Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Airos Medical, GE Healthcare, Gynesonics, Quest Diagnostics.
The impact of COVID-19 is being felt at the American Society of Clinical Oncology (ASCO) annual meeting as much as anywhere else, typically held at McCormick Place in Chicago but this year conducted virtually because of the pandemic.
The number of tests of various types for the SARS-CoV-2 virus are still growing, but the emergency use authorization (EUA) program is not the only option for developers. Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiology, said on the agency’s May 27 town hall that the agency would like to see test developers file for a 510(k) for their tests when the data are sufficient to support an application, adding that any such clearances will not affect the U.S. FDA’s interest in keeping plenty of similar tests on the market via the EUA mechanism.
Within a month of disclosing a CA$175.6 million (US$124.7 million) award from the Canadian government to use its antibody discovery platform for the analysis of patients who have recovered from COVID-19, Abcellera Biologics Inc. closed a $105 million series B financing aimed at expanding its capacity and investing in new technologies that complement its antibody discovery engine.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott Laboratories, Biotricity, Capsule Technologies, EKF Diagnostics, Indica Labs, Kings College London, Longhorn Vaccines and Diagnostics, Medisana, Meditemi, Octo, Oncimmune Holdings, Open Pathology, Opencell, Opentrons, Orthogenrx, Sherlock Biosciences, Sinai Health System, Somatix, Sunquest Information Systems, Temi, Transenterix, Varian, Vayyar.
The U.S. Department of Health and Human Services (HHS) has posted a national COVID-19 testing strategy in response to legislation passed in April, and the plan suggests that 300,000 tests per day should suffice to corral the pandemic. That calculation drew immediate fire from House and Senate Democrats, who characterized the plan as an attempt “to paint a rosy picture about testing,” but they also pushed the Senate to pass House legislation that would provide another $75 billion in funding for testing and contact tracing.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4DMedical, Bardy Diagnostics, Beyond Air, Merit Medical, Orteq Sports Medicine, Philips, Smart Medical Systems, United Imaging.
