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Exero Medical Completes First In-Human Implant of Wireless Anastomotic Leak Sensor at Rabin Medical Center

Exero Medical Completes First In-Human Implant of Wireless Anastomotic Leak Sensor at Rabin Medical Center

Exero Medical, developer of a wireless sensor for early detection of anastomotic leaks following GI surgery, announced it has completed the first human implantation of its sensor. The implant procedure was part of an ongoing clinical trial conducted at Rabin Medical Center led by Prof. Nir Wasserberg, chairman of the Israel CRS society and director of colorectal division.

The study team reported the successful placement of the sensor and data collection during low anterior resection surgery for rectal cancer.

“The initiation of clinical data collection is a critical step towards providing a reliable detection tool for surgeons,” explained Prof. Wasserberg. “The fear of anastomotic leak is the one that keeps GI surgeons up at night and one that represents a true clinical need. Exero’s sensor is designed to provide surgeons with insight on patients’ healing processes so they can determine the best course of action and improve clinical outcomes.”

Dr. Erez Shor, CEO of Exero Medical stated: “We are extremely encouraged by this successful first case and the technical performance of the device in the operating room. This is a significant milestone for Exero Medical. We look forward to developing a reliable anastomotic leak detection system, that will save lives, reduce suffering and address a challenge currently costing billions of dollars for payers and providers.”

The surgeons involved in the trial have also reported positive feedback on the Exero sensor’s easy integration into the patient workflow during the procedure. As a result of the sensor’s design and materials, surgeons are able to add the sensor implantation to current operating procedure with minimal added time and negligible added risk to the patient.

About Exero Medical

Founded in 2018 by the MEDX Xelerator, an Israeli Innovation Authority incubator and Clalit HMO, the largest HMO in Israel, Exero Medical goal is to save lives through early detection of anastomotic leaks following gastrointestinal (GI) surgeries, addressing a $2 billion market with its sensor technology. The company has created a patent-pending implantable biodegradable wireless sensor designed to continuously monitor the GI tract near the surgical site, alerting physicians to potential anastomotic leakage post-operation and also enabling early patient discharge by identifying proper tissue healing. Exero Medical is backed by seed investment from the MEDX Xelerator, Boston Scientific, MEDX Ventures and Intellectual Ventures.

Paige Receives FDA Clearance for the FullFocus Viewer for Digital Pathology

Paige Receives FDA Clearance for the FullFocus Viewer for Digital Pathology

Paige, a specialist in computational pathology, has announced it has received FDA 510(k) clearance for the FullFocusโ„ข viewer for primary diagnosis of digital pathology slides. While the FullFocus viewer intuitively allows pathologists to view and navigate images from all major commercial brands of scanners, this clearance initially applies to FullFocus when used together with the Philips Ultra Fast scanner.

Lack of interoperability, intensive capital requirements and burdensome, on-premise storage has long been a challenge in the adoption of digital pathology. The foundation for the FullFocus viewer was initially created and validated at Memorial Sloan Kettering Cancer Center (MSK) to allow researchers and pathologists to view any digital image regardless of the scanning platform used to generate the image. After refinement based on 18 months of daily use for retrospective slide review by dozens of practicing pathologists at MSK, the viewer was further enhanced by Paige to meet the system requirements for primary diagnosis, with optimized viewing speeds and adherence to a certified quality management system. In order to provide a flexible solution for hospitals, Paige is working to expand upon the clearance to incorporate use with additional scanners and monitors in the near future.

โ€œThe COVID-19 pandemic has made it painfully clear that pathologists need better solutions to work safely and remotely,โ€ said Leo Grady, PhD CEO at Paige. โ€œPathology labs, hospitals and biopharma companies need to serve patients and conduct research with little disruption, without having to be physically present at their labs. Receiving FDA clearance for the FullFocus viewer allows Paige to further its commitment to modernizing workflows for pathologists so that they can manage their ever-increasing workloads in an efficient, organized, collaborative and secure way and ultimately help patients get the right care at the right time.โ€

The FullFocus viewer operates within the Paige Platform, which also offers fully-managed, cost-effective storage capabilities. The combined offering can be quickly deployed in any clinical setting, requires minimal upfront costs and allows for collaboration between geographically distributed pathologists, streamlining the path to digital pathology. The Paige Platform is also designed to deliver best-in-class computational pathology products.

In November 2019, FullFocus received the CE Mark, opening its use to European pathology practices. Paige has early access trials across the United States, Europe and Brazil, with healthcare organizations interested in better serving patients and maintaining business continuity.

Dedalus Acquires DXC’s Provider Healthcare Business

Dedalus Acquires DXC's Provider Healthcare Business

DXC Technology announced a definitive agreement to sell DXC’s healthcare software provider business to privately held Dedalus Group for $525 million in cash.

The agreement brings together DXC’s software business for healthcare providers with Dedalus, a leading European healthcare and diagnostic software company, to create an even stronger global force in the clinical IT areas of hospital information systems (HIS), primary and social care, integrated care and diagnostics. The resulting business will be uniquely positioned to accelerate the digital transformation of clinical activity and consequently the effectiveness of healthcare systems.

DXC’s healthcare provider software business is a recognized leader in the healthcare sector. Among its innovations is an open digital health platform that helps improve care outcomes by delivering contextual and actionable insights across the healthcare ecosystem. 

“The sale of our healthcare provider software business to Dedalus is consistent with our strategy of focusing on the Enterprise Technology Stack and rationalizing our portfolio. The transaction promises to be beneficial to all our key stakeholders, including our customers and our people,” said Mike Salvino, president and chief executive officer, DXC Technology. 

“The addition of DXC’s healthcare software business will accelerate our growth initiatives that started three years ago and benefit the more than 3 million healthcare professionals who use our technology to treat more than 200 million patients every year,” said Giorgio Moretti, executive chairman of the Dedalus Group. 

The transaction was approved by DXC’s Board of Directors and is expected to close by March 2021, subject to the satisfaction of customary closing conditions and the receipt of certain third-party consents and regulatory approvals. The sale is not subject to any financing conditions or shareholder approvals. 

About the Transaction

Mizuho Securities USA LLC acted as financial advisor and Latham & Watkins LLP acted as legal advisor to DXC. UBS Securities acted as financial advisor and Clifford Chance acted as legal advisor to the Dedalus Group. 

About DXC Technology

DXC Technology (NYSE: DXC) helps global companies run their mission critical systems and operations while modernizing IT, optimizing data architectures, and ensuring security and scalability across public, private and hybrid clouds. With decades of driving innovation, the world’s largest companies trust DXC to deploy our enterprise technology stack to deliver new levels of performance, competitiveness and customer experiences. 

About Dedalus

Founded in Florence in 1982, Dedalus Group is the leading healthcare and diagnostic software provider in Europe and one of the largest in the world. The shareholding structure ensures stability and great financial capacity through the presence of Ardian, the largest private investment company in Europe and 4th in the world.

Starting in 2016, Dedalus has decided to accelerate its expansion strategy by targeting a growing demand for innovative and comprehensive ICT and Clinical transformation solutions. With the acquisition of Agfa Healthcare IT, Dedalus consolidates its leadership as a pan-European player in the healthcare software industry, with a market leading position in Hospital IT (HCIS) and Diagnostic (DIS) in Germany, Italy and France, with a strong footprint in Austria, Switzerland, Spain, Belgium, China, Brazil and several locations in Latin America, Middle East and Africa, reaching over 30 different countries. Today Dedalus employs over 3,500 highly skilled resources; it has the largest R&D software team in the sector in Europe with more than 1,100 people. Thanks to its undisputed cutting-edge portfolio of leading new generation solutions, Dedalus covers the whole spectrum of needs for healthcare operators, supporting over 5000 hospitals and 5000 laboratories around the world. 

ndd’s new inline filters offer additional protection against COVID-19 during lung function tests

ndd's new inline filters offer additional protection against COVID-19 during lung function tests

ndd Medical Technologies (ndd), a leading provider of diagnostic technology enabling healthcare professionals the early detection of COPD and other chronic lung diseases, has introduced new single patient-use, inline filters for its lung function testing devices, in response to the global COVID-19 pandemic. Ensuring an added level of safety, the new filters can be used with nddโ€™s revolutionary, and highly portable EasyOneยฎ spirometry range, including the EasyOne Air, EasyOne Pro, and EasyOne ProLAB. EasyOne spirometers are popular among pulmonologists and medical researchers as they are of the most sensitive devices available, delivering reliable, real-time lung function results and diagnosis of chronic lung diseases, even at the point of care.

COVID-19 has had a massive impact on global healthcare systems, and the safety of both patients and healthcare professionals during lung function testing is paramount.1In addition, as the SARS-CoV-2virus is known to affect the lungs, there is growing research into the effects of COVID-19 on lung function post-infection.2

The EasyOne product line was originally designed with a strong focus on infection control with easy-to-wipe surfaces, single-use parts for anything that comes into contact with a patientโ€™s breath, and nddโ€™s unique spirette and flow tube design which protects the flow sensor from cross-contamination. Now, when performing spirometry and testing of the diffusing capacity of the lungs for carbon monoxide (DLCO tests), the new EasyOne inline, single patient-use filters provideโ€œdouble protectionโ€ for technicians and patients by keeping the ambient environment clean, without significantly affecting the EasyOneโ€™s sensitivity.3

Leading pulmonologists and medical researchers around the world use nddโ€™s lung function testing products due to portability, which means they can easily be used in point of care settings, and because they are of the most sensitive devices available.nddโ€™s rigorous sensitivity tests have shown that the new inline filters do not significantly affect this sensitivityand show comparable results in 24 waveform testing, (as required by ATS/ERS) and pass testing requirements3. World-renowned medical research organizationsโ€”such as Johns Hopkins University, University Hospital Zurich and University of Cape Townโ€”are partnering with ndd to assess the long-term lung damage caused by SARS-CoV-2.

Dr Trishul Siddharthan, Assistant Professor of Pulmonary and Critical Care Medicine at Johns Hopkins University, commented, โ€œThere is a lot of research underway to investigate the long-term effects of COVID-19. Our research group has been partnering with ndd thanks to the reliability of these spirometers in global settings and the ease of cleaning these devices during the pandemic to ensure safety.โ€

Prof. Friedrich Thienemann, General Medicine & Global Health research group, University of Cape Town and University Hospital Zurich, also noted, โ€œIn order to measure lung functions in resource-constraint settings like South African townships, one needs a device that is portable, point-of-care, easy-to-use, low-maintenance, and reliable without complicated calibration. EasyOne Pro LAB is that device.โ€

Incorporating nddโ€™s patented TrueFlowTM ultrasound technology, the EasyOne translates airflow into ultrasound signals which are measured by the sensors, so the patientโ€™s breath does not come into contact with the sensors. This helps to prevent contamination and minimizes the cleaning required for safe use, while enabling a lifetime of calibration-free accuracy for flow and volume measurements.

Georg Harnoncourt, ndd Medicalโ€™s CEO, commented: โ€œAt ndd we have always designed our lung function testing products with safety in mind, so since the onset of the COVID-19 pandemic, we have worked tirelessly to develop additional infection control measures to protect both technicians and patients. Our EasyOne spirometers already offer superior infection control as everything that comes into contact with a personโ€™s breath is replaced after use. In addition, our new inline filters have been carefully designed and tested so that, in combination with this superior infection control design, you can continue critical lung function testing during the COVID-19 pandemic as safely as possible.โ€

About ndd Medical Technologies

Founded in 1992 by Professor Karl Harnoncourt, ndd Medical Technologies Inc. isthe global leader and innovator in lung function testing and PFT devices. For more than 20 years,ndd has worked to improve the early detection and accurate diagnosis for people living with COPD and other chronic lung diseases with EasyOne productsโ€”by supporting research, helping to create awareness and launching innovative products and making them available to over 100 countries.

The EasyOne product line was developed for physicians to offer accurate and reliable diagnosis at the point of care and start immediate treatment. This helps avoid irreversible lung damage for millions of patients while significantly reducing healthcare costs.

ViruShield launches the ViruShield Ghost as new innovative solution to cloth mask

ViruShield launches the ViruShield Ghost as new innovative solution to cloth mask

ViruShield, a California-based company that creates groundbreaking products to mitigate against the emergence of COVID-19 through inventive design and state-of-the-art technology, announces the launch of the ViruShield Ghost. The patent pending Ghost is a transparent, strapless, and reusable respiratory shield that is an alternative for individuals who have difficulty breathing while wearing a fabric mask or other face covering.

In these uncertain times, the Centers for Disease Control and Prevention (CDC) has issued guidelines, including recommendations that people wear face coverings in public settings, especially when other social distancing measures are difficult to maintain. The ViruShield Ghost, in compliance with many newly enacted state-level ordinances, serves as a meaningful alternative for those individuals who have difficulty breathing while wearing cloth masks or face coverings.

โ€œOur innovative patent pending designs were developed to help ease the minds of consumers as they continue to navigate these uncertain times and to make a positive impact within the PPE industry, while complying with the CDC guidelines,โ€ said Carl Savoia, Chairman and CEO of ViruShield. โ€œAs we continue to monitor the regularly changing safety recommendations, we are committed to providing consumers with a safe alternative to regular face masks to ensure their health is not put at risk from breathing complications.โ€

The Ghost, which is the first of a multi-product launch coming soon, is designed as a practical face covering created for non-medical purposes and is currently being sold in a three pack on ViruShieldโ€™s website for $19.99. The product comes with medical grade adhesive tabs to place on the userโ€™s nose where desired for the best fit and is intended for multiple uses. ViruShieldโ€™s lightweight and easy to clean protective gear includes a transparent respiratory shield for better communication and better facial recognition, which is ideal for the hearing impaired who rely on lip reading. The new, innovative design of the Ghost promotes a safer way for consumers to breathe and to avoid any potential health risks from wearing a mask for long periods of time.

UK government to launch free finger-prick Covid-19 tests

Roche's SARS-CoV2 antibody test will help evaluate the patients immune response to the virus

The UK government is set to launch free Covid-19 antibody tests, which deliver results in 20 minutes, following finger-prick after successful secret trials.

The test was found to be 98.6% accurate in secret human trials. It has been developed by the UK Rapid Test Consortium (UK-RTC), a partnership between Oxford University and leading UK diagnostics companies.

It utilises full-length spike protein part of the virus to capture IgG antibodies as blood passes through the home test.

The first major clinical trial for the test, which involved nearly 300 people, was conducted by scientists at Ulster University last month.

The AbC-19 lateral flow test is the first approved antibody test for Covid-19 in the UK that generates instant results. Other approved diagnostic tests take days to provide the result as the blood samples need to be sent to laboratories for analysis.

The new test is expected to obtain regulatory approval in the next few weeks and will be launched for use in a mass screening programme before the end of the year.

According to the report, tens of thousands of prototypes have already been manufactured in factories across the UK.

According to the government plans, the tests will be first distributed to healthcare professionals before being rolled out across the country for people to use at home.

Last month, Abingdon Health, a member of the UK-RTC, said that the consortium is working with NHSX to develop a test-specific app and digital service that will facilitate use and reading of the test device.

The company also revealed that critical planning around supply chain logistics was also well underway.

Bioventus Makes $15 Million Equity Investment in CartiHeal to Acquire Company Upon Milestone Achievements

Bioventus Makes $15 Million Equity Investment in CartiHeal to Acquire Company Upon Milestone Achievements

CartiHeal, developer of the proprietary Agili -C implant for the treatment of joint surface lesions in traumatic and osteoarthritic joints, has secured an additional $15 million equity investment from Bioventus, a global leader in orthobiologics. The investment follows the recently completed enrollment and outcome of interim analysis in CartilHealโ€™s investigational device exemption (IDE) multinational pivotal study. An additional $5 million can be secured by CartiHeal from Bioventus, if needed, for IDE study completion.

This new round of funding is expected to enable CartiHeal to complete all patient follow-up in the study and submit a first application for premarket approval (PMA) to the FDA. Bioventus made an initial $2.5 million investment in the Agili-C IDE study in January 2018, as part of a previous financing round.

Bioventus and CartiHeal have agreed on an option structure under which Bioventus will acquire the company shortly after FDA approval of the Agili-C implant. Terms of that option structure are not disclosed.

โ€œWe are pleased Bioventus continues to see value in the Agili-C implant and is making a greater investment to support the completion of the IDE study,โ€ said Nir Altschuler, founder & CEO, CartiHeal. โ€œWe look forward to the work ahead and a successful application for PMA approval.โ€

โ€œThe successful enrollment and outcome at the interim analysis of CartiHealโ€™s pivotal study for Agili-C implant is an important milestone,โ€ said Ken Reali, CEO, Bioventus. โ€œIt is a testament to the strength of its continuing development program and more importantly the future potential of the Agili-C technology in addressing the large unmet need in patients with joint surface lesions. This investment underscores our belief in the novel technology and we look forward to working with the team at CartiHeal in the years to come.โ€

About CartiHeal
CartiHeal, a privately-held medical device company with headquarters in Israel, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.

About the Agili-C implant IDE multinational pivotal study
The trialโ€™s objective is to demonstrate the superiority of the Agili-C implant over the surgical standard of care (microfracture and debridement) for the treatment of cartilage or osteochondral defects, in both osteoarthritic knees and knees without degenerative changes. It includes more than 250 patients in centers in the US, Europe and Israel.

About Bioventus
Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The orthobiologic products from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone healing. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide.

Humana and REACH Kidney Care Sign Care Coordination Services Agreement

Humana and REACH Kidney Care Sign Care Coordination Services Agreement

Leading health and well-being company Humana Inc. and REACH Kidney Care, a separate nonprofit affiliated with Dialysis Clinic, Inc. (DCI) focused on Chronic Kidney Disease (CKD) education and care management, announced an agreement to provide kidney disease care coordination services to eligible Humana Medicare Advantage and Commercial members in Alabama, North Carolina, South Carolina, and Tennessee. The services are designed to help Humana members with kidney disease improve their health and quality of life through a more customized, integrated approach to care.

The collaboration, now in effect, is focused on early detection of CKD, slowing disease progression, and improving the patient experience by coordinating care in conjunction with a memberโ€™s primary care physician and nephrologist. REACH Kidney Care nurses, pharmacists, and dietitians will provide patient education about in-home treatment options, including home dialysis; and health and medication assessments.

โ€œThis partnership is part of Humanaโ€™s dedication to innovation, especially in meeting care challenges presented by the coronavirus. Weโ€™re committed to offering our members with kidney disease a modern, personalized strategy that provides synchronized care options,โ€ said Amal Agarwal, M.D., Humanaโ€™s Vice President of Transformative Home Solutions. โ€œThis whole-person approach to treating chronic kidney and end-stage renal disease provides our members greater choice and flexibility in their care, including for some the option for in-home treatment.โ€

โ€œWeโ€™re delighted to provide care management services through this agreement with Humana, as we mutually view each patient as an individual who deserves the best possible quality of life,โ€ said Doug Johnson, M.D., DCIโ€™s Vice Chairman of the Board and co-founder of REACH Kidney Care. โ€œAs a kidney health organization, we also share with Humana a devotion to changing the status quo and providing real solutions in caring for people with chronic kidney disease.โ€

It is estimated that in the United States, more than one in seven adults has CKD, with many unaware of their condition. Individuals with CKD have kidneys that cannot properly filter blood, causing waste and fluid levels that can be dangerously high. Management of CKD is complex, and failure to appropriately manage the condition may cause worsening health outcomes and considerable symptoms.

About REACH Kidney Care and Dialysis Clinic, Inc. (DCI)

Founded in 1971, DCI is the nation’s largest non-profit dialysis provider addressing a person’s kidney care needs from early detection, intervention, dialysis treatment, transplantation and end of life care. Headquartered in Nashville, Tennessee, DCI operates more than 250 dialysis clinics in 28 states. DCI clinics offer in-center hemodialysis, home hemodialysis, peritoneal dialysis and support to 147 hospital programs around the U.S.

DCI founded REACH Kidney Care seven years ago with a primary goal to keep people off dialysis. REACH Kidney Care is a comprehensive kidney health management program. REACH Kidney Care provides strategies to manage and help delay the progression of kidney disease and provide education and care management to those transitioning into kidney failure. DCI started DCI Donor Services to save and enhance lives through organ and tissue donation and transplantation. Because of the efforts of the team at DCI Donor Services, 724 people received a life changing transplant in 2019.

About Humana

Humana Inc. is committed to helping our millions of medical and specialty members achieve their best health. Our successful history in care delivery and health plan administration is helping us create a new kind of integrated care with the power to improve health and well-being and lower costs. Our efforts are leading to a better quality of life for people with Medicare, families, individuals, military service personnel, and communities at large.

To accomplish that, we support physicians and other health care professionals as they work to deliver the right care in the right place for their patients, our members. Our range of clinical capabilities, resources and tools โ€“ such as in-home care, behavioral health, pharmacy services, data analytics and wellness solutions โ€“ combine to produce a simplified experience that makes health care easier to navigate and more effective.

Baystate Health and Kindred Healthcare Announce Planned Joint Venture Behavioral Health Hospital In Western MA

Baystate Health and Kindred Healthcare Announce Planned Joint Venture Behavioral Health Hospital In Western MA

Baystate Health and Kindred Healthcare, LLC announced plans to form a joint venture that will build and operate a $43 million state-of-the-art behavioral health hospital in western Massachusetts.

The new 120-bed facility will address the shortage of behavioral health beds in the region โ€“ increasing patient access to Baystate Healthโ€™s specialty inpatient behavioral healthcare for adults (including geriatrics), adolescents and children by more than 50%. Kindred will manage day-to-day operations of the hospital, and Baystate Health psychiatrists and advanced practitioners will provide care under the medical leadership of Barry Sarvet, MD, Chair of Psychiatry, Baystate Health.

The hospital will be designed specifically for behavioral health services to foster a better healing environment for patients. The hospital will feature distinct units to meet patientsโ€™ varying treatment needs and is expected to employ more than 200 direct caregivers and ancillary staff.

โ€In building a state-of-the-art behavioral health facility to serve the areaโ€™s most vulnerable patients, we recognize that such a major undertaking could not be achieved without a quality partner. Kindredโ€™s strength in building and operating specialty hospitals coupled with Baystateโ€™s behavioral health clinical expertise is the perfect fit. We are looking forward to creating an unparalleled community resource dedicated to the needs of all behavioral health patients,โ€ said Dr. Mark A. Keroack, president and CEO of Baystate Health.

โ€œOur partnership with Baystate creates a unique opportunity to expand access to high-quality behavioral health services in western Massachusetts,โ€ said Rob Marsh, Senior Vice President and Chief Operating Officer for Kindred Behavioral Health (โ€œKBHโ€), โ€œKindred is a leader in treating medically complex and rehab-intensive patients, leveraging partnerships and innovation to enhance care. Through KBH, we are building upon our existing clinical and operational capabilities to address the unmet need for behavioral health services.โ€

Baystate Health remains interested in a centrally located Holyoke location and is in discussions with the City of Holyoke regarding the potential acquisition and development of the property on Lower Westfield Road.

It is anticipated that from the time the site is secured, it will be at least two years before the new hospital is operational, pending regulatory and other approvals.

Until the new hospital is completed, Baystate will continue to operate its inpatient behavioral health units at its community hospitals – Baystate Franklin Medical Center, Baystate Noble Hospital and Baystate Wing Hospital. Upon completion of the new facility, these units will be closed.

Emergency care services will continue to be provided at all Baystate Health hospitals, and the treatment of medically complex patients will continue at Baystate Medical Center in its Adult Psychiatric Treatment Unit.

About Baystate Health
Baystate Health is a not-for-profit integrated healthcare system serving over 800,000 people throughout western Massachusetts. Nationally recognized as a leader in healthcare quality and safety, Baystate Health has more than 12,000 employees and serves a diverse population of patients at its teaching hospital, Baystate Medical Center in Springfield, as well as at Baystate Children’s Hospital, its three community hospital, several urban health centers, home care and hospice services, and a network of over 80 medical practices. A leader in medical education for more than a century, Baystate Health along with the University of Massachusetts Medical School recently established the first medical school campus in western Massachusetts call UMMS-Baystate.

About Kindred Healthcare
Kindred Healthcare, LLC is a healthcare services company based in Louisville, Kentucky with annual revenues of approximately $3.2 billion(1). At March 31, 2020, Kindred through its subsidiaries had approximately 31,800 employees providing healthcare services in 1,731 locations in 46 states, including 64 long-term acute care hospitals, 21 inpatient rehabilitation hospitals, 10 sub-acute units, 95 inpatient rehabilitation units (hospital-based), contract rehabilitation service businesses which served 1,541 non-affiliated sites of service, and behavioral health services. Ranked as one of Fortune magazineโ€™s Most Admired Healthcare Companies for nine years, Kindredโ€™s mission is to help our patients reach their highest potential for health and healing with intensive medical and rehabilitative care through a compassionate patient experience.

FDA Authorizes Quest Diagnostics COVID-19 Diagnostic Testing for Specimen Pooling for Emergency Use

Todos Medical Announces First Commercial Sale of COVID-19 Antibody Tests

Quest Diagnostics, the world’s leading provider of diagnostic information services, announced that it has received emergency use authorization (EUA) from the U.S. FDA to use specimen pooling with its proprietary molecular diagnostic test for COVID-19. Quest is the first lab provider to receive FDA authorization for the technique for COVID-19 testing in the United States.

In pooling, specimens must still be collected into individual vials, but then are combined into small batches or pools by the laboratory. A negative result for a batch means that all patients in that pool are considered negativeย (If a positive result occurs for the batch, each specimen is retested individually). The technique is an efficient way to evaluate patients in regions or populations with low rates of disease. Pooling is used routinely in blood banking to screen donated blood for a variety of viruses, among other applications.

With the new pooling EUA, the Quest Diagnostics SARS-CoV-2 RNA (“Quest SARS-CoV-2 rRT-PCR”) test* may be used with pooled upper respiratory specimens (nasopharyngeal, mid-turbinate, anterior nares or oropharyngeal swabs). **In clinical data presented by Quest to the FDA, none of 3,091 total specimens from a population with a prevalence rate of 1-10 percent, if pooled, would have been incorrectly determined to be negative (95%CI 0.0-0.1%).

The company expects to deploy the technique at its laboratories in Chantilly, VA and Marlborough, Mass., by the end of next week with additional laboratories to follow.

“As COVID-19 continues to spread around the country, access to timely, quality laboratory testing is critical to patients and an effective public health response,” said Steve Rusckowski, Chairman, CEO and President, Quest Diagnostics. “Pooled specimen testing is a proven technique that will help us to optimize testing capacity at this critical time for our country.”

“We applaud FDA for taking this important step to empower Quest to increase capacity across our national laboratory network,” said Jay G. Wohlgemuth, M.D., Senior Vice President and Chief Medical Officer, Quest Diagnostics. “Pooling will help expand testing capacity but it is not a magic bullet, and testing times will continue to be strained as long as soaring COVID-19 test demand outpaces capacity. Each of us can practice behaviors that will reduce COVID-19 infections in our communities, so our national healthcare system can better respond to this crisis.

FDA EUAs for Telemedicine Self-Collection
Yesterday, the FDA also granted three emergency use authorizations to Quest Diagnostics for the use of its Quest Diagnostics Self-Collection Kit with the Hologic Panther Fusion, Hologic Aptima and Roche cobas molecular platforms. The new EUAs expand the use of the self-collection kit beyond the EUA, granted on May 27th, for the use of the kit on the Quest SARS-CoV-2 rRT-PCR test. The company expects the new EUAs will allow it to use self-collection more broadly on behalf of clients and patients in the United States. Self-collected specimens that were not observed by a healthcare professional are not eligible for pooling.

About Quest Diagnosticsย 
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world’s largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals inย theย United States, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives.

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