Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clinical Enterprise, Fluidigm, Invo Bioscience, Memic Innovative Surgery, Mobidiag, Opgen, Perimeter Medical Imaging AI, Vascular Grafts Solutions, Vetex Medical.
A new study by Mayo Clinic and Nference Inc. researchers suggests that prior childhood and adult vaccinations for illnesses such as polio, measles and flu may provide protection against COVID-19 infection. The study, which analyzed patient data using Nference artificial intelligence (AI) software, underscores the critical role immunizations play in curbing the spread of diseases and preventing future pandemics. “What we discovered represents compelling evidence that vaccinations are a critical element in prevention of disease, even diseases one doesn’t anticipate,” said Venky Soundararajan, co-founder and chief scientific officer of the Cambridge, Mass.-based company.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aquarius Surgical Technologies, Healthmode, Htg Molecular Diagnostics, Inventiva, Materials and Machines, Medi-Tate, Mesa Biotech, Mind Medicine, Olympus, Picnichealth, Sirtex Medical, Surgical Lasers, Thermo Fisher, Vela Diagnostics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fusion Robotics, Roche.
Test developers and the U.S. FDA are scrambling to meet the testing needs of the American public, however, it's somewhat unclear what the agency's priorities are for the emergency use authorization (EUA) program. Jeffrey Shapiro, of Hyman Phelps & McNamara, made the case that the FDA’s Center for Devices and Radiological Health (CDRH) should be more transparent about its priorities for EUA review.
Adaptive Biotechnologies Corp. posted revenue of $30.2 million for the fourth quarter of 2020, up 25% from the corresponding prior year period. The tally beat consensus by $3.3 million. Clinical sequencing volume grew 41% to 4,539 clinical tests, compared with the fourth quarter of 2019. For the full year, revenue increased 16% year over year to $98.4 million, and clinical sequencing volume topped out at 15,216 clinical tests delivered, up 50%. The results coincided with the launch of the company’s T-Detect COVID, the first clinical T cell-based test to confirm recent or prior COVID-19 infection.
HONG KONG – Wuxi Diagnostic Investment (Cayman) Ltd. has raised $150 million in a series B financing round, while netting a number of new investors along the way. The new investors to come on board include Thermo Fisher Scientific Inc., Shiyu Capital, ABC International Holdings Ltd., Sunland Capital and CCBI Tech Venture.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: American Cryostem, Assure Holdings, Biotherapeutic Labs, Bird & Cronin, Caredx, Cerus, Charles River Laboratories, Clinical Reference Laboratory, Co-Diagnostics, Collplant Biotechnologies, Dynatronics, Grin, Henry Schein, Icon, Illumina, Imaging Endpoints, Intalere, Kibur Medical, Neovasc, New England Biolabs, Oxford Nanopore Technologies, Patientslikeme, PRA Health Sciences, Protembis, Puretech Health, Renalytix AI, Rubiconmd, Sentry Neuromonitoring, Shandong Zhongbaokang Medical Implements, Siren Care, Smiledirectclub, SQN Clinical, Transchart, TX Services, United Therapeutics, Veristat, Walgreens.
CAJICA, Colombia – Three countries have emerged as the key engines of growth for Latin America’s medical devices sector, accounting for the largest share of exports and investment in the space across the region and experiencing growth over the past decade that may have been supercharged by the COVID-19 pandemic.