Clinical updates, including trial initiations, enrollment status and data readouts and publications: Achiko, Angle, Biology Works, Moleculight, Neovasc.
Henley Ion Inc. is encouraged by early testing of a COVID-19 protection device. Henley’s Ion Virus Defender technology uses micronized electrostatic precipitation (mEP) to remove infectious bioaerosols from both inhaled and exhaled air. The company said initial tests of the prototype removed 99.8% of SARS-CoV-2 bioaerosols under Biosafety Level 3 testing conditions.
In a speech on Jan. 13, President Joe Biden revealed plans to purchase an additional 500 million at-home COVID-19 tests, bringing the total number the administration expects to provide for free to American households to 1 billion. In addition, Biden said the administration would distribute free “high quality masks.” On Wednesday, the administration said it would provide 5 million rapid COVID-19 tests and 5 million lab-based PCR tests to schools each month to support screening testing and test-to-stay programs.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) released guidance for sponsors and manufacturers on regulatory requirements for software to be used with COVID-19 rapid antigen self-tests that are intended to analyze and interpret tests results.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abiomed, Caredx, Castle Biosciences, Electrocore, Glaukos, Pictor.
The FDA reported a class I recall of the Wirion embolic protection device by Cardiovascular Systems Inc. (CSI), of St. Paul, Minn., due to reports of nine instances of device malfunction. The agency said the filter portion of the device can be difficult to withdraw under some circumstances and thus lead to separation, although the FDA noted that no deaths have been reported in association with the issue despite the risk of embolization. The FDA’s device center also posted a Jan. 11 notification against the use of two tests by Lusys Labs Inc., of San Diego, for the SARS-CoV-2 virus.
Where’s the plan? That was the underlying question Jan. 11 as Biden administration health officials faced frustration and tough questions from both Democrats and Republicans on the Senate Health, Education, Labor and Pensions (HELP) Committee about how the U.S. government is responding to the surge of COVID-19 infections caused by the omicron variant.
The epic rise and fall of Elizabeth Holmes, founder of Theranos Inc., will preoccupy the world of business for decades to come, but this story has also left a large footprint in the world of clinical diagnostics. David Stein, CEO of Babson Diagnostics Inc., of Austin, Texas, told BioWorld that investors are a bit more wary than usual because of the Theranos saga, forcing test developers to be more rigorous in test development and more transparent with investors about a test.
China’s med-tech products exports declined in 2021 as manufacturing in other countries picked up, while med-tech imports to the country increased. In the first half of 2021, China’s med-tech exports amounted to $47.931 billion, a decrease of 23.1% year-on-year. But imports for the same period amounted to $24.392 billion, an increase of 25.2% year-on-year, according to med-tech data company Guangzhou Joinchain Big Data Technology Co. Ltd.
Over the course of the past two years, two presidential administrations and the U.S. Congress have set considerable sums of money aside for testing for the COVID-19 pandemic, but reports of shortages of tests have prompted a response from Capitol Hill.
RSS
