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- CERTIFICATIONS

Rapid Nexus Becomes the First Company to Receive FDA Clearance for its Advanced Wound-Healing Device Hemastyl

BREA, Calif., Nov. 13, 2025 /PRNewswire/ — Rapid Nexus Nanotech Wound Solutions, Inc., a California-based med-tech company focused on advanced wound care, today announced it has received FDA 510(k) clearance for its Hemastyl gel device—marking a historic milestone as the first company to directly target the underlying reason chronic wounds fail to heal.

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Hubly Surgical Auto-Stop Drill Receives FDA 510(k) Clearance for Spinal Decompression Surgery: Laminectomy and Laminotomy

LISLE, Ill., Nov. 12, 2025 /PRNewswire/ — Hubly Surgical today announced FDA 510(k) clearance expanding Hubly Auto-Stop Drill indications to include spinal decompression procedures. To date, many thousands of neurosurgical patient lives have been saved using Hubly Auto-Stop Drills; the device’s SMART auto-stop halts rotation and prevents forward plunge at the instant of skull penetration, preventing over-drilling into patients’ brains. The new clearance expands use to laminectomy and laminotomy for spinal decompression to drill through the vertebral lamina and protect patients from damage to the spinal cord.

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MedCAD’s AccuStride™ Fixation Plates Receive 510(k) FDA Clearance to Complete Foot and Ankle System Offering

DALLAS, Nov. 6, 2025 /PRNewswire/ — Dallas-based MedCAD has been awarded 510(k) FDA clearance for its AccuStride fixation plates, part of a patient-specific solution available to surgeons as a complete foot and ankle (F&A) system. The company received 510(k) FDA clearance for its foot and ankle guides and planning system in March 2025. The AccuStride implant and surgical guide system coupled with the company’s proprietary planning software will enable foot and ankle surgeons to correct multiple related pathologies in a single procedure.

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Nitinotes Receives CE Mark Approval of EndoZip™, the First Fully Automated Suturing System for Endoscopic Sleeve Gastroplasty

CAESAREA, Israel, Nov. 6, 2025 /PRNewswire/ — Nitinotes Ltd., a medical device company transforming the treatment of obesity, today announced it has received CE Mark approval for the EndoZip™ System, the first fully automated suturing platform for endoscopic sleeve gastroplasty (ESG). The milestone clearance enables Nitinotes to begin commercialization across the European Union and other CE Mark-accepting markets.

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