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Australia’s Therapeutic Goods Administration is conducting a postmarket review of all COVID-19 point-of-care and laboratory tests listed in the Australian Register of Therapeutic Goods to ensure that they can detect emerging SARS-CoV-2 genetic variants. Read More
Health Canada has issued new guidance for devicemakers on submitting “summary reports” and conducting issue-related analyses of safety and effectiveness for devices approved for marketing in Canada — two requirements recently added to Canadian regulations. Read More
The San Diego, Calif., company focuses on developing novel cell replacement therapies based on cell encapsulation and implantation devices, and cell replacement therapies derived from pluripotent stem cells. Read More
The handheld device directs precise wavelengths of targeted light to the back of the throat and surrounding tissues and is designed for at-home treatment of mild-to-moderate COVID-19 in adult patients. Read More
“The FDA has determined that it is appropriate to protect the public health or safety to revise certain decontamination system EUAs to limit the number of decontamination cycles and respirator reuses permitted under each authorization,” the agency said. Read More
The new clearance allows the implant, which is used by surgeons to reconstruct cranial and facial bones, to be used with post-operative ultrasound imaging. Read More
The mobile air filter is designed for use in locations such as acute care areas, contaminated storage and handling areas, and in long-term healthcare facilities. Read More