Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Circa Scientific, KSL Diagnostics, SQI Diagnostics.
The FDA continues its tight surveillance of rapid antigen tests for the COVID-19 pandemic and has issued three safety communications advising against the use of these tests thus far in the month of March. In each instance, the test is made by the manufacturer of name, but was not authorized in the U.S., making these misbranded products despite their legal use in other nations.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dexcom, Gleamer, Intrivo, J&J Vision, Valencia Technologies.
New drug and device regulations going into effect in Canada are serving as a reminder of the extended life of the COVID-19 pandemic. After two years of interim orders regulating the importation and sale of drugs and devices for COVID-19 clinical trials and the conduct of those trials, Canada is issuing long-term regulations that will incorporate most of the provisions of the temporary orders.
Visby Medical Inc. reeled in more than $100 million in a series E round led by Ping An Voyager Partners. The funds will be used to scale production capacity of Visby’s instrument-free, single-use real-time polymerase chain reaction (RT-PCR) platform from tens to hundreds of thousands of tests per month.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chromacode, Dyad Medical, Medtronic.
LONDON – Oxford University spinout Oxdx Ltd. has raised £2.6 million (US$3.6 million) in pre-seed funding to advance development of a technology for directly identifying infectious pathogens without the need to purify, culture or amplify samples first. The instant testing method uses a mixture of a single universal reagent, high resolution microscopy and machine learning, to identify specific species and strains of bacteria, viruses and other pathogens within minutes.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Foundation Medicine, Gramercy Extremity Orthopedics, Lumiradx, Olympus, Precisis.
The Biden administration has posted a request for information (RFI) about the conditions necessary for the in vitro diagnostic industry to sustain testing capacity for communicable disease outbreaks, although the letter commits to no specific actions. The Advanced Medical Technology Association responded to the RFI with the recommendation that the administration quickly commit to the provision of resources as a means of ensuring that “market volatility will no longer determine test availability.”
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