotic System to develop the world’s first dedicated robotic procedural kits for use in certain neurovascular procedures. “We have already ensured that the LIBERTY Robotic System has a strong and sustainable competitive advantage, and the collaboration with Stryker will allow us to further expand in the neurovascular space. I believe the similarities in our innovation culture, as well as our complementary core capabilities, will allow us to establish a truly differentiated solution that will benefit all stakeholders and accelerate our goal of changing the way robotic surgery is viewed and adopted.” Harel Gadot, Chairman, CEO and President of Microbot Medical The company will continue to develop the LIBERTY Robotic System independently for use in peripheral and coronary procedures. The animal feasibility studies to date support the company’s assertion that it will potentially allow physicians to safely and efficiently conduct remote catheter-based vascular procedures, and reduce the risk for radiation exposure, physical strain on the user and Hospital Acquired Infections (HAIs), without the need for cumbersome and expensive capital equipment. About Microbot Medical Microbot Medical Inc.is a pre-clinical medical device company that specializes in transformational micro-robotic technologies, focused primarily on both natural and artificial lumens within the human body. Microbot’s current proprietary technological platforms provide the foundation for the development of a Multi Generation Pipeline Portfolio (MGPP). Microbot Medical was founded in 2010 by Harel Gadot, Prof. Moshe Shoham, and Yossi Bornstein with the goals of improving clinical outcomes for patients and increasing accessibility through the use of micro-robotic technologies.

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HEALTH TECHNOLOGY

Komodo Health Introduces New Scientific Publications Management Software

Komodo Health | May 12, 2022

Komodo Health announced the launch of Komodo Publications Planning, introducing the next generation of publications planning and management applications for Life Sciences. The automated and highly customizable end-to-end software is designed to make it easier to maximize the impact and outcome of scientific publications and medical communications in an accurate, efficient, and compliant manner. With today’s news, Komodo extends the power of its real-world data and technology for Medical Affairs professionals, offering a comprehensive suite of applications to manage all aspects of publications planning, including a more data-driven approach to engaging with healthcare providers. In order to establish scientific integrity aligned to strategic medical objectives, global Medical Affairs teams are responsible for managing complex publication plans within Life Sciences companies, which can include both pipeline and commercial products or therapeutics with overlapping timelines. Multiple stakeholders need to seamlessly collaborate, provide feedback, and share updates with one another throughout the process, from publication concept through planning, and ultimately, publishing. With out-of-the-box connectors to Altmetric, Office 365, Unpaywall, and the ability to seamlessly integrate and optimize existing technology workflows, Komodo Publications Planning provides the tools to address every aspect of planning, execution, and analysis in a consolidated view to bring speed and ease for Medical Affairs teams. The integrated, user-friendly workflow enhances productivity by helping customers reduce time spent managing tasks to allow more time to focus on producing high-quality publications. For example, Pfizer was seeking a way to evolve and digitize how its publications were managed. The company developed a customized tool with Komodo Publications Planning as its foundation, which allowed Pfizer to roll out one cohesive publications management system that could be leveraged by a variety of stakeholders around the globe, creating a more efficient path for collaborating with authors and third-party agencies. With a consolidated view into its medical and scientific publication plans, Pfizer’s global team can automate the planning process, quickly tracking publication milestones and monitoring study progression using real-time alerts. “Working in partnership with Komodo on designing and building a new publications management system has been an exciting and courageous journey. We were able to realize some of the innovative solutions we wanted to incorporate into our system to advance our publications practice,” Catherine Skobe, MPH, Sr. Director, Publications Innovative Solutions Lead at Pfizer “Legacy publications management applications often require long build cycles and offer limited control; Komodo Publications Planning is helping our customers eliminate the need for multiple, disjointed systems, which often cause timely and costly delays for publishing critical clinical advancements,” said Prasad Kanumury (PK), Mavens founder and General Manager at Komodo Health. “The ability to integrate into existing IT infrastructure is helping Medical Affairs teams to more effectively achieve their scientific objectives and produce timely, journal-accepted publications within a single, customizable solution.” Stemming from the 2021 acquisition, Mavens' integration into Komodo has resulted in a number of new opportunities for enterprise impact. The release of Komodo Publications Planning marks the first new application within Komodo’s Medical Affairs Suite. The Medical Affairs Suite offers end-to-end workflow support on everything from optimizing publications, impact reporting, and clinical education to enabling HCPs with disease burden intelligence and advanced analytic solutions to build comprehensive, measurable, and evidence-based strategies. The suite also allows for strategic engagement opportunities through key expert identification within Komodo’s Aperture application, now with Medical Information Cloud integration, to encourage even more timely, compliant, and trackable clinical interactions. The launch of Komodo Publications Planning coincides with the 18th Annual ISMPP Meeting, where experts from Komodo Health and Pfizer presented about the future evolution of the medical publications ecosystem in a session on May 9th. For more information, visit Komodo Health onsite at booth #14. About Komodo Health Komodo Health is a technology platform company creating the new standard for real-world data and analytics by pairing the industry’s most complete view of patient encounters with enterprise software and machine learning that connects the dots between individual patient journeys and large-scale health outcomes. Across Life Sciences, payer, provider, and developers, we help our customers unearth patient-centric insights at scale — marrying clinical data with advanced algorithms and AI-powered software solutions to inform decision making, close gaps in care, address disease burden, and help the enterprise create a more cost-effective, value-driven healthcare system.

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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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Spotlight

Between 2012 and 2016, the OECD conducted a series of in-depth reviews of the policies and institutions that underpin the measurement and improvement of health care quality in 15 different health care systems (Australia, the Czech Republic, Denmark, England, Israel, Italy, Japan, Korea, Northern Ireland, Norway, Portugal, Scotland, Sweden, Turkey and Wales).

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