New eHealth Digital Service Infrastructure allows first EU citizens to use ePrescriptions across borders and more EU news briefs

Healthcare IT News | January 29, 2019

New initiative sees EU citizens use ePrescriptions in other EU country. Finnish patients can now get their medicines from pharmacies in Estonia prescribed electronically by their doctors back in Finland through the new eHealth Digital Service Infrastructure, the European Commission announced last week. This applies to pharmacies in Estonia participating in the initiative and all Finnish ePrescriptions. “People should be able to use their e-prescriptions across borders. Free movement is a founding principle of the EU: we must make it as easy as possible for people to get treatment or medicines when abroad in the EU,” said Andrus Ansip, Digital Single Market vice president. "The next major step will be to simplify patient access to their very own health data, by developing a common format for exchanging electronic health records between EU countries."

Spotlight

To market a medical device in the EU, a manufacturer must demonstrate that the device is safe, that it performs as intended, and that the risks associated with the use of the device are acceptable when weighed against the benefits to patients. Clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device to verify its clinical safety and performance. It may be based on a literature review and/or clinical experience and/or clinical investigations...


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HEALTH TECHNOLOGY

HCL Technologies and NEORIS Sign Agreement for Integrated IT Services

HCL Technologies | March 23, 2022

HCL Technologies a leading global technology company, has signed a collaboration agreement with NEORIS, a leading global digital accelerator that co-creates disruptive solutions for digitally aspirational companies. The agreement will bring unique capabilities to clients in global markets, including the ability to increase application usage time, business management operations and integrated IT services. As a result of this collaboration, both companies will be able to expand their operations and access new markets, making them better positioned to explore global markets. NEORIS, with more than 20 years of experience and global presence including operations in Latin America, will strengthen HCL’s presence in territories like Mexico and South America which offer great opportunities for commercial development. With operations in 52 countries, HCL Technologies will aid NEORIS in expanding its business internationally, primarily in the United States, Europe and Asia. Together, NEORIS and HCL Technologies can speed up digital transformation, mitigate risks, empower teams based on product development, create a zero-incident culture and save costs. The solutions that NEORIS and HCL will offer together will focus on complementing approaches and solutions, new technologies and talent development among other areas of expertise. "HCL Technologies and NEORIS will work together to find new business opportunities in a united effort, one where NEORIS will provide the best talent with the best skills in the market to reduce costs, time and risk. We have positioned our centers of excellence to scale and meet the expectations of each business and deliver value. Our partnership enables us to provide the best services and solutions to our clients while positioning them for future success." Marcelo Costa, global head of strategic alliances at NEORIS "We are delighted to offer this unique program to our clients in Latin America who are seeking ways to optimize their teams through best-in-class technology solutions," said Ajay Bahl, corporate vice president, HCL Technologies. "Our collaboration will also contribute to our continuous effort to build a great talent pool in Mexico to deliver industry-best service and capabilities to our customers." About NEORIS NEORIS is a leading global digital accelerator that co-creates disruptive solutions for companies that digitally aspire to increase their connections with customers, employees and stakeholders. The company is made of creative teams with technical experience and deep knowledge of their sectors. Headquartered in Miami, Florida, NEORIS has a network of global delivery centers, design studios, and operations in the United States, Europe, Latin America and India. More information is available at www.NEORIS.com, LinkedIn, and Twitter. About HCL Technologies HCL Technologies (HCL) empowers global enterprises with technology for the next decade, today. HCL’s Mode 1-2-3 strategy, based on its deep-domain industry expertise, customer-centricity and entrepreneurial culture of Ideapreneurship™, enables businesses to transform into next-gen enterprises. HCL offers its services and products through three business units: IT and Business Services (ITBS), Engineering and R&D Services (ERS) and Products & Platforms (P&P). ITBS enables global enterprises to transform their businesses through offerings in the areas of applications, infrastructure, digital process operations and next generational digital transformation solutions. ERS offers engineering services and solutions in all aspects of product development and platform engineering HCL Technologies (HCL) empowers global enterprises with technology for the next decade, today. HCL’s Mode 1-2-3 strategy, based on its deep-domain industry expertise, customer-centricity and entrepreneurial culture of Ideapreneurship™, enables businesses to transform into next-gen enterprises. HCL offers its services and products through three business units: IT and Business Services (ITBS), Engineering and R&D Services (ERS) and Products & Platforms (P&P). ITBS enables global enterprises to transform their businesses through offerings in the areas of applications, infrastructure, digital process operations and next generational digital transformation solutions. ERS offers engineering services and solutions in all aspects of product development and platform engineering

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HEALTH TECHNOLOGY

Stryker, One of the World’s Leading Medical Technology Companies, announces definitive agreement to acquire Vocera Communications

Stryker | January 07, 2022

Strykerannounced today a definitive merger agreement to acquire all of the issued and outstanding shares of common stock of Vocera Communications, Inc.for $79.25 per share, or a total equity value of approximately $2.97 billion and a total enterprise value of approximately $3.09 billion (including convertible notes). Vocera, which was founded in 2000, has emerged as a leading platform in the digital care coordination and communication category. The importance of this growing segment has continued to expand throughout the pandemic as it aims to reduce cognitive overload for caregivers and enables them to deliver the best patient care possible. Vocera brings a highly complementary and innovative portfolio to Stryker’s Medical division that will address the increasing need for hospitals to connect caregivers and disparate data-generating medical devices, which will help drive efficiencies and improve safety and outcomes. Vocera’s highly developed software competency, unique and innovative hardware solutions, and the ability to securely enable remote communication between patients and their families, complements Stryker's Advanced Digital Healthcare offerings. The combined business will further advance Stryker’s focus on preventing adverse events throughout the continuum of care. “This acquisition underscores our commitment and focus on our customer. Vocera will help Stryker significantly accelerate our digital aspirations to improve the lives of caregivers and patients.” Kevin Lobo, Chair and Chief Executive Officer, Stryker “Today’s milestone represents an exciting opportunity for Vocera given the clear alignment of mission, goals and culture between our two organizations and our ability to drive even greater economic and clinical value for our customers,” said Brent Lang, Chairman and Chief Executive Officer, Vocera. Under the terms of the merger agreement, Stryker will commence a tender offer for all outstanding shares of common stock of Vocera for $79.25 per share in cash. The boards of directors of both Stryker and Vocera have unanimously approved the transaction. The closing of the transaction is subject to expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, completion of the tender offer and other customary closing conditions. The acquisition is expected to close in the first quarter of 2022 and is expected to have a neutral impact to net earnings per diluted share in 2022. About Stryker Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. About Vocera The mission of Vocera Communications, Inc. is to improve the lives of healthcare professionals, patients, and families. Founded in 2000, Vocera provides clinical communication and workflow solutions that help protect and connect team members, increase operational efficiency, enhance quality of care and safety, and humanize the healthcare experience. More than 2,300 facilities worldwide, including nearly 1,900 hospitals and healthcare facilities, have selected Vocera solutions to enable their workforce to communicate and collaborate with co-workers and engage with patients and families. Mobile workers can choose the right device for their role or task, including smartphones or one of the company’s wearable communication devices, and use voice commands to easily reach people by name, role, or group. The hands-free Vocera Smartbadge was named to TIME’s list of the 100 Best Inventions of 2020. Vocera solutions can integrate with more than 150 clinical and operational systems, including electronic health records, nurse call systems, ventilators, physiological monitors, and more. In addition to healthcare, Vocera solutions are found in aged care facilities, veterinary hospitals, schools, luxury hotels, retail stores, power facilities, and more.

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HEALTH TECHNOLOGY

Brainlab Announces the Majority Acquisition of medPhoton

Brainlab | May 13, 2022

Brainlab, a digital medical technology company, announced today the majority acquisition of medPhoton GmbH, a Salzburg, Austria-based company, that develops and manufactures robotic imaging solutions for image guided radiation therapy and surgery. Over the last years, medPhoton has maintained a close partnership with Brainlab in the field of intraoperative imaging. This collaboration resulted in the market launch of the mobile imaging robot, Loop-X®, in 2020. Brainlab strategically invested in medPhoton, co-funded the development of Loop-X and became the exclusive distributor of the mobile imaging robot in the field of surgery. "Through the completion of this majority acquisition, we want to build on the previous success of Loop-X and decisively shape the future of intraoperative imaging. In this way, we can combine and align the entrepreneurial pursuits and innovative potential of both companies. Our united goal is to expand the market position of Loop-X as a 3D imaging device for surgery so that doctors can gain access to cutting edge equipment for patient treatment." Stefan Vilsmeier, President and CEO of Brainlab Loop-X mobile imaging robot is central to the Brainlab robotics portfolio and already part of everyday clinical practice in numerous hospitals worldwide. Loop-X sets new standards in surgery with automated imaging steps and robotic assistance. With the support of Loop-X, surgeons and staff gain flexibility and freedom of movement during surgery through access to high resolution 2D and 3D imaging. The independent movement of the imaging components and collimation capabilities allow non-isocentric imaging. Structures can be covered that are much larger—for example, the pelvis—but, patient tailored imaging now also covers much smaller areas—reducing the radiation volume to where it is needed. Beyond diagnostic imaging, this intelligent robot can capture partial information, “digitizing” anatomical intraoperative changes in order to update a “digital model” of the patient previously generated by aggregating pre-operative images. Heinz Deutschmann, CEO of medPhoton, looks forward to the expansion of the strategic partnership: "From the very beginning, Brainlab believed in the strength of our innovation, creativity and drive in the field of radiotherapy. Through our partnership, Brainlab provided us with significant support as we established our presence in the surgical device market and developed our production capabilities. Moving forward, we will continue to advance the production of Loop-X as well as coordinate research and development efforts to build next-generation systems with the objective of exploring new medical applications to improve surgical procedures and therapies. The majority acquisition by Brainlab is therefore the next logical step for us to achieve our most important goal: to advance research and development work at the highest level and expand the production of best-in-class medical technology to provide efficient therapies with optimal safety for patients." medPhoton will continue to operate as an independent research and development company within the Brainlab Group. Together, Brainlab and medPhoton will explore additional areas of application for the technology including radiotherapy, such as brachytherapy, particle therapy and intraoperative radiation therapy. Both companies will also further expand the capabilities at the medPhoton site in Salzburg, Austria. About Brainlab Brainlab is a digital medical technology pioneer founded in 1989 and headquartered in Munich. The company employs more than 2000 people in 25 locations around the globe. Brainlab serves physicians, medical professionals and their patients in over 6000 hospitals in 121 countries. Brainlab creates software-driven medical solutions that digitize, automate and optimize clinical workflows for neurosurgery, spine, trauma, craniomaxillofacial (CMF), general and vascular surgery as well as radiotherapy and radiosurgery. Core products center around surgical navigation, radiotherapy, digital operating room integration, and information and knowledge exchange. The Brainlab open framework operating system will allow third parties to develop medical applications to further advance the field of spatial computing and mixed reality. Brainlab is dedicated to creating an impact in healthcare. The company connects opportunities from emerging digital technologies to transform healthcare at scale and help improve the lives of patients worldwide. About medPhoton medPhoton develops and manufactures CE marked and FDA cleared medical devices for image guided procedures in surgery and radiation therapy, with a strong focus on particle therapy. Advanced product development centers on innovative, universal solutions for robotic, navigated applications in surgery, interventional radiology, brachytherapy and intraoperative radiation therapy (IORT). The company’s core competencies and patented solutions with X-ray-based imaging chains and algorithms are being customized for system integrators in B2B partnerships worldwide.

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HEALTH TECHNOLOGY

HeartBeam Expands Patient Population for Emergency Department Software Technology Solution

HeartBeam, Inc. | July 04, 2022

HeartBeam, Inc. a developmental stage digital healthcare company with a proprietary ECG telemedicine technology for heart attack detection, announced that HeartBeam is expanding the available patient population for the Company’s Emergency Department software technology solution. In evaluating the ECG database for the clinical validation of HeartBeam’s platform technology, a significant portion of consecutive patients fell into the category of unstable angina, a serious cardiac condition. In light of the most recent 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain and in consultation with its clinical advisors, HeartBeam elected to include the full data set for clinical validation studying in support of the 510K submission. The expanded scope of the clinical validation study will provide access to a broader patient population for HeartBeam’s technology once cleared by the FDA. Due to the expanded available patient population, HeartBeam expects to file a 510K with the full data set for clinical validation no later than August 15, 2022 and does not affect the timeline for 510K submission of the Telehealth product. “It is important to include unstable angina as a diagnosis for analysis. Patients with unstable angina may have subtle electrical changes brought on by ischemia without definitive injury to the cardiac tissue. Given HeartBeam’s advanced technology solution, there is potential to identify patients who cannot be diagnosed by traditional ECG capabilities but may require intervention.” Russell Jones, MD, Interventional Cardiologist, Chair of the Ischemia Performance Improvement Committee at Phoebe Putney Health System HeartBeam’s platform technology is anticipated to assist physicians in identifying patients who present with chest pain to facilitate rapid detection of a heart attack and determine an appropriate treatment regimen. Chest pain is the second most common reason for an emergency department visit, with high costs associated with these visits. HeartBeam’s software solution may offer more accurate heart attack detection to triage patients and expedite treatment. The HeartBeam technology platform has not yet been evaluated by the FDA and is not approved for clinical use in the USA or other global geographies. “We believe our commercialization path is on track,” said Branislav Vajdic, PhD, CEO and founder. “The decision to include the broader patient population does not impact the scheduled submission for HeartBeam’s core technology platform for our Telehealth solution, which remains on schedule to submit in Q4 2022.” About HeartBeam, Inc. HeartBeam, Inc. is a development stage digital healthcare company with proprietary ECG telemedicine technology that will redefine the way high risk cardiovascular patients are diagnosed in an ambulatory setting at any time and any place. Its breakthrough solution employs a reusable, credit card sized, 3D vector ECG recording device and cloud-based software capable of assisting a physician in diagnosing a wide range of cardiovascular disease. HeartBeam is initially focusing on a huge unmet need of helping diagnose heart attacks in patients outside of a medical institution. No single lead ECG technology can offer this value to patients and their physicians. This underserved market is several times larger than the cardiac arrhythmia detection market based on the prevalence of patients with coronary artery disease at high risk of heart attack.

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Spotlight

To market a medical device in the EU, a manufacturer must demonstrate that the device is safe, that it performs as intended, and that the risks associated with the use of the device are acceptable when weighed against the benefits to patients. Clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device to verify its clinical safety and performance. It may be based on a literature review and/or clinical experience and/or clinical investigations...

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