Microport Neurotech Ltd.’s intracranial visualized stent Rebridge has been included in the green channel, a priority review for medical devices, by China’s NMPA. Read More
Rapidai Inc. received U.S. FDA 510(k) clearance for release of intracranial hemorrhage (ICH) triage technology that reduces notification fatigue in doctors swamped by calls to treat hemorrhages that turn out to be false positives. In a test sample sent to the regulatory agency, the artificial intelligence (AI)-powered system demonstrated a sensitivity rating of 97% detecting genuine hemorrhages and 100% specificity for a false positive rate of zero. Read More
After shelving it for the past decade, the EU Parliament this week adopted a directive forcing large publicly listed companies to break the glass ceilings that have allowed a men-only mentality to thrive in corporate boardrooms across much of Europe. The so-called Women on Boards Directive, formally adopted Nov. 22, will require EU-based public companies to have women in at least 40% of their nonexecutive director posts or 33% of all director posts by the end of June 2026. Companies with fewer than 250 employees will be exempt. Read More
The U.S. House of Representatives has resurrected the Pre-approval Information Exchange (PIE) Act, a bill that would bolster the prospects for drugs and devices by improving communications with payers prior to U.S. FDA clearance or approval of the product. The supporters of the legislation, a bipartisan group of members of the House Energy and Commerce (E&C) Committee, see the legislation as essential as a means of overcoming some of the ambiguities in a 2018 FDA guidance pertaining to communications between manufacturers and payers, and thus a replay of one of the more interesting methods of critiquing an FDA guidance. Read More
A combination of radiation therapy and CD47 blockade induced an abscopal effect in animal studies even in animals that lacked T cells, researchers reported in the Nov. 21, 2022, online issue of Nature Cancer. The findings are “the first demonstration of T-cell-independent abscopal response,” co-corresponding author Edward Graves told BioWorld. “We’re not trying to say that all abscopal responses are macrophage-mediated. There are plenty that require T cells,” Graves clarified. But “there is another avenue of abscopal responses that has not been reported. ... All the abscopal literature is about stimulating an adaptive response.”
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In an interview with BioWorld, Ceros Financial Services CEO Mark Goldwasser predicted significant changes in the financing market for med-tech companies in the coming year. While special purpose acquisition company (SPAC) deals are not anticipated to return to 2022 levels, Goldwasser expects “we’re going to see a lot of transactions out of big strategics” and a rally in the equity market in the first half of 2023. Read More
BioWorld's offices will be closed in observance of Thanksgiving in the U.S. No issues will be published Thursday, Nov. 24, or Friday, Nov. 25. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Empatica, Lucira Health. Read More
