Spectral MD Holdings Ltd. has delivered stark evidence of the need for its Deepview wound imaging system, in a study showing that medics in emergency rooms making initial judgments on the severity of burns were accurate only in 74% of cases. The critical feature is the depth of a burn.
Rainmed Medical Ltd.'s coronary angiography-derived fractional flow reserve system (caFFR system) was approved by Australia’s TGA for precision diagnosis of coronary artery diseases.
The White House laid out several timelines Oct. 18 as part of a national biodefense strategy for countering biological threats and enhancing global pandemic preparedness.
Three months after agreeing to an intellectual property waiver for COVID-19 vaccines, World Trade Organization (WTO) members are discussing expanding it to therapies, diagnostics and devices used in preventing, diagnosing and treating COVID-19 infections.
The 2022 Albert Lasker Basic Medical Research Award has been awarded to Richard Hynes, of the Massachusetts Institute of Technology, Erkki Ruoslahti, of the Sanford Burnham Prebys Medical Discovery Institute, and Timothy Springer, of Harvard Medical School “for discoveries concerning the integrins, key mediators of cell-matrix and cell-cell adhesion in physiology and disease.”
Recognizing that academic sponsors and nonprofits are major contributors to the development of advanced therapy medical products (ATMPs) and diagnostic and delivery devices, the EMA is launching a pilot program to help them navigate the challenging regulatory requirements in the space.
The University of Texas MD Anderson Cancer Center and Radiopharm Theranostics Ltd. have launched Radiopharm Ventures LLC, a joint venture (JV) that will develop radiopharmaceutical therapies for cancer. Radiopharm Theranostics owns 51% of shares in the new entity, while MD Anderson owns 49%.
From the beginning of the monkeypox outbreak in the U.S. in May, the federal government has bungled the response, according to both Democratic and Republican members of the Senate Health, Education, Labor and Pensions (HELP) Committee.
With a goal of manufacturing biotechnology in the U.S. that’s invented in the U.S., President Joe Biden signed an executive order Sept. 12 launching a National Biotechnology and Biomanufacturing Initiative that’s intended to strengthen the country’s bioeconomy, build stronger supply chains, and better utilize and secure biological data.
An administrative law judge has decreed that the acquisition of Grail Inc., by Illumina Inc., would not represent a suppression of competition in the market for multicancer early detection (MCED) tests, clearing a way for an acquisition that was initially valued at more than $7 billion.
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