Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3comma, Cagent, Dotmatics, Globus, Glucotrack, Neuropace, Nevro, Onetwo, Paige, Siemens.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Makani Science, Medivis.
Following news of U.S. President Donald Trump’s 10% across-the-board tariffs on Australian exports to the U.S., Australia’s Securities Exchange shed nearly AU$55 billion in losses Thursday morning. Even so, pharmaceuticals have escaped the tariffs for now. In China, Trump’s tariffs are not a big concern for China’s health care because drugs and active pharmaceutical ingredients are exempted from the tariffs. Even if tariffs are imposed in the future, Chinese pharmaceutical companies have already significantly de-risked themselves in recent months by increasing out-licensing models with U.S. partners.
At first glance, it appears that biopharmaceuticals dodged the latest U.S. tariff bullet; med-tech, not so much. According to the executive order President Donald Trump signed in the Rose Garden late yesterday, pharmaceuticals are one of the few things exempt from the new country-by-country reciprocal tariffs that will be going into effect over the next week. However, U.S.-based manufacturers of both drugs and devices could face supply chain disruptions, further market restrictions and increased operating costs as the new tariffs take effect and other countries retaliate.
Counterintuitively, use of cerebral embolic protection failed to reduce the incidence of stroke in the 72 hours following a transcatheter aortic valve replacement or implantation found a late-breaking clinical trial presented at ACC.25, the American College of Cardiology’s annual scientific session held March 29-31 in Chicago and simultaneously published in the New England Journal of Medicine.
CMR Surgical Ltd. secured more than $200 million in funding to bring its surgical robotic system, Versius, to the U.S. market and expand elsewhere. The financing, which came in the form of equity and debt, is “highly important” for the company and comes at the right time as it is “expanding and growing nicely,” company CEO Massimiliano Colella told BioWorld.
The renal denervation patent wars are now in full swing, with subsidiaries of Medtronic plc and Recor Medical LLC, landing the first blow in this chapter of the med tech patent struggles.
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) unveiled the pilot version of its AI Airlock in 2024, and the agency posted a list of the products that are taking part in this version of a regulatory sandbox.
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