3M, of St Paul, Minn., said it is planning to initiate restructuring actions that will impact all business groups, functions and geographies. The restructuring is expected to affect about 2,900 positions globally.
Santa Clara, Calif.-based Agilent Technologies Inc. said that its clinical informatics platform Alissa Interpret has been adopted by the North West Genomic Laboratory Hub based in Manchester and Liverpool, part of Manchester University NHS Foundation Trust, England.
Tel Aviv, Israel-based Aidoc and Imbio, which has a presence in Minneapolis and Delafield, Wis., reported a partnership intended to provide the world's first end-to-end artificial intelligence solution for pulmonary embolism, with the goal of improving efficiency and quality of pulmonary embolism detection and treatment.
Foster City, Calif.-based Arena Solutions reported a new partnership with Boston-based Medicept Inc., a medical device and in vitro diagnostic compliance consulting firm. This partnership combines Arena's quality management system solutions with complementary quality management, regulatory and engineering support from Medicept.
Atcc, of Manassas, Va., reported the introduction of its new SARS-CoV-2 External Control Kit for clinical laboratories and test manufacturers.
San Diego-based Axim Biotechnologies Inc. reported the development of an enzyme-linked immunosorbent assay -based diagnostic test for the detection of SARS‐CoV-2 neutralizing antibodies.
Bioaesthetics Corp., of Research Triangle Park, N.C., reported that a clinical study of its nipple reconstruction graft will be performed at Stanford Medicine beginning in 2021.
Biofourmis, a Boston-based company focused on digital therapeutics and virtual care that powers personalized predictive care, reported the national rollout of Biovitals Hospital@Home, an artificial intelligence-based, turnkey technology platform that enables hospitals and health systems to quickly deploy a "hospital at home" program.
Hauppauge, N.Y.-based Chembio Diagnostics Inc. said it won a contract from the Biomedical Advanced Research and Development Authority (BARDA), which is part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. The contract will support the development and pursuit of U.S. FDA emergency use authorization (EUA) for a rapid, multiplex DPP Respiratory Antigen Panel point-of-care test system using Chembio’s DPP technology for the upcoming flu season. The contract also supports preparation of a submission in pursuit of 510(k) clearance for the rapid DPP SARS-CoV-2 Antigen test system that was recently submitted to the FDA for an EUA. The award totals $12,691,726.
Clinical Ink Inc., of Horsham, Pa., reported an investment from San Francisco-based Mckesson Ventures, the venture capital firm backed by Mckesson Corp., alongside the debut of its Lunexis Epro+ solution. The new tool is part of a unified technology platform that streamlines implementation processes and allows patients and sites to choose how they want to participate in a clinical study. The companies did not disclose the size of the investment.
Dysis Medical Inc., of Alpharetta, Ga., said the U.S. Centers for Medicare and Medicaid Services (CMS) issued its 2021 Medicare Physician Fee Schedule that now includes reimbursement rates for Add-On CPT Code 57465 (computer-aided mapping of cervix uteri during colposcopy, including optical dynamic spectral imaging and algorithmic quantification of the acetowhitening effect) under which Dysis Smart Colposcopy with Dysismap is billed.
Menlo Park, Calif.-based Drawbridge Health and the Medical Research Council Epidemiology Unit, University of Cambridge in the U.K., reported the use of the Onedraw Blood Collection Device for remote blood sample collection in a large-scale surveillance study currently being conducted to assess the prevalence of previous infection with COVID-19. The study, which was launched in July and has recruited 4,000 participants, aims to quantify the proportion of people who have been previously infected with COVID-19 in the Fenland cohort, which is broadly representative of the population of Cambridgeshire.
Endra Life Sciences Inc., of Ann Arbor, Mich., said that Centre Hospitalier Universitaire d’Angers, France, is partnering with the company for a clinical study of its Thermo Acoustic Enhanced Ultrasound (TAEUS) device for assessing non-alcoholic fatty liver disease (NAFLD). The study will compare TAEUS liver device against a baseline of liver fat as determined by the current standard of care, MRI-PDFF (proton density fat fraction), provide Endra with clinical feedback on product design and clinical performance, and aid in establishing the clinical value proposition of the TAEUS system in NAFLD to support ongoing commercialization efforts.
Haliodx SAS, of Marseille, France, said its Immunoscore is being assessed in a new study with two cohorts from the prospective, randomized IDEA international trial in stage III colorectal cancer: the SCOT cohort in the U.K. and the HORG cohort in Greece. The new study aims to consolidate results obtained in the Immunoscore-IDEA France study for its predictive and prognostic performance in additional independent studies. It also will investigate Immunoscore performance in patients treated with CAPOX, a chemotherapy regimen combining capecitabine and oxaliplatin. The study will be conducted in 3,000 patients receiving either FOLFOX (leucovorin calcium, fluorouracil and oxaliplatin) or CAPOX chemotherapy.
Cupertino, Calif.-based Huami Corp. and Promaxo Inc., of Oakland, Calif., are partnering for joint technology, commercialization and market development opportunities. Under the arrangement, Promaxo plans to leverage Huami’s wearable technology to explore potential improvements in pre- and post-treatment patient health and behavior. Huami is also exploring potential investment in Promaxo.
Tel Aviv-based Ibex Medical Analytics Ltd. and Institut Curie in Paris are partnering to improve artificial intelligence (AI)-powered breast cancer detection. The research collaboration will include a rich dataset of breast biopsy slides, digitized using a digital pathology scanner and analyzed for cancer detection using Ibex’s Galen Breast solution. Independently, multiple pathologists from Institut Curie will diagnose the slides, followed by blinded analysis of the AI solution’s performance. The solution is already deployed at the pathology institute of Maccabi Healthcare Services in Israel, where it is used as a second read application.
Los Angeles-based Intrivo Diagnostics Inc. said it has inked national distribution agreements with Concordance Healthcare Solutions LLC, of Tiffin, Ohio, and NDC Inc. (National Distribution & Contracting), of Tennessee, for Carestart COVID-19 tests made by Access Bio Inc., of Somerset, N.J. To date, Access Bio has received U.S. FDA emergency use authorization for its RT-PCR test, IgM/IgG antibody test and a rapid point-of-care antigen test.
Lantheus Holdings Inc., of Billerica, Mass., has agreed to sell its Puerto Rico radiopharmacy and positron emission tomography (PET) manufacturing facility to Boca Raton, Fla.-based Pharmalogic Holdings Corp. for $18 million in cash. As part of the stock purchase agreement, Lantheus and Pharmalogic will enter a long-term supply agreement whereby Lantheus will continue to supply Pharmalogic with its products and Pharmalogic will commit to purchase certain products. The deal is expected to close early in the first quarter of 2021.
Meridian Bioscience Inc., of Cincinnati, said it has launched an Air-Dryable RT-qPCR Mix, driving innovation in the development of molecular tests with ambient temperature stability.
Fruitport, Mich.-based Motion Dynamics LLC, a portfolio company of Vance Street Capital, has acquired Viamed Holdings LLC, a manufacturer of custom, micro and precision components and subassemblies for the medical device industry headquartered in Morrisville, N.C. The transaction marks the first strategic add-on acquisition for Motion Dynamics. Financial terms were not disclosed.
Natera Inc., the San Carlos, Calif.-based provider of the genetic screening test Panorama, said that the two largest commercial health plans in the U.S. have extended coverage of noninvasive prenatal tests (NIPT) to all pregnancies. The company now estimates that more than 90% of all commercially covered individuals will have average risk NIPT coverage.
Neuroone Medical Technologies Corp., of Eden Prairie, Minn., reported the first commercial use of its Evo Cortical Electrode at the Mayo Clinic in Rochester, Minn. In addition to recording a seizure, the Neuroone electrodes also recorded evidence of preseizure activity.
Physitrack Ltd., of London, launched an in-house M&A program that targets the acquisition of companies in the digital health space. The company also reported the acquisition of Tampere, Finland-based Physiotools OY, along with Göteborg, Sweden-based Mobilus Digital Rehab AB, a wholly owned subsidiary of Physiotools, for an unreported amount. The acquisition combined cash and shares as consideration and closed Nov. 30, 2020.
Seoul, South Korea-based Seegene Inc. said the extraction-free application of the Allplex SARS-CoV-2/FluA/FluB/RSV Assay is now available in Europe.