An artificial intelligence (AI) algorithm developed by Geisinger researchers that uses echocardiogram videos predicted all-cause mortality at one year more accurately than three out of four expert cardiologists and other predictors commonly used in clinical practice, a study in Nature Biomedical Engineering demonstrated. Read More
The U.S. FDA has granted breakthrough device designation to Cerus Endovascular Ltd. for its Contour neurovascular system for the treatment of intracranial aneurysms. The company is targeting the second or third quarter of this year for the start of its IDE clinical trial. Read More
Laboratory Corporation of America Holdings (Labcorp) reported its financial performance for the fourth quarter of 2020, which included a jump in revenues of 52%, a result enabled in part by its quick response to the COVID-19 pandemic. However, Labcorp said that revenues related to pandemic testing could decline by anywhere from 35% to 50% over the course of calendar year 2021. Read More
LONDON – The EMA has requested all COVID-19 vaccine developers to investigate if their products offer protection against new variants of SARS-CoV-2 and to submit the relevant data. Read More
It’s been more than a year since COVID-19 initially smacked humanity and as BioWorld’s senior analyst, Karen Carey, detailed in early February, vaccine and therapeutic R&D continues to move furiously forward. Variants have added a new twist in the race to gain global control of the virus. But what about tests and surveillance? Are these medical technologies keeping pace with the rapidly changing virus? BioWorld MedTech takes a deep dive in today’s edition.
Staff Writer Meg Bryant looks for answers on whether current tests are effective when it comes to the variants and how the test makers are adapting.
Staff Writer Annette Boyle explores how industry and universities united to scale up surveillance of SARS-CoV-2 variants.
Senior Science Editor Anette Breindl explains why mutations in SARS-CoV-2 are at once a challenge, a fact of life and an opportunity.
Regulatory Editor Mark McCarty highlights how governments are being challenged with keeping track of mutations while simultaneously validating new and revamped existing tests.
As COVID-19 variants have emerged, so have questions about the effectiveness of tests for infection. While the risk of mutations significantly limiting their ability to detect the novel coronavirus is thought to be relatively low, companies that make COVID-19 tests are moving quickly to enhance and revalidate their products. Read More
By mid-January 2021, the U.K., South Africa and Brazil had confirmed that “variants of concern” were driving massive surges in COVID-19 cases in their countries. Once alerted, other nations found these troubling strains rapidly multiplying within their populations as well. At the time, the world had reported 90 million cases, creating abundant opportunities for the coronavirus to mutate. Of those cases, the virus in just 360,000 had been sequenced – and nearly all of them from just a handful of countries. Read More
As of the end of January, SARS-CoV-2 has demonstrably infected more than 100 million individuals globally. It has killed more than 2 million. And the long-term sequelae of COVID infections – to say nothing of the health consequences of grief, social isolation and widespread economic distress – are still unfolding and will be for years to come. Read More
Governments across the globe are struggling to keep pace with the SARS-CoV-2 virus’s impact on public health, but the new variants are presenting their own challenges. The next task facing governments across the globe is to sequence the latest mutated variants of the virus and keep track of any further mutations, all while validating new and revamped existing tests, a task that is likely to prove difficult to meet for at least the next few months. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Binovi Technologies, Bioiq, Biomeme, Bio-Techne, Dermtech, Electrocore, Eurofins, Flatiron Health, Fluidigm, Foundation Medicine, Gatc Health, H3 Biomedicine, Integrated Operations, Medalliance, Mosaic Surgical, Sport Orthèse, Planyx, Zymo Research. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Access Vascular, Braincool, Brainq, Cerus Endovascular, Genscript, Limacorporate, Roche, Techmah Medical. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MITA announces new health care supplier standard; Laggardly patient record response costs provider $75k; New med-tech resource platform now includes logistics; Spectrascience the subject of speculation, SEC action; HC nudging along with regulatory modernization plan. Read More
Keeping you up to date on recent developments in diagnostics, including: Prostate cancer risk scores; Predicting phase separation; iPSCs give sneak preview of AML. Read More
