COPENHAGEN, Denmark, April 28, 2026 /PRNewswire/ — 3Shape today announced that the U.S. Food and Drug Administration (FDA) has granted FDA clearance for its Dx Software following a review completed on April 10. 2026.
IRVINE, Calif., April 28, 2026 /PRNewswire/ — Laguna Diagnostics, LLC today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company’s mRNA Gene Biomarker Test, a novel blood-based test designed to aid in the differentiation of schizophrenia and bipolar I disorder in symptomatic patients.
BURLINGTON, Mass., April 28, 2026 /PRNewswire/ — SQ Innovation, developer of Lasix® ONYU, today announced two important regulatory milestones in its international expansion strategy: the receipt of a CE marking certificate for the Lasix ONYU device, and the acceptance of Lasix ONYU by the European Medicines Agency (EMA) for review under the centralized procedure on the basis of technical innovation. Together, these milestones represent a significant step forward in bringing this novel at-home subcutaneous furosemide treatment to patients in Europe and other international markets.
Motif Neurotech announced today that it received FDA investigational device exemption (IDE) to evaluate its brain stimulation implant.
Tandem Diabetes Care (Nasdaq:TNDM) today announced FDA clearance for its automated insulin delivery (AID) technology for use in pregnancy.
Pixee Medical announced today that it received FDA 510(k) clearance for its Knee+ NexSight augmented reality (AR)-based solution.
Vanderbilt researchers led by Xiaoguang Dong, assistant professor of mechanical engineering, have developed a novel device that can be used remotely to continuously monitor the airway stents of patients with diseases like lung cancer.
NEW YORK, April 27, 2026 /PRNewswire/ — TytoCare, a virtual care company enabling accessible, high-quality primary care from home, today announced it has received FDA De Novo classification for the first model of Tyto Insights™ for ENT Suite, marking the creation of a new regulatory category for AI-powered ENT image analysis.
The King’s College London team tested the wool-based keratin in animal models and found the material was able to guide new bone growth across damaged areas.
Medtronic (NYSE:MDT) today announced new milestones for its Affera family of technologies, including FDA breakthrough device designation.