Widespread testing is going to be key to safely reopening businesses and global economies in the current pandemic. To that end, Kahala Biosciences LLC, an Irvine, Calif.-based testing and tracking startup, and its technology partner, Rymedi Inc., of Greenville, S.C., have launched the Adiona COVID-19 antibody testing platform, combining antibody testing with a blockchain-enabled smartphone app to increase predictability and traceability of potential outbreaks.
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.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Nantong Egens Biotechnology, Ntbio Diagnostics.
Amsterdam-based Royal Philips NV has launched a five-day, wearable biosensor patch that monitors respiratory and heart rates once every minute, as well as assesses contextual information such as posture, activity level and ambulation. The wearable, disposable patch, dubbed the Philips Biosensor BX100, has received FDA clearance and a CE mark and is intended for use in lower acuity hospital care.
As the FDA continues to shift its limited resources to the development and review of COVID-19 therapies and vaccines, other drugs in the pipeline may be delayed. In a question-and-answer guidance released late Tuesday, the agency acknowledged that, going forward, it may not be able to sustain its current performance level in meeting all its goal dates for new drugs and biologics.
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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Amivas, Anivive, Astellas, Azitra, Beyond Air, BMS, Diffusion, Fresenius Kabi, GSK, Immunitybio, Intelgenx, Microbion, Protara, Radius, Regenerx, Regeneron, Relmada, Sanofi, Sorrento.
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.
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