About five months after the U.S. FDA disclosed its roadmap to move away from animal testing in favor of new approaches for biopharma drug development, the U.S. National Institutes of Health (NIH) said it is awarding $87 million in contracts over three years to launch the Standardized Organoid Modeling Center.
The Trump administration has launched an investigation into the national security effects of imports of medical equipment, devices, consumables and equipment, laying the groundwork for a potential increase in tariffs targeting the industry. A separate investigation into robotics and industrial machinery began the same day. Med-tech stocks dropped significantly in response to the news as investors fear increased tariffs on the sector. In April, the administration initiated a similar review of the pharmaceutical industry and in August threatened 200% tariffs on that sector.
The U.S. FDA issued a pair of final guidances this week, including one that outlines the criteria for authorizing emergency use of unapproved in vitro diagnostic tests during future public health emergencies and another on software assurance in computer and data processing systems for medical device production.
Kent Imaging Inc. received CE marking for its SnapshotNIR imaging device which uses near-infrared spectroscopy to measure oxygenated and deoxygenated hemoglobin in the microvasculature. The non-invasive point-of-care device provides real-time data to clinicians to help them make decisions which can change the trajectory of a wound, from chronic and non-healing, into a healing one, significantly improving the patient’s quality of life.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3DR Labs, Avant Technologies, Cleerly, Dariohealth, Elidah, Femasys, Femselect, Glooko, Iotamotion, Koios, Monarch Medical, Philips, Ramsoft, Seastar.
The struggle to avoid a partial U.S. government shutdown at midnight Sept. 30 is getting a lot of attention, as the stakes increase every day of the political standoff. Meanwhile, Sept. 30 also could be the end of the 43-year-old Small Business Innovation Research (SBIR) program, which has been a funding boon for biotech and med-tech startups, if Congress can’t come together on a reauthorization bill.
Sonomind SAS raised €3 million (US$ 3.5 million) in financing for its transcranial neuromodulation system, which targets deep regions within the brain non-invasively. The funds will go towards accelerating the development of the platform, which has already proven to be safe and effective in treating patients suffering from drug-resistant depression, after only five days of treatment.
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