MedTech News
.................... by Andrew Celentano
Lasix® ONYU[1] Achieves CE Marking under EU Medical Device Regulation
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 wins FDA IDE to evaluate brain implant for treating depression
Motif Neurotech announced today that it received FDA investigational device exemption (IDE) to evaluate its brain stimulation implant.
Tandem wins FDA clearance for automated insulin delivery in pregnant women with type 1 diabetes
Tandem Diabetes Care (Nasdaq:TNDM) today announced FDA clearance for its automated insulin delivery (AID) technology for use in pregnancy.
Pixee wins FDA nod for next-gen AR knee surgery tech
Pixee Medical announced today that it received FDA 510(k) clearance for its Knee+ NexSight augmented reality (AR)-based solution.
Battery-free airway device could spot stent complications early through remote monitoring
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.
TytoCare Secures FDA De Novo for First AI-Powered Eardrum Analysis
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.
Scientists transform wool into bone repair material
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 wins FDA breakthrough nod for Sphere-9 catheter, reports new clinical milestones for Affera
Medtronic (NYSE:MDT) today announced new milestones for its Affera family of technologies, including FDA breakthrough device designation.