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Siemens Healthineers Releases Test Kit for Coronavirus COVID-19

Siemens Healthineers Releases Test Kit for Coronavirus COVID-19

Siemens Healthineers announced the availability of its molecular Fast Track Diagnostics (FTD) SARS-CoV-2 Assay test kit used to aid in the diagnosis of infection by the SARS-CoV-2 virus that causes the COVID-19 disease. Test kits are already being shipped within the European Union for research use only (RUO) to expedite availability while the company continues to pursue Emergency Use Assessment and Listing (EUAL) from the World Health Organization (WHO) for clinical use.

In addition, Siemens Healthineers has begun discussions with the U.S. FDA for release of the test under Emergency Use Authorization (EUA). Both applications are in progress. While the controlled roll- out of the assay for research use is continuing, Siemens Healthineers is simultaneously expanding its production capacity.

โ€œWith this molecular diagnostic assay, we want to make a contribution to fight the current COVID-19 global pandemic by delivering fast and accurate SARS-CoV-2 testing,โ€ said Sebastian Kronmueller, Head of Molecular Diagnostics at Siemens Healthineers. โ€œThe Siemens Healthineers assay is designed to help researchers positively identify the virus in less than three hours so that healthcare professionals can proceed as quickly as possible with the necessary next steps on their patientsโ€™ triage paths.โ€

Many molecular assays detect the presence of viral ribonucleic acid (RNA), determining the presence of the targeted virus directly in the patient sample. In this way, molecular testing is effective early in the lifecycle of the virus and is thus efficient in urgent testing situations, such as global pandemics. After regulatory approval, the commercial roll-out of the assay is intended in the U.S. and Europe.

The FTD SARS-CoV-2 Assay has been optimized on the Biomerieux EasyMag Extraction System and the Applied Biosystems 7500 Real-time PCR Thermocycler* and utilizes the same workflow, including PCR profile, as other FTD Respiratory Disease kits from Siemens Healthineers. It can be run in laboratories simultaneously with FTD Respiratory Pathogens 21**, a molecular syndromic testing panel from Siemens Healthineers that identifies 21 different upper respiratory pathogens that can cause acute respiratory infections.

The FTD SARS-CoV-2 Assay was developed by Fast Track Diagnostics, a Siemens Healthineers Company, in Esch-sur-Alzette, Luxembourg. Fast Track Diagnostics was acquired by Siemens Healthineers at the end of 2017.

Siemens Healthineers AG is shaping the future of Healthcare. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers enables healthcare providers worldwide through its regional companies to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare. Siemens Healthineers is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the companyโ€™s foundation in in-vitro diagnostic, image-guided therapy, and in-vivo diagnostics. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers ability to provide high-quality, efficient care to patients. In fiscal 2019, which ended on September 30, 2019, Siemens Healthineers, which has approximately 52,000 employees worldwide, generated revenue of โ‚ฌ14.5 billion and adjusted profit of โ‚ฌ2.5 billion.

COVID-19 Menarini Diagnostics: kit for diagnosis in 20 minutes

COVID-19 Menarini Diagnostics: kit for diagnosis in 20 minutes

Menarini Diagnostics and Credo Diagnostics Biomedical have entered into an exclusive distribution agreement for the SARS-CoV-2 assay kit and other assays for the diagnosis of respiratory infections. The tests will be run on the VitaPCRTM (Credo Diagnostics Biomedicalโ€™s Point-of-Care molecular testing platform) which allows the diagnosis of COVID-19 in just 20 minutes. The platform is already CE-marked.

The COVID-19 molecular test and instrument are fundamental to both first aid facilities and intensive care units. These diagnostics kits adopt a reaction technology of the utmost accuracy on Point-Of-Care instruments which are both compact (the size of a dictionary) and easy to use, giving a rapid diagnosis in settings such as emergency rooms, triage units, airports, seaports and railway stations.

โ€œWe have always believed that Point-of-Care molecular testing is the future. We look forward to working with Menarini to bring these tests to the market ,especially in a crisis like this, to save lives”, said Winston Wong Jr., Chairman of Credo Diagnostics Biomedical โ€œMenarini Diagnostics has been working relentlessly over the past few weeks to find a way to help healthcare workers in the fight against the virusโ€ stated Fabio Piazzalunga, General Manager of Menarini Diagnostics. โ€œWe believe it is essential to have solutions which will allow the detection of positive cases, minimise times and take screening where it is needed, running tests both rapidly and with the most accurate technology possible.

Thanks to this collaboration with Credo Diagnostics Biomedical, the Menarini Group hopes to be able to provide substantial support to healthcare workersโ€.

HOW THE TEST WORKS:

Once a nasal or oropharyngeal sample has been taken by a healthcare professional, this is inserted into a vial containing a liquid and shaken. The contents is then transferred into a second reagent tube which, once closed, will be placed inside the VitaPCRTM system, thus starting the analysis process. Within 20 minutes the test results will be displayed on the instrumentโ€™s built-in screen, confirming whether the sample analysed has proven negative or positive.

SpineGuard obtains CE mark for commercial release of its new DSG Connect platform

SpineGuard obtains CE mark for commercial release of its new DSG Connect platform

SpineGuard ,an innovative company that deploys its DSGยฎ (Dynamic Surgical Guidance) sensing technology to secure and streamline the placement of bone implants,announced the CE mark of its โ€œDSG Connectโ€platform.Already being utilized experimentally in a new strategic high value platform to guide surgical robots, SpineGuard will now apply this platformto it sentire range of products.

The attainment of the CE mark allows for the European launch of a new generation of PediGuard and โ€œsmartโ€ screw devices equipped with the DSG Connect module. DSG Connectis a tablet based software interface that adds visual interpretation to the auditory feedback for optimal exploitation of the signalduring pedicle screw placement.It also allows for data recordingof bone impedance valuesas evidence of optimal screw placement within the pedicle and for bone quality studies.

Stรฉphane Bette, co-founder and Deputy CEO of SpineGuard, said:โ€œSpineGuard affirmsits willingness to continue innovation.DSG Connect is a major step in the development of the company and the deployment of the DSG technology, not only because of the commercial potential but also due to the strategic value of this new platform. On the business side, we will launch a new range of PediGuard devices in Europe offering advanced functionalities to spine surgeon supon resumption of the elective interventions postponed due to the COVID-19 pandemic.That will allow us to energize our sales network while we monitor closely the impact on customer conversion and retention which we hope to boost thanks to the superior value proposition.

DSG Connect also demonstrates the pertinence of the DSG direct measurement of bone tissue density, performed in real-time without X-Rays, now transmitted to an external computing unit to allow for further analysis during the placement of bone implants, treatment and utilization. It is also an essential component of the application for surgical robots aiming at enhancing their safety and autonomy. We are progressing this application rapidly for which weare actively searching for strategic industry partnerships in our sector with the help of the venture bank Healthios Capital Markets.โ€

About SpineGuardยฎFounded in 2009 in France and the USA by Pierre Jรฉrรดme and Stรฉphane Bette, SpineGuard is an innovative company deploying its proprietary radiation-free real time sensing technology DSGยฎ (Dynamic Surgical Guidance) to secure and streamline the placement of implants in the skeleton. SpineGuard designs, develops and markets medical devices that have been used in over 75,000 surgical procedures worldwide. Fifteen studies published in peer-reviewed scientific journals have demonstrated the multiple benefits DSGยฎoffers to patients, surgeons, surgical staff and hospitals. Building on these solid fundamentals and several strategic partnerships, SpineGuard has expanded its technology platform in a disruptive innovation: the ยซsmartยป pedicle screw launched late 2017and is broadening the scope of applications in dental implantology and surgical robotics. DSGยฎ was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer.

Orion Health eases strain on health systems with COVID-19 patient management platform

Orion Health eases strain on health systems with COVID-19 patient management platform

Orion Health has been working closely with its customers since the beginning of the outbreak to quickly develop and deploy COVID-19 solutions that meet an individual providerโ€™s focus. The company is dedicated to finding solutions to manage the COVID- 19 pandemic, and is responding directly to its customersโ€™ specific needs and priorities with a range of different offerings.

In the space of two weeks there has been a rapid shift in the way that healthcare is delivered, from favouring face-to-face, point-to-point healthcare to using the telehealth and virtual care modalities, which allows one clinician to see many patients. The COVID-19 pandemic has forced this shift and, with it, the realisation that face-to-face healthcare will not be possible or effective in the current situation.

Orion Healthโ€™s comprehensive solution helps alleviate the pressure on overburdened global health systems, and supports the shift to the virtual care modality.

How does it work?
The solution is aimed at reducing admission to hospital and monitoring those who are at low, medium and high risk for COVID-19. It comprises a number of modules that customers can select from depending on their individual priorities.

Identify
Lists of patients can be identified and curated, for both COVID-19 negative and positive results, to highlight who would benefit from active monitoring or care as well as tracking their ongoing progress. This allows healthcare providers to maintain the visibility of
patients who are presenting symptoms or those concerned they may have had exposure to the virus.

A comprehensive reporting dashboard also allows providers to track and display the status of COVID-19 cases and report back to interested parties.

Manage

This module is where virtual care comes into its own. Providers can actively engage and manage patients before they enter the hospital (inbound), and continue the engagement with those being sent home (outbound).

Patients symptoms can be managed through digital questionnaires that allow providers to triage and stratify populations based on their own clinical protocols and risk thresholds.

This means the health system can now manage and focus on those most at-risk and reserve the need for one-on-one phone calls or consultations for those individuals who most need it, as well as ensuring visibility over imminent service demand.

Engage
Using a patient portal and secure messaging, healthcare providers can communicate directly with their patients to provide negative test results; reducing the burden on healthcare workers who have been telephoning patients โ€“ sometimes up to 300 calls per day.

Clinicians can engage with patients through secure, two-way messaging, which allows patients to contact their care providers if required and update them on their symptoms.

Whether customers opt for the entire solution, or pieces, it will help to reduce the burden on hospitals by keeping most people cared for in their own homes. Ultimately, these use case examples allow for the majority of citizens to be tracked and treated in their own homes, while ensuring precious hospital resources are reserved for those who really need them.

โ€œWeโ€™ve designed a unique, comprehensive pandemic monitoring solution specifically aimed at reducing the burden COVID-19 is placing on stretched health services globally,โ€ says Orion Health CEO Ian McCrae, who adds that these pressures are exacerbated in regions like New Zealand, which are facing the upcoming winter flu season and GP shortages.

โ€œHealth systems are being pushed to their limits and need digital systems that can help them monitor and track the spread of the virus in their region as well as keep people from coming into clinics where they are at risk of infection or infecting others. โ€œAs the number of confirmed COVID-19 cases continues to grow globally, especially in those countries currently in the community outbreak phase of the disease, there will be
a need for healthcare workers to support people from their home and our solution has been designed with this in mind.โ€

Orion Healthโ€™s COVID-19 Outbreak Management platform allows individual providers or health systems to modify the solution to their unique clinical protocols and needs. We are working with customers across the globe on solutions right now.To find out more visit orionhealth.com.

About Orion Health
Orion Health is a leading global technology company that develops software to supportthe delivery of optimised healthcare. We provide flexible technology solutions that bring together all types of health data to support the management of individualised patient care across a health system.

With over 25 yearsโ€™ experience, Orion Health has the global healthcare experience and capabilities to help organisations realise value quickly, without compromising on the local touch required for successful delivery and support.

Stryker releases Emergency Relief Bed, a limited-release medical bed to support critical needs during pandemic

Stryker releases Emergency Relief Bed, a limited-release medical bed to support critical needs during pandemic

Stryker, one of the worldโ€™s leading medical technology companies, announced it has developed a low-cost, limited-release emergency response bed to quickly aid healthcare providers with efficient care during the COVID-19 pandemic.

โ€œPeople are at the heart of what we do, and COVID-19 hasnโ€™t changed that. It has amplified our mission of making healthcare better. Weโ€™re focused on meeting the supply needs of our customers so they can focus on taking care of patients right now. Thatโ€™s why we raced to develop our Emergency Relief Bed, which will help emergency responders and caregivers move and position patients efficiently during this critical time,โ€ said Brad Saar, president of Strykerโ€™s Medical division.

Stryker anticipates producing 10,000 beds a week to meet increased needs. Strykerโ€™s Emergency Relief Bed is a low-cost, readily available solution intended to serve those on the front lines โ€“ ranging from hospital emergency departments to triage and pop-up areas of care. It includes a six-inch-thick foam surface.

The Emergency Relief Bed features a 30-degree head of bed angle to accommodate patients in respiratory distress, including ventilated patients. It also features low height and an attached IV pole.

The bed is intended for use in the COVID-19 pandemic to support increased patient numbers in healthcare facilities. Stryker is actively pursuing making the bed available in select markets around the world. Learn more about Strykerโ€™s Emergency Relief bed here.

About Stryker
Stryker is one of the worldโ€™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. More information is available at www.stryker.com.

Nemaura Plans To Launch Body-Worn Continuous Temperature Monitor to Track Fever Caused by Viral Infections such as COVID-19

Nemaura Plans To Launch Body-Worn Continuous Temperature Monitor to Track Fever Caused by Viral Infections such as COVID-19

Nemaura Medical Inc. , a medical technology company focused on developing micro-systems- based wearable diagnostic devices and currently commercializing sugarBEATยฎ, its non-invasive and flexible continuous glucose monitor (โ€œCGMโ€), announced plans for a new product line by seeking to immediately repurpose sugarBEATยฎ as a CTM since its inbuilt temperature sensor is capable of continuously tracking body temperature through the skin. Nemaura is considering various options to expedite the launch of a CTM, including potential partnerships and direct to consumer sales.

CTMโ€™s have been recognised as potentially having a key role to play in battling COVID-19, with Googleโ€™s Verily announcing plans to develop a small body worn temperature patch that transmits data to a phone application to provide timely notification of fever and support earlier diagnosis and treatment of viral infections like the flu or coronavirus1.Nemauraโ€™s body worn skin patch designed to monitor glucose levels on the skin at 5 minute intervals also contains a thermistor which measures skin temperature as an integral part of the device, and we believe that the device could easily be repurposed for this standalone function. The CGM device is CE approved in Europe and in commercial production in the UK.

โ€œWe see a significant commercial opportunity to utilise our BEATยฎ platform technology specifically for CTM purposes with data being automatically sent by low energy Bluetooth to a mobile phone app from which it can then be reviewed by the user and/or sent to a family member or caregiver. We believe that there are parallels between family members and caregivers remotely monitoring glucose fluctuations in a person, and monitoring fever caused by viral infections, providing a means of remote tracking and intervention. In the current climate we see this as an opportunity to contribute to general wellbeing and patient managementโ€ stated Dr. Faz Chowdhury, Nemauraโ€™s CEO.

Several diseases including COVID-19 are characterised by fever (an increase in body temperature) meaning that temperature monitoring can be a vital tool in the detection of such conditions and consequently a potential means of containing the spread of the disease through early self-isolation. Measuring body temperature on a continuous basis may also be used to track the course of a disease and so allow physicians to analyse the effectiveness of treatments and thus pro-actively adapt to improve outcomes.

Dr. Chowdhury further stated โ€œbody temperature can vary depending on the age of the person, their level of (recent) physical activity, the time the measurement is taken and importantly where on the body the temperature is taken. For this reason, I believe that the ability to track the temperature continuously over time and measure the rate at which it is rising or falling would be a superior form of monitoring a person than sporadic measurements taken using a more traditional thermometer.โ€

We believe that multiple other future uses are foreseen for a CTM including tracking ovulation to improve the chances of conception and for predictingย  / preventing diabetes related foot complications such as ulcers which can eventually lead to amputation if not detected early enough, whereby poor blood circulation can be rapidly detected by continuous temperature monitoring of the affected region. Further details are provided in a publication on the companyโ€™s website: View Continuous Temperature Monitoring PDF Nemaura is establishing the regulatory framework for launching the CTM in a number of worldwide territories, including initial immediate use to provide qualitative indications without disease diagnosis.

About Nemaura Medical, Inc.:
Nemaura Medical Inc. (NMRD) is a medical technology company developing micro-systems-based wearable diagnostic devices and currently commercializing sugarBEATโ„ข, and proBEATโ„ข. sugarBEATยฎ is a Class IIb CE marked non-invasive and flexible continuous glucose monitor (CGM) providing actionable insights derived from real time glucose measurements and daily glucose trend data, which may help people with diabetes and pre-diabetes to better manage, reverse and prevent the onset of diabetes. People with diabetes who take insulin can also adjunctively use sugarBEATยฎ for insulin dosage purposes when calibrated by a finger stick reading. proBEATโ„ข comprises a prescription free non-invasive glucose monitor and a digital healthcare subscription service planned to be launched in the US as a general wellness product.

LifeSignals accelerates introduction of single-use wireless medical biosensor patches for COVID-19 mass population remote monitoring

LifeSignals accelerates introduction of single-use wireless medical biosensor patches for COVID-19 mass population remote monitoring

LifeSignals Group Inc., announced that a single use, wireless biosensor patch for the early detection and monitoring of coronavirus symptoms is being fast tracked for introduction within weeks. Based on a proven platform for cardiovascular monitoring, the Biosensor Patch 1AX, simply affixed on the chest area, will record temperature, respiration rate, ECG trace, heart rate and movement โ€“ in real time.

The data is sent wirelessly from the Patch to an app on the userโ€™s phone, where the data is displayed in real-time. If symptoms develop, the data can also be sent to a secure cloud platform enabling healthcare authorities to introduce effective general population remote screening such as those placed under quarantine, patients in care home facilities or vulnerable, high risk people in their own homes.

In addition, LifeSignals is targeting June for the Patient Management Biosensor Patch 2A which captures, stores and streams clinical-grade vital signs data including SpO2. This will allow recovering coronavirus patients in intensive care units to be moved to lower dependency wards, off-site medical facilities and back to their own homes with the assurance that all of their vital sign data is being continually monitored in real-time. Allowing patients to be monitored in their own homes, Patch 2A based monitoring will assist in optimizing the use of scarce medical resources and free up hospital beds.

At the onset of a patientโ€™s vital signs showing deterioration, immediate action can be taken to avoid hospital re-admission. This new-to-market biosensor technology is the first of itsโ€™ kind to overcome the restrictions of using wireless devices within a multi-patient hospital environment. The patches can be worn for up to 5 days and can be safely disposed, reducing the risk of cross-contamination of healthcare staff.

โ€œAs soon as the serious nature of the COVID-19 outbreak became apparent, we immediately started investigating where our wireless biosensor technology could help. We identified two key areas where healthcare systems are choked; consumers calling in about symptoms they are experiencing and lack of critical care hospital beds. We activated intense effort to leverage our existing technology to produce highly reliable products to address these two areas. Our global teams are working hard to fast-track development and production of these two Patches โ€“ and we are working closely with local regulatory authorities โ€“ so we have the economics and manufacturability to reach mass populations. We believe these products will make a real difference to patientsโ€™ treatment and those who are delivering the care,โ€ says Surendar Magar, co-founder and CEO of LifeSignals.

LifeSignals have created a fully interoperable technology that can easily be integrated into most health monitoring platforms, apps and healthcare systems. We are actively seeking companies and organizations to partner with, so together, we can bring clinical-grade remote monitoring to a much wider patient base, helping reduce the burden on healthcare systems.

About LifeSignals, Inc.
LifeSignals (formerly HMicro Inc.) is the Silicon Valley based creator and producer of the patented Life Signalโ„ข Processor, a semiconductor platform designed to faithfully capture and communicate vital life signals from humans and animals to the cloud. LifeSignals is a venture capital backed, healthcare targeted, silicon and solutions company, enabled by equity investments from Flex, Uniquest, Dreamtech, Renew Group, Seraph Capital, XSeed Capital, and Reddy Capital.

Soliton Announces New Launch Plan of Next Generation Acoustic Shockwave Product Due to COVID-19

Soliton Announces New Launch Plan of Next Generation Acoustic Shockwave Product Due to COVID-19

Soliton, Inc. , a medical device company with a novel and proprietary platform technology, provided an update on its business strategy and financial position in light of the current COVID-19 situation. “In light of the widespread impact of COVID-19, our view of the ideal launch window for our RAP device has naturally changed,” commented Christopher Capelli, MD, founder, President and CEO of Soliton. “Clearly, launching an aesthetic device during a national crisis such as the COVID-19 pandemic would be ill-advised.

Fortunately for us, though the delay of our limited market launch costs us some time, it has also had a valuable upside. Instead of launching our RAP device focused solely on tattoo removal in mid-2020, we are electing to delay that launch until the aesthetic and financial markets are demonstrating more stability. In the meantime, we will remain highly focused on our regulatory pathway for cellulite

reduction. We now believe our initial launch could be timed appropriately to incorporate both tattoo and cellulite indications, subject to FDA clearance of the latter. We are all hopeful that this strategic shift allows sufficient time for our dermatology customers and the market in general to return to some sense of normalcy.”

Soliton recently announced that we will be sharing the results from the 12-week follow-up of our pivotal cellulite study through the American Academy of Dermatology’s virtual meeting expected to be held in the next 5 – 7 weeks. It is this data that will provide the clinical basis for our planned regulatory filing. At this time, we do not anticipate a delay in our regulatory plans for the cellulite indication and plan to file our 510(k) in the second quarter of 2020.

As many dermatologist offices are currently closed, we are experiencing follow-up visit cancellations in our ongoing 26-week cellulite assessment and

increased difficulty in executing the initiation of further clinical trials at sites around the country. While this will not impact the regulatory pathway for the initial cellulite indication, there is the expectation this will impact the timing of Soliton’s planned additional hypertrophic scar proof-of-concept study and the longer-term 26-week follow-up visits in our cellulite pivotal study. Furthermore, it is possible this may extend the time required to file for additional, improved cellulite reduction claims with the FDA and for initial approvals of a hypertrophic scar indication that we may seek in the future.

Given the modification in our timeline and the instability in the financial markets, we have modified our spending plans and now expect our cash on hand to finance our operations to December 2020, assuming that we do not encounter any unforeseen costs or expenses. We will modulate our launch timeline with early indicators of the recovery of the financial and aesthetic markets, with the objective of identifying an appropriate window of opportunity for a successful product debut.

Dr. Capelli concluded, “Despite the turmoil created by COVID-19, Soliton remains focused on executing it’s 2020 milestones related to the regulatory pathway for cellulite and implementing new initiatives to drive continued business momentum. Although our commercialization timeline has been modified and we are facing incremental challenges, we remain committed to our long-term goal of providing our customers with the innovative Rapid Acoustic Pulse technology and generating long-term shareholder value. We appreciate for your continued interest and support in Soliton.”

About Soliton, Inc.

Soliton, Inc. is a medical device company with a novel and proprietary platform technology licensed from MD Anderson. The Company’s first FDA cleared commercial product will use rapid pulses of acoustic shockwaves as an accessory to lasers for the removal of unwanted tattoos. The Company is based in Houston, Texas, and is actively engaged in bringing the Rapid Acoustic Pulse (“RAP”) device to the market. The Company believes this “Soliton” method has the potential to lower tattoo removal costs for patients, while increasing profitability to practitioners, compared to current laser removal methods. Soliton is investigating potential additional capabilities of the RAP technology in clinical and preclinical testing, including the potential to improve the appearance of cellulite by creating mechanical stress at the cellular level and inducing significant collagen growth and the potential to treat keloid and hypertrophic scars by targeting the stiffened environment in the intracellular matrix.

BD, BioMedomics Announce Launch of Rapid Serology Test to Detect Exposure to COVID-19

BD, BioMedomics Announce Launch of Rapid Serology Test to Detect Exposure to COVID-19

BD , a leading global medical technology company, and BioMedomics, a privately held, North Carolina-based clinical diagnostics company, announced the release of a new point-of-care test that can detect antibodies in blood to confirm current or past exposure to COVID-19 in as little as 15 minutes.

The new test, developed and manufactured by BioMedomics, will be available through BD and distributed exclusively by Henry Schein, Inc. to health care providers throughout the United States. The test does not require special equipment and may be used in a laboratory or at the point of care. The test detects antibodies in the blood that are produced by the body in response to coronavirus infection.

These antibodies are typically present in the middle to later stages of COVID-19 infection, but may remain present after exposure, which helps clinicians determine who has been exposed to the coronavirus, even if a person didn’t exhibit any symptoms of the COVID-19 disease. Data on past exposure is important for researchers to more accurately understand the likely true occurrence of SARS-CoV-2 infection across a population. This information will be helpful in informing future strategies for combatting COVID-19.

“Serology tests are important because they provide an additional piece of information to aid in characterizing possible prior exposure to SARS-CoV-2, especially since many infections are mild or asymptomatic in severity,” said Dave Hickey, president of Integrated Diagnostic Solutions for BD. “Initial evidence suggests that nearly all patients infected with SARS-CoV-2 will have developed a detectable antibody response within days of symptom onset, at which time a negative serologic test, along with molecular diagnostics, could be helpful in ruling out COVID-19. Our agreement with BioMedomics adds a rapid serology test that can augment current tests already on the market, and we are pleased to collaborate in this effort with Henry Schein, which has extensive knowledge of the point-of-care test field.”

The test is completed in four, simple steps. First, blood is collected through normal blood collection devices such as the BD Microtainerยฎ Contact- Activated Lancet. A few drops of blood are then transferred to the test cartridge, followed by two to three drops of a buffer. The results can be read in 15 minutes, similar to how over-the-counter pregnancy tests show multiple lines for positive results and a single line for negative results.

“BioMedomics designed the test to be easy to use and provide results in minutes, with no special equipment necessary or the need to transport the sample to a laboratory for analysis,” said Frank Wang, CEO of BioMedomics. “Our test has been clinically validated at several hospitals and clinical laboratories in both the U.S. and China, and our published clinical data in the Journal of Medical Virology was one of the world’s first for a COVID-19 serology test. It has been used widely in China during the COVID-19 outbreak and is now ready to help combat coronavirus in the U.S. through our collaboration with BD. We are committed to doing our part to battle this disease and are excited to have BD as a partner to help deliver our high- quality rapid test to those who need it most.”

The test analyzes blood, serum or plasma samples for the presence of immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies associated with the coronavirus (SARS-CoV-2). IgM provides the first line of defense during viral infections, followed by the generation of adaptive, high-affinity IgG responses for long-term immunity and immunological memory. The detection of COVID-19 IgM antibodies tends to indicate a recent exposure to COVID-19, and detection of COVID-19 IgG antibodies indicates a later stage of infection, so this combined antibody test could also provide information on the stage of the disease in patients. Current guidance from the U.S. Food and Drug Administration (FDA) recommends that results from antibody testing should not be used as the sole basis to diagnose or exclude coronavirus infection. Depending on the clinical scenario, additional testing, such as those used on the BD MAXโ„ข System may be considered to further evaluate the possibility of SARS-CoV-2 infection.

“We look forward to working with such an outstanding company as BD to help make the antibody test part of the standard of care,” said Stanley M. Bergman, Henry Schein’s chairman of the board and chief executive officer. “The test will help to identify people who have developed antibodies to the virus, which may inform future strategies regarding COVID-19.”

The test has not been reviewed by the FDA but is permitted for distribution and use under the public health emergency guidance issued by FDA on March 16, 2020, and BD expects to begin shipping tests in April. BD will have capacity to supply more than one million tests over the coming months, with the ability to scale up based on market demand and is working with medical products distribution company Henry Schein to make these tests available to medical care facilities throughout the United States. Health care providers can order the test and all collection devices needed to perform the test by contacting their BD or Henry Schein representatives.

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 healthcare by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for healthcare providers. BD and its 65,000 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 healthcare. For more information on BD, please visit bd.com.

About BioMedomics

BioMedomics is a point-of-care diagnostics company that aims to provide novel, rapid point-of-care tests to aid in the diagnosis of critical diseases. The company uses cutting-edge technology to create life-saving diagnostic solutions and address global health care needs. Its diagnostic tests produce rapid and accurate clinical results at the point-of-care without requiring complex and expensive lab equipment โ€” placing immediate health care knowledge in the hands of providers. With that knowledge comes the power to make treatment decisions and save lives.

United Imaging sends out More than 100 CT Scanners and X-Ray machines to aid diagnosis of the Coronavirus

United Imaging Sends Out More than 100 CT Scanners and X-Ray Machines to Aid Diagnosis of the Coronavirus

United Imaging employees across the globe extend our thoughts and condolences to those affected by the coronavirus. To help front-line physicians, nurses, and other healthcare professionals diagnose and treat the coronavirus, United Imaging has donated medical imaging equipment and protective medical gear worth more than $1.4 million to hospitals in Wuhan, China, at the center of the outbreak.

On Feb. 1, United Imaging also finished installation of three high-end CT scanners โ€” one uCT 780 (160-slice CT scanner) and two uCT 760s (128-slice CT scanners) โ€” at the Huoshenshan Hospital, an emergency specialty field hospital with 1,000 beds built in less than 10 days in Wuhan. United Imaging accomplished the installation while the hospital was under construction, within half the time it usually takes to install this equipment.

The company dispatched 15 service engineers to work in three continuous shifts, as well as a 25-person team that included
project managers, clinical application professionals, and operations to provide on-site support.

At the same time, the company set up additional spare parts sites near the hospital to ensure a quick response in case of need. United Imaging also accelerated production to get more than 100 CT scanners and X-ray machines out quickly to hospitals in Wuhan, Shanghai, Beijing, Zhejiang, Inner Mongolia, and other regions in China.

With scanning workflow fully empowered by AI technology, United Imaging CT systems enable automatic patient positioning and scanning from the operation room. Because technologists donโ€™t have to go into the scan room, this feature can help prevent cross infection between technologists and patients. Also, the ability to scan more than 300 patients daily provides a robust foundation for smooth and efficient hospital operations.

United Imagingโ€™s engineers are standing by 24 hours a day to respond to emergency calls from hospitals. Along with these engineers, hundreds of United Imaging employees have been contributing to this effort for more than ten consecutive days, working through holidays and returning early, to support the healthcare professionals across China fighting the coronavirus.

United Imaging also deployed its UIH CLOUD remote diagnosis platform in frontline hospitals as soon as the outbreak occurred. With this platform, patient images scanned at designated hospitals can be uploaded to the top hospitals in China in order to support remote, real-time diagnosis and guidance from doctors. According to reports, the platform achieved more than 1,000 diagnoses at one hospital in just one week.

As a global company, United Imaging is committed to access for all to the best possible care worldwide and is proud to play a small part alongside so many who are going above and beyond in this moment.

ABOUT UNITED IMAGING

At United Imaging, we develop and produce advanced medical products and IT solutions that cover the entire process of imaging diagnosis and treatment. Founded in 2011 with global headquarters in Shanghai, our company has subsidiaries and R&D centers across China, the United States, and other parts of the world. Our U.S. R&D facility opened in 2013 in Houston and was further established as the U.S. headquarters in 2018 with our service team and commercial organization in place. With a cutting-edge digital portfolio and a mission of broader access to healthcare for all, we help drive industry progress and bold change.

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