The FDA’s Center for Devices and Radiological Health (CDRH) will have its hands full with the roll-out of the overhauled quality management regulation, but this will have ripple effects on industry as well. Keisha Thomas, associate director for compliance and quality at CDRH, told an audience in Washington DC that risk management will be a big focus in FDA oversight and inspections in 2026, a point of emphasis that could lead to more routine compliance and enforcement action.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: BTT, BTT Medical Institute, Dariohealth, Delcath, Endra, Famenity, Owkin, Sunbird Bio.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acupath, Alerje, Euroimmun, GE Healthcare, Mirus, Radiomedix, Revvity, Sempresto, Thor Medical, Valar, Vialase, Volitionrx, Zoll Medical.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axogen, Catalyst Orthoscience, Insulet, MED-EL, Medtronic, Wingderm Electro-optics.
Shares of Cosmo Pharmaceuticals NV rose sharply on Dec. 3 following top-line pivotal phase III data showing a statistically significant and clinically meaningful improvement in male androgenetic alopecia patients receiving clascoterone 5%, the first topical androgen receptor inhibitor, which uses the same active ingredient as the company’s acne treatment, Winlevi.
After raising more than twice as much as expected in its March IPO, Kestra Medical Technologies Inc. appears poised to repeat its success with an upsized secondary offering as well. The Kirkland, Wash.-based company initially planned to offer 5.5 million shares in its second pass at the market but increased the number of shares to 6 million two days later when it set the price at $23 per share. The projected gross proceeds of $138 million provide a nice addition to the $232 million raised nine months ago.
Ireland’s life sciences and health tech companies raised a record-breaking €491.3 million ($572.9 million) in venture capital funding across 89 deals in 2024, according to a report from Enterprise Ireland. The investment underscores investor confidence in the country’s ecosystem, which looks set to continue despite global headwinds such as trade tariffs, economic uncertainty and rising operating costs.
Sen. Bill Cassidy, R-La., who chairs the Senate Health, Education, Labor and Pensions Committee, released another letter to the American Medical Association regarding the activities of the AMA committee for CPT coding activities.
Brainomix Ltd. reported the publication of a prospective real-world study demonstrating that its AI imaging platform, Brainomix 360 Stroke, significantly increased rates of endovascular thrombectomy (EVT) treatment, a minimally invasive surgical procedure for patients with large vessel occlusion stroke, and reduced delays in patient triage and transfer.
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