The Dec. 9, 2019, FDA draft guidance spelling out performance criteria for magnetic resonance coils seemed to take up a relatively simple matter, but industry’s response suggested otherwise. The Medical Imaging & Technology Alliance (MITA) recommended that the agency undertake nearly two dozen changes to the draft, including a change to the title to indicate that the scope of the guidance is limited to receive-only MRI coils.
HONG KONG – A team of researchers at Hong Kong University of Science and Technology (HKUST) claim to have invented the world’s fastest portable 2019-nCoV diagnostic device. From sampling to testing, the device is apparently able to detect the novel coronavirus in just 40 minutes. In comparison, the polymerase chain reaction (PCR) technology that is currently in use can take between 1.5 to 3 hours. The device draws on the latest microfluidic chip technology from Shenzhen Shineway Hi-Tech Co. Ltd.
Keeping you up to date on recent developments in diagnostics, including: Raman spectroscopy to monitor blood glucose; A score to predict progressive chronic liver disease; From African genomes, big insights with small sample size.
With an eye toward expanding the reach of its Febridx rapid point-of-care (POC) test, Lumos Diagnostics Holdings Pty. Ltd. has seen the closing of a $15 million series A round from Australia’s Planet Innovation. The funds will back a U.S. FDA pivotal clinical trial, as well as additional development and manufacturing resources for the company’s expanding full-service POC business.
The U.S. Department of Health and Human Services has declared a public health emergency in the U.S. over the coronavirus in part because a government diagnostic for the virus yields inconsistent results, a fact that may spur the life sciences to provide a solution.
The U.S. Department of Health and Human Services has declared a public health emergency in the U.S. over the coronavirus in part because a government diagnostic for the virus yields inconsistent results, a fact that may spur the life sciences to provide a solution.
As the deadly coronavirus continues to spread, countries around the world are scrambling to understand the public health threat and identify and quarantine people who may be infected. To that end, Novacyt SA has launched a molecular test that detects only the 2019 strain of the coronavirus, reducing the chance of false diagnoses.
HONG KONG – Singapore molecular diagnostics group Inex Innovate Pte. Ltd. has inked a deal to have its in-vitro diagnostic (IVD) kit for the detection of ovarian cancer distributed in Taiwan. The value of the deal with the New Taipei City, Taiwan-based electronics and med-tech distributor Inalways Corp. is subject to annual minimum order quantities and milestones in relation to regulatory approvals.
Heartflow Inc., of Redwood City, Calif., is working on two Medicare administrative contractors (MACs) to cover its functional flow reserve algorithm for the coronary arteries, but Heartflow’s Heather Brown told BioWorld that said that the existing local coverage policies fall far short of the cost of the service, thus impeding beneficiary access.
PARIS – The European mammography division of GE Healthcare Inc., based in Buc, France, has just performed the first breast biopsy guided by angiomammography, using the Pristina Serena biopsy robot on a patient at the Gustave Roussy Institute in Villejuif, France.
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