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Philips launches pre-hospital wireless monitoring solution for emergency medical response in U.S.

Philips launches pre-hospital wireless monitoring solution for emergency medical response in U.S.

Royal Philips, a global leader in health technology, announced the launch of its remote monitoring and defibrillator solution (Tempus ALS) for pre-hospital settings in the U.S. The solution is a complete end-to-end system that combines innovative hardware and advanced software to expand the pre-hospital scope of care for first responders. The professional defibrillator (Tempus LS-Manual) is the final element of the overall solution to receive 510(k) clearance from the U.S. FDA and is now available for sale in the U.S. market.

As a unique modular platform, the remote monitoring and defibrillator solution (Tempus ALS) consists of a remote portable vital signs patient monitor (Tempus Pro), and remote professional defibrillator (Tempus LS-Manual). While the monitor and defibrillator can be used separately, the devices also connect wirelessly to share data and transfer vitals, waveforms and images into Philips web-based software platform (IntelliSpace Corsium). The software platform provides robust, real-time transfer of clinical data and events, interactive ECG measurement, two-way communication and more, enabling rapid clinical and transport decision support and seamless electronic patient care recording (ePCR) integration outside the hospital in emergency settings.

โ€œIn emergency situations, where seconds count, having access to advanced patient data collection and sharing and real-time secure data streaming, can help inform confident treatment and transport decisions outside the hospital,โ€ said Arman Voskerchyan, General Manager of Therapeutic Care at Philips. โ€œThe integrated remote monitoring and defibrillator solution combined with our web-based software platform will help front line responders provide emergency care, diagnosis and treatment – including defibrillation therapy, data management and clinical and operational efficiency features โ€“ in a fully integrated solution.โ€

Emergencies and care events outside the hospital continue to rise, with an estimated 240 million calls made to 9-1-1 in the U.S. each year. In addition to the stress of the unknown and what to expect at the scene of the call, emergency medical providers must deal with manual handling issues. Equipment carried is heavy, often damaged due to use in unpredictable conditions and has limited data connectivity โ€“ inhibiting the ability for on-scene support. In an effort to address these challenges, both elements of the Philips remote monitoring and defibrillator (Tempus ALS) solution are designed with a small, rugged exterior and long-lasting battery to allow emergency medical providers to focus on caring for the patient without the hassle or distraction of bulky equipment.

Earlier this year, Philips launched its new emergency care informatics suite in the U.S. market, previously in use in Europe, helping care teams spot life-threatening conditions remotely, improve accuracy of support from on-scene crews, and enhance tailoring of in-hospital care based on pre-hospital physiology. In October 2019, Philips announced a first-of-its-kind collaboration with Air Ambulance Kent Surrey Sussex (AAKSS) where helicopter Emergency Service (HEMS) teams were able to live stream patient medical information from the scene to the hospital through the Philips pre-hospital solution. Philips offers a wide range of emergency care offerings, including automated external defibrillators (AEDs), advanced life support monitors, and more. Visit Philips Emergency Care and Resuscitation for more information on the remote monitoring and defibrillator solution and Philips broad portfolio of Emergency Care solutions.

About Royal Philips

Royal Philips is a leading health technology company focused on improving people’s health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2019 sales of EUR 19.5 billion and employs approximately 81,000 employees with sales and services in more than 100 countries.

Siemens Healthineers to acquire Varian to advance fight against cancer and strengthen its position in healthcare

Siemens Healthineers to acquire Varian to advance fight against cancer and strengthen its position in healthcare

Siemens Healthineers AG and Varian Medical Systems, Inc. announced that they have entered into an agreement, pursuant to which Siemens Healthineers shall acquire all shares of Varian for USD 177.50 per share in cash. This corresponds to a purchase price of approximately USD 16.4 billion.

Varianโ€™s Board of Directors unanimously approved the agreement and recommends to the Varian shareholders also to approve the agreement. The acquisition of Varian is expected to close in the first half of calendar year 2021, with closing being subject to approval by Varian shareholders, receipt of regulatory approvals and satisfaction of other customary closing conditions.

โ€œWith this combination of two leading companies we make two leaps in one step: A leap in the fight against cancer and a leap in our overall impact on healthcare. This decisive moment in the history of our companies means more hope and less uncertainty for patients, an even stronger partner for our customers, and for society more effective and efficient medical care. Together with Varian’s outstanding and passionate employees, we will shape the future of healthcare more than ever before,โ€ said Dr. Bernd Montag, CEO of Siemens Healthineers AG.

โ€œVarianโ€™s innovative and patient centric culture has enabled us to become an iconic leader in radiotherapy and multi-disciplinary cancer care, with a trusted global brand and strong customer loyalty,โ€ said Dow Wilson, President and Chief Executive Officer of Varian. โ€œSiemens Healthineers values our talented and engaged employees and recognizes the strength of the Varian brand, our cutting-edge portfolio, and the relationships weโ€™ve nurtured. We are thrilled to partner with Siemens Healthineers to extend our renowned customer care, serving clinicians and patients from the very first stage in the fight against cancer. With Siemens Healthineers, we will transform care for a greater number of patients worldwide, as well as broaden opportunities for our employees as part of a larger and more global organization. That is why our Board is confident that combining with Siemens Healthineers is the right path forward for Varian โ€“ delivering immediate and compelling value to our shareholders, while bringing us even closer to our transformative vision of a world without fear of cancer.โ€

โ€œWith the acquisition of Varian, Siemens Healthineers is entering another attractive growth market that offers the company significant potential for value creation and aligns perfectly with the upgrading phase of Siemens Healthineersโ€™ strategy. Siemens Healthineers is creating an unprecedented, highly integrated portfolio for the global fight against cancer,โ€ said Prof. Dr. Ralf P. Thomas, Chairman of the Supervisory Board of Siemens Healthineers AG.

A HOLISTIC PARTNER FOR CANCER CARE

Varian is a world leader in the field of cancer care, with innovative solutions especially in radiation oncology and related software. In fiscal year 2019, the company generated revenues of USD 3.2 billion with an adjusted operating margin of approximately 17 percent. Varian is headquartered in Palo Alto, California, USA, and currently employs approximately 10,000 people worldwide. With a holistic approach to cancer care, the company is increasingly leveraging technologies such as artificial intelligence, machine learning and data analysis to further improve cancer treatment and expand access to care.

The International Agency for Research on Cancer2 expects the prevalence of cancer to almost double between 2010 and 2030, with more than 50 percent of all cancer patients undergoing radiotherapy. At the same time, significant growth in therapeutic innovations is driving demand for personalized diagnosis and therapy planning, implementation and monitoring.

Varianโ€™s decades of progress in developing and delivering multidisciplinary, integrated cancer care has kept the company at the forefront of innovation for more than 70 years. Varian thus offers an ideal fit to Siemens Healthineers leading businesses in medical imaging, laboratory diagnostics and interventional procedures.

BUILDS ON A LONG AND SUCCESSFUL PARTNERSHIP

Since 2012, Siemens Healthineers and Varian have been working together successfully in the strategic โ€œEnVisionโ€ partnership to shape the future of cancer treatment, combining Varianโ€™s innovative therapeutic systems and Siemens Healthineers leading imaging technology. This transaction builds on this long-standing partnership to develop improved cancer therapy solutions โ€“ from imaging for treatment planning to focused radiation therapy โ€“ for efficient workflow and effective, personalized treatment.

TRANSACTION TERMS

Varian is expected to positively contribute to Siemens Healthineers adjusted basic EPS3 within the first 12 months after closing of the acquisition. Following the closing of the acquisition, Siemens Healthineers aims for EBIT synergies of at least EUR 300 million per annum in fiscal year 2025.

Siemens Healthineers plans to finance the acquisition of Varian with a mix of debt and equity. Siemens Finance B.V., a subsidiary of Siemens Aktiengesellschaft, will provide Siemens Healthineers for a transitional period with a bridge facility in an amount of EUR 15.2 billion to finance the acquisition price and additional costs and expenses in connection with the acquisition of Varian.

Siemens Healthineers plans to replace up to approximately 50 percent of the amount available under the bridge facility granted by Siemens Finance B.V. through the issuance of equity. For this purpose, Siemens Healthineers intends to increase the share capital by issuing new shares with subscription rights expected to be excluded. In a first step, Siemens Healthineers plans to place new shares without a prospectus, depending on market conditions, still within calendar year 2020. The issuance of new shares will raise the free float and presumably the trading volumes of Siemens Healthineers shares. It is planned that the remaining amounts under the bridge facility will be refinanced through debt provided by Siemens AG or one of its subsidiaries to Siemens Healthineers. Such debt will be raised externally by Siemens AG and then be passed on to Siemens Healthineers through loans at market conditions. After closing, Varian will continue to operate under the Varian name, as a Siemens Healthineers brand.

BioTelemetry acquires remote patient monitoring platform from Centene subsidiary

BioTelemetry acquires remote patient monitoring platform from Centene subsidiary

BioTelemetry, the leading remote medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care, announced it has acquired the On.Demand remote patient monitoring (RPM) and coaching platform, operated by Envolve People Care, Inc., a Centene Corporation subsidiary.

This acquisition adds chronic RPM and coaching solutions to BioTelemetryโ€™s current suite of acute care connected health products and services, focusing specifically on diabetes, hypertension and chronic heart failure.

As part of this acquisition, and under the companiesโ€™ strategic partnership agreement, BioTelemetry becomes the exclusive provider of diabetes RPM services to Centene Medicaid members currently utilizing, implementing or engaged to implement the platform in 2020.

In addition to Centene, BioTelemetry will partner externally with payor, provider and employer organizations to improve health outcomes, reduce costs and eliminate waste using On.Demandโ€™s targeted monitoring and coaching interventions.

โ€œWe are excited to add On.Demand to our connected health portfolio,โ€ said Joseph H. Capper, President and CEO of BioTelemetry.

โ€œThis acquisition uniquely positions BioTelemetry to deliver population health solutions at a time when remote and telehealth options are increasingly important in improving effectiveness across the healthcare continuum. We are delighted to partner with an organization like Centene, which has demonstrated a clear commitment to improving the lives of so many people and communities.โ€

On.Demand is a mHealth solution that combines real-time monitoring of biometric data with cellular- and web-based technology, proactive and reactive health coaching, population health reporting and customizable interventions. The platform is designed to supplement a physicianโ€™s care plan by increasing patient engagement, improving compliance and reducing costs.

It matches people to the clinical expertise and condition management tools they need when they need them, providing intervention and triage that helps bridge the gap between patient visits. In addition, the platform also includes Alexa Skill. On.Demand users are able to schedule coaching appointments, access educational resources, set reminders, and receive real-time assessments and immediate referrals for mental and physical health needs.

BioTelemetry is the pioneer in patient care monitoring, providing technology and services that enable healthcare providers to monitor and diagnose patients and clinical research subjects more efficiently, accurately and cost-effectively. Through its connected health solutions, population health management platform and support of some of the largest clinical trials, BioTelemetry is advancing health and improving lives. BioTelemetryโ€™s suite of services and devices expand across cardiac outpatient telemetry, diabetes, hypertension and weight management.

GLC + GLCM Announce Rapid Detection COVID-19 Test – Results in Seconds

Asia Pacific countries fast track review processes benefits Clinical Trial clients

Graphene Leaders Canada (GLC) Inc. together with subsidiary GLC Medical (GLCM) Inc. announce their development of a graphene-enhanced sensor for use in their COVID-19 Rapid Test delivering accurate and reliable results in seconds. This graphene-enhanced sensor supports the fastest and easiest to use Rapid COVID-19 Virus Detection Test Kit and is the only of its kind saliva test, eliminating the nasopharyngeal swab, all certified practitioner oversight requirements, does not require expensive equipment, and there is no cross handling which increases cross contaminations. GLCMโ€™s test directly detects the virus ensuring no false positive/negative results, unlike other tests which detect only the byproducts of infection and are therefore unreliable.

GLCM is pleased to report it has completed development of the graphene-enhanced sensor used in the rapid test kit, which is an in-vitro diagnostic device which produces a signal when exposed to COVID-19 viral antigens. With the achievement of the positive identification of the viral antigens, GLCM has commenced development of a functional prototype of the rapid-response test. GLCM expects to benefit from expedited regulatory and clinical-testing requirements as announced by several regulatory agencies including Health Canada and the United Statesโ€™ FDA.

GLCMโ€™s COVID-19 point-of-care test will offer a unique advantage over other tests as it detects the presence of the COVID-19 virus. To date, other competitive tests that have been announced are predominately nucleic acid tests and serological assay tests. The serological assay tests are designed to identify IgM and IgG antibodies present post infection. Nucleic acid tests identify active infection, however, still require the use of the nasopharyngeal swab and results must be interpreted by a certified practitioner using expensive equipment which is a slow-moving process. Both the serological and the nucleic tests produce false positive and false negative results, whereas GLCMโ€™s test has been developed to indicate a positive result only when the COVID-19 virus is present, allowing for direct and clear interpretation by the user.

Jason Deacon, Product Development Lead of GLC-GLCM indicated, โ€œGraphene is the ideal sensing material. The 2D nature and conductive attributes of graphene make for an extremely sensitive material to detect any molecule. I have investigated this principle extensively during my time at Cambridge University. At GLC-GLCM, we have made the surface highly specific to SARS-CoV-2 (COVID-19) to ensure that our rapid test will save lives. The study of 2D materials has been encased in academia for 15 years. Our team at GLC-GLCM believes that nanotechnology regarding 2D materials is critical to future technology and innovation, with graphene at the forefrontโ€.

GLCMโ€™s rapid test is an โ€œat the doorโ€ technology which is perfect before boarding a plane, entering a venue for a concert or sporting event, as it delivers instant results regaining confidences to bring us back to our โ€œnormalโ€ before the pandemic.

The Company is advancing discussions with manufacturers and governments in several countries in order to facilitate production protocols reflective of their countryโ€™s government regulatory compliance requirements.

Donna Mandau, President & CEO for GLC-GLCM said, โ€œThe success of this development offers the world a solution for COVID-19, and as our graphene is tailorable, we can offer a fast solution to future virusโ€™ in rapid modification of our graphene which will ensure we do not relive the major economic shutdown as experienced with COVID-19. The inspiration for all of us at GLC-GLCM is to offer our graphene solutions for People and Planet. This rapid test brings family and friends together for times of joy free from fear of COVID-19. This test also brings family together in those times that we need to say good-bye to a loved one. No one should have to die alone again.โ€
About Graphene Leaders Canada (GLC) Inc.

Graphene Leaders Canada (GLC) Inc. is a Canadian technology company producing high quality, high purity graphene nanomaterials which functions as a platform technology with the ability to add value across numerous applications. Graphene Leaders Canada Inc. is focused to work with industry to develop solutions by integrating the graphene to develop new innovative products. GLCโ€™s tag line is โ€œMaking Great Products Even Greaterโ€.

GLC Medical (GLCM) Inc. is a subsidiary of GLC Inc. and offers graphene solutions in the medical industry leveraging our material science expertise in working with high quality graphene and developing products and solutions to serve the betterment of People and Planet. GLCMโ€™s tag line is โ€œHealth Through Technologyโ€.

Qualigen Therapeutics Begins Shipping FastPack COVID-19 Antibody Test

Qualigen Therapeutics Begins Shipping FastPack COVID-19 Antibody Test

Qualigen Therapeutics, Inc. announced it has begun commercial shipments of its FastPackยฎ SARS-CoV-2 IgG diagnostic test for COVID-19 antibodies. This test has been submitted to the U.S. FDA for Emergency Use Authorization (EUA), and earlier this month the Company submitted an official notification to the FDA of its plans to exercise its right to commence sales while the EUA is pending.

The FastPack COVID-19 antibody test is a chemiluminescent microparticle test intended for the qualitative detection (i.e., yes/no) of SARS-CoV-2 IgG antibodies in blood to identify individuals with an adaptive immune response to the virus that causes COVID-19, indicating recent or prior infection of the disease. Prior infection is presumed to be indicative of immunity against re-infection for at least some period of time.

The COVID-19 antibody test is designed for use with Qualigen’s new FastPack PRO System, a point-of-care diagnostic instrument. The FastPack PRO System is an upgraded version of Qualigen’s flagship FastPack IP rapid immunoassay diagnostic system โ€“ in essence, a “lab in a box” that allows test results to be delivered with the accuracy of large laboratories but much more rapidly. Unlike tests at reference laboratories, the FastPack tests are conducted in physician offices, clinics and hospitals, and provide results in approximately 10 minutes. The Company announced earlier this month that a portion of the proceeds from its recent funding will be used to increase production of the FastPack PRO System.

“We are pleased to start shipping our FastPack PRO systems and serology tests for COVID-19 antibodies, and expect to see a ramp-up of production through the end of the year,” stated Michael Poirier, President, Chief Executive Officer and Chairman of Qualigen. “Testing for SARS-CoV-2 IgG antibodies is likely to be critical to fighting this disease for years to come, not only in this early stage of tracking and tracing, but also in time to prioritize vaccine deployment. We believe our rapid diagnostics offering provides accurate results for clinicians to have more timely and actionable information than other testing approaches can provide.”

Qualigen has been producing high-quality diagnostic testing products for nearly 20 years, and has established a strong reputation for delivering highly accurate point-of-care tests that help save people’s lives.

About the FastPack System
The FastPack System is a rapid and highly accurate immunoassay diagnostic testing system consisting of a FastPack analyzer and a FastPack test pouch (a single-use, disposable foil packet that includes the FastPack reagent chemistry). Installed in physician offices, clinics and small hospitals around the world, the system quickly detects diseases and medical conditions at the point-of-care. Since the conception of the system, the Company has expanded its assay menu to 10 tests including tests for prostate cancer, thyroid function, metabolic disorders, antibodies against SARS-CoV-2 and research applications. Over the past 20 years, FastPack has generated more than $100 million in commercial sales. Qualigen’s worldwide distributor for FastPack is Sekisui Diagnostics, LLC, a subsidiary of a multibillion-dollar Japanese chemical and technology company; Sekisui, in turn, works with national distributors including McKesson Corporation and Henry Schein Inc.

About Qualigen Therapeutics, Inc.
Qualigen Therapeutics, Inc. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack System, which has been used successfully in diagnostics for almost 20 years. The Company’s cancer therapeutics pipeline includes ALAN (AS1411-GNP), RAS-F and STARSโ„ข. ALAN (AS1411-GNP) is a DNA coated gold nanoparticle cancer drug candidate that has the potential to target various types of cancer with minimal side effects. The foundational aptamer of ALAN, AS1411, is also being studied for use in treating viral-based infectious diseases, including COVID-19. RAS-F is a family of RAS oncogene protein-protein interaction inhibitor small molecules for preventing mutated RAS genes’ proteins from binding to their effector proteins; preventing this binding could stop tumor growth, especially in pancreatic, colorectal and lung cancers. STARSโ„ข is a DNA/RNA-based treatment device candidate for removal from circulating blood of precisely targeted tumor-produced and viral compounds. The FastPack System menu includes point-of-care diagnostic tests for cancer, men’s health, hormone function, vitamin D status and antibodies against SARS-CoV-2. Qualigen’s facility in Carlsbad, California is FDA and ISO Certified and its FastPack product line is sold worldwide by its commercial partner Sekisui Diagnostics, LLC.

Luciole Medical AG and Adolphe de Rothschild Research Collaboration in Brain Oxygenation Monitoring

Luciole Medical AG and Hospital Fondation Adolphe de Rothschild Enter Research Collaboration in Brain Oxygenation Monitoring

Luciole Medical AG, a Swiss medical technology company, and Hรดpital Fondation Adolphe de Rothschild announce a collaboration in brain metabolism monitoring research. The two organizations are active in the area of brain hemodynamic and oxygenation monitoring.

โ€œLuciole Medicalโ€™s next-generation devices address an area of immense medical need. They enable clinicians to monitor a patientโ€™s brain function in real time and make informed, quick decisions that can be vital for their survival,โ€ added Dr. Nicolas Engrand, deputy head of the Intensive Care Department at Hรดpital Fondation Adolphe de Rothschild. โ€œI am impressed with what Luciole Medical team has achieved thus far and am looking forward to working together with Lucioleโ€™s scientists.โ€

Luciole Medical has developed a technology platform that measures brain oxygenation parameters and cerebral blood flow, critical elements necessary for proper brain function, based on the absorbance and transmittance properties of near-infrared light. Luciole Medical is the only company offering a comprehensive oxygenation and hemodynamic solution for intensive care and anesthesiology. Both products have received market authorization in Europe and the company has started the regulatory process in the USA.

โ€œWorking together with such a prestigious clinical organization as Hรดpital Fondation Rothschild is an honor and a strong recognition of our achievements. It represents an important step in Luciole Medicalโ€™s strategy to establish the company as the leading developer of innovative solutions to monitor and evaluate brain function in patients,โ€ commented Dr. Philippe Dro, CEO of Luciole Medical. โ€œWe are looking forward to joining forces with the team of Dr. Engrand to progress in the understanding of cerebrovascular pathologies.โ€

About Luciole Medical

Luciole Medical AG is developing a unique next-generation platform of brain monitoring sensors to rapidly provide important information allowing the proper diagnostic and monitoring of compromised oxygen supply conditions and complications. The platform also uses a proprietary complex algorithm to analyze large data sets and extract clinically relevant information. The company obtained the CE mark for a minimally invasive probe for ICUs (RheoProbe) and a new generation patch for external measurement of brain oxygenation parameters (RheoPatch). The Swiss-based private company is a spin-off from the Swiss Federal Institute of Technology and the University of Zurich. For more information, visit www.luciolemedical.ch

About Hรดpital Fondation Adolphe de Rothschild

Hรดpital Fondation Adolphe de Rothschild is a university hospital founded in 1905 that is regularly listed among the best French hospitals and is equipped with state of the art medical equipment and supported by internationally renowned experts. It specializes in pathologies of head and neck area, offering 24/7 emergency treatment and scheduled treatment for both children and adults. The hospital is a private nonprofit organization (ESPIC) with more than 400,000 consultations and medical acts and 30,000 admissions per year. Each year, the hospital is actively involved in more than 150 clinical trials, publishes more than 300 scientific papers and trains approximately 700 students.

GE Healthcare to Distribute Osprey Medical’s Technology to Address Angiography Based Acute Kidney Injury

GE Healthcare to Distribute Osprey Medical's Technology to Address Angiography Based Acute Kidney Injury

GE Healthcare and Osprey Medical Inc. announced a strategic alliance under which GE Healthcare will exclusively distribute Ospreyโ€™s product portfolio in Europe, Russia, Middle East, Africa, Central Asia and Turkey. Ospreyโ€™s DyeVertโ„ข contrast minimization devices, complemented by GE Healthcare’s range of iodinated x-ray contrast media, offer healthcare professionals a technology platform to address the rising problem of Acute Kidney Injury (AKI) following interventional coronary angiograms in patients with Chronic Kidney Disease (CKD).

Ospreyโ€™s President and CEO, Mike McCormick, stated: โ€œWe are pleased to be partnering with GE Healthcare to commercialize our products in global markets to address the rising problem of AKI following heart imaging procedures in patients with poor kidney function.โ€

โ€œGE Healthcare and Osprey share a similar goal rooted in improving patient outcomesโ€ added Kevin Oโ€™Neill, President and CEO of GE Healthcareโ€™s Pharmaceutical Diagnostics business. โ€œBoth our product portfolios and educational efforts, which are aligned with cardiology guidelines for AKI minimization, offer interventional cardiologists the opportunity to safely image patients by reducing the risk of AKI,โ€ concluded Oโ€™Neill.

AKI is sudden damage to the kidneys that causes them to not work properly. It can range from minor loss of kidney function to complete kidney failure.1 With one out of four angiography patients presenting with CKD,2 the risk for these patients to develop AKI is a serious concern for catherization labs and hospitals. Patients with impaired kidneys are at a significantly increased risk for negative outcomes and for longer hospital stays.3 The European Society of Cardiology and European Association for Cardio-Thoracic Surgery have issued joint guidelines for the reduction of AKI.4 These guidelines recommend that physicians should screen patients for risk of AKI, ensure they are properly hydrated, consider patient appropriate contrast choice and minimize the contrast volume delivered to the patient. Osprey and GE Healthcareโ€™s portfolios are aligned with these guidelines so that healthcare professionals can help minimize AKI complications in patients with CKD.

Under the four-year agreement, GE Healthcare will commercialize Ospreyโ€™s DyeVert portfolio which reduces the amount of contrast that reaches the kidney (40% average reduction) with no compromise in image quality. Ospreyโ€™s technology is the only FDA cleared medical device that is indicated for reducing patient contrast exposure. The DyeVert portfolio allows healthcare providers to monitor cumulative dye dose specific to each patientโ€™s kidney function determined prior to the procedure.

GE Healthcareโ€™s Pharmaceutical Diagnostics unit develops and supplies imaging agents used to support approximately 90 million procedures per year globally, equivalent to three patients every second. Its range of products include iodinated X-ray contrast media used in interventional and other diagnostic procedures including coronary angiography.

The four (4) year exclusive distribution agreement enables GE Healthcare to commercialize Ospreyโ€™s products within the Region. During the term of this agreement necessary commercial terms have been discussed and agreed. As Osprey develops new products GE Healthcare will be granted a right of first refusal to distribute and promote these products in the Region.

About Osprey Medical Inc

Osprey Medicalโ€™s vision is to make heart imaging procedures safer for patients with poor kidney function. The amount of dye (contrast) used during angiographic imaging procedures increases the patient’s risk for dye-related kidney damage known as contrast-induced acute kidney injury (CI-AKI). The Companyโ€™s core technologies originated from research conducted by Dr David Kaye at Melbourneโ€™s Baker Institute. Its proprietary dye reduction and monitoring technologies are designed to help physicians minimize dye usage and monitor the dose of dye in real time throughout the procedure. The Companyโ€™s DyeVertโ„ข Plus System reduces contrast while maintaining image quality in a self-adjusting, easy-to-use design that monitors dye usage. Osprey Medicalโ€™s Board and Management are composed of experienced and successful personnel with established track records covering medical device development, regulatory approvals, sales and marketing, and mergers/acquisitions. Osprey Medicalโ€™s advisory board comprises world-recognized experts in heart and kidney diseases.

About GE Healthcare:

GE Healthcare is the $16.7 billion healthcare business of GE. As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world.

Olympus Launches New EBUS-TBNA Needle for Lung Cancer Staging and Diagnosis

Olympus Launches New EBUS-TBNA Needle for Lung Cancer Staging and Diagnosis

Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, has announced the launch of the ViziShot 2 25 G needle for Endobronchial Ultrasound Transbronchial Aspiration (EBUS-TBNA). This device is a part of the Olympus EBUS Solution which offers a comprehensive solution for diagnosing and staging lung cancer. The Olympus EBUS system is the only solution recommended for both lymph node sampling and peripheral lesion detection.

โ€œAs the only company manufacturing and selling both bronchoscopes and needles, Olympus is proud to expand our EBUS-TBNA product family portfolio with the 25 G EBUS-TBNA needle. Our comprehensive pulmonary solutions bring great value to our physician customers striving to advance diagnosis and staging capabilities for lung disease and lung cancer,โ€ said Lynn Ray, Vice President, General Manager, Global Respiratory, Olympus.

EBUS-TBNA, a procedure used in the diagnosis and staging of lung cancer, allows physicians to visualize diseased tissue, lymph nodes or lesions beyond the walls of the airways. Samples from parts of the lymph node that require further investigation can be taken using a specialized aspiration needle.

The ViziShot 2 25 G, is the smallest gauge size of the Olympus EBUS-TBNA needle portfolio. Benefits of the smaller lumen and enhanced design features of the 25 G needle include:

High Quality Samples: Even with a smaller lumen, the needle is able to obtain sufficient quantities of high-quality specimen needed for establishing a diagnosis and reliable staging.
Increased Accessibility during EBUS-TBNA: The small diameter of the 25 G EBUS-TBNA needle enhances scope angulation leading to increased accessibility, and flexibility and of difficult-to-reach lymph nodes.
Improved Puncture Capabilities: This needle requires less puncture force to the sample due to the curved edge back-cut needle tip design feature.
Clear Target Visualization: Clear ultrasound echogenicity is maintained due to the dimpled needle design.

โ€œA 25-gauge needle is something I have always wanted available in our lab,โ€ said Ramyar Madhavi, MD of Keck School of Medicine of the University of Southern California. โ€œFrom our point of view, the needle tip is sharper; it handles easily and provides a more than adequately sized, high-quality specimen. Having this needle allows me to feel more comfortable when proceeding with EBUS on patients for whom discontinuing anticoagulant therapy is not an option.โ€

Among both men and women, lung cancer is the leading cause of cancer-related deaths in the U.S., according to the Centers for Disease Control and the American Cancer Society. It is estimated that over 370 Americans will die each day from the disease in 2020.1 Since the announcement of new lung cancer screening recommendations for high-risk patients by the U.S. Preventive Services Task Force in July 2013, we have seen a 5 percent decline in lung-cancer related deaths2, lending evidence to the effectiveness of early diagnosis and accurate staging of lung cancer.

About Olympus Medical Systems Group
Olympus is a global technology leader, crafting innovative optical and digital solutions in medical technologies; life sciences; industrial solutions; and cameras and audio products. Throughout our 100-year history, Olympus has focused on being true to society and making peopleโ€™s lives healthier, safer and more fulfilling.

Our Medical Business works with health care professionals to combine our innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing with their skills to deliver diagnostic, therapeutic and minimally invasive procedures to improve clinical outcomes, reduce overall costs and enhance quality of life for patients.

Drug diversion and compliance experts join ANiGENTโ€™s Board of Advisors

Drug diversion and compliance experts join ANiGENTโ€™s Board of Advisors

Three drug diversion prevention influencers โ€” Pamela Mergens, M.D.; Simone Cummings, M.H.A., Ph.D.; and global life sciences executive Neal Long โ€” have recently joined ANiGENTโ€™s Board of Advisors (BOA). They will provide insights that will help the company identify and fine tune the future drivers of growth to accelerate ANiGENTโ€™s success.

ANiGENT is the first and only software provider to deliver a comprehensive solution that

helps facilities track and monitor potential drug diversion among all users and all drugs in all locations. Its proprietary drug prevention software is the result of a collaboration with Mayo Clinic.

โ€œWeโ€™re pleased to welcome these remarkable individuals to our board,โ€ said V.C. Jun Fabella, Jr., chief executive officer and managing partner of ANiGENT. โ€œTheir participation comes at an exciting time as we drive our business strategy forward to fulfill our purpose of helping organizations keep patients safe.โ€

Dr. Mergens, Dr. Cummings, and Long all present unique expertise that will serve ANiGENT well. Dr. Mergens is an anesthesiologist who is affiliated with the Mayo Clinic in Phoenix, Az. She is currently involved in drug diversion prevention as chair of the healthcare facilityโ€™s committee and the director of the anesthesiology program. She has also partaken in many drug diversion cases and presented at conferences and meetings.

Dr. Cummings is dean of the Walker School of Business and Technology at Webster University, St. Louis. A proven leader, she has conducted multiple studies focusing on the impact of drug diversion among healthcare professionals. She is also a board member of the St. Louis Regional Health Commission.

Neal Long is the founder and chief executive officer (CEO) of ConsortiEX, a highly innovative Healthcare IT software and services company aimed at health system pharmacy compounding and supply chain. A business transformation expert, Long has spent the past 12 years guiding startup companies to be success driven. He also has experience working with industry giants, such as GE, Marquette and Phillips.

โ€œPlans are in place to expand the BOA membership as ANiGENT continues its growth trajectory,โ€ noted Fabella. โ€œIn the meantime, these individuals will be invaluable in broadening ANiGENTโ€™s horizons. Their insights will lead to new thinking related to key business and technology domains.โ€

ANiGENT is the only company that delivers a comprehensive software solution that can track and monitor all users and drugs at any location to prevent occurrences of drug diversion. The patent-pending software is based on the Medication Administration & Analysis Program (MAAP), a solution that Mayo Clinic has used at its own facilities. MAAP will leverage machine-learning algorithms to:

โ€ข Continually capture and analyze data
โ€ข Rapidly identify and prevent drug diversion
โ€ข Pinpoint areas that need process improvement

ABOUT ANiGENT

ANiGENT, the result of a collaborative partnership with the Mayo Clinic, is a new company that delivers a comprehensive, patent-pending solution based on Medication Administration & Analysis Program (MAAP). Created by chief product officer and managing partner Charles Dโ€™Amato, MAAP Analytics uses machine learning to deliver a state-of-the-art drug diversion surveillance system.

Recordati: Results From the Phase III LINC-3 Study Of ISTURISA for the Treatment of Cushing’s Disease Published in Lancet Diabetes & Endocrinology

Recordati: Results From the Phase III LINC-3 Study Of ISTURISA

Recordati Rare Diseases Inc. announces that Lancet Diabetes & Endocrinology has published results from the Phase III LINC-3 pivotal study of ISTURISA, recently approved for the treatment of Cushingโ€™s disease in adults. Patients with Cushingโ€™s disease have an increased risk of significant comorbidities, including cardiovascular and cerebrovascular diseases as a result of excessive cortisol levels.1 Data from the large LINC-3 study, which enrolled 137 patients with Cushingโ€™s disease, demonstrate that ISTURISA rapidly reduces mUFC and sustains this reduction alongside improvements in comorbidities, clinical signs and patientsโ€™ quality of life over 48 weeks.

โ€œThe exciting data, published today, underscore the efficacy and safety of ISTURISA in a prospective setting, and represent a significant advance for the management of patients with Cushingโ€™s disease, a serious and potentially life-threatening rare condition,โ€ said Rosario Pivonello, MD, Professor of Endocrinology at the Federico II University of Naples, Italy. โ€œI would like to thank all the patients who participated in the LINC-3 study, and their families, who have helped to bring this new and welcome treatment option to this underserved patient population.โ€

The LINC-3 study met its primary endpoint, with significantly more patients maintaining normal mUFC with ISTURISA without a dose increase than placebo (86% vs 29%; P<0.0001) following 8 weeks of randomized withdrawal (week 34). Further analysis of patientsโ€™ mUFC response found:

  • Over half (53%) of patients achieved the key secondary endpoint of a normal mUFC after an initial 24 weeks of open-label treatment with ISTURISA, without any dose increase after week 12
  • Most (72%) patients had normal mUFC at week 12
  • Two-thirds (66%) of patients had normal mUFC at the end of the 48-week study
  • Almost all (96%) patients achieved normal mUFC at some point during the study, with a median time to first complete response of 41 days

Decreases in mUFC levels during treatment with ISTURISA were accompanied by improvements in clinical signs and cardiovascular-related risk factors (weight, BMI, blood glucose, blood pressure, and total cholesterol). ISTURISA is well tolerated, with the most common adverse effects in LINC-3 being nausea (42%), headache (34%), fatigue (28%) and adrenal insufficiency (28%).

โ€œThe publication of these data in Lancet Diabetes & Endocrinology confirms ISTURISA as an effective new treatment option for patients with Cushingโ€™s syndrome,โ€ said Andrea Recordati, CEO. โ€œFollowing the recent approval of ISTURISA in the US and EU, we are excited to bring ISTURISA to all of those patients who need it.โ€

About Recordati Rare Diseases Inc.
Recordati Rare Diseases Inc. is a biopharmaceutical company committed to providing often-overlooked orphan therapies to the underserved rare disease communities of the United States. Recordati Rare Diseases is a part of the Recordati Group, a public international specialty pharmaceutical company committed to the research and development of new specialties with a focus on treatments for rare diseases.

Recordati Rare Diseasesโ€™ mission is to reduce the impact of extremely rare and devastating diseases by providing urgently needed therapies. We work side-by-side with rare disease communities to increase awareness, improve diagnosis and expand availability of treatments for people with rare diseases. The companyโ€™s U.S. corporate headquarters is located in Lebanon, NJ, with global headquarter offices located in Milan, Italy.

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