MedTech News
Rain Eye Drops Launches First-Ever Dispenser Aid for Single-Use Eye Drops
Innovative Device Enhances Ease, Precision, and Accessibility for Patients Using Preservative-Free Eye Medications
InspireMD launches carotid stent in U.S. after FDA approval
InspireMD (Nasdaq:NSPR) announced today that it launched its CGuard Prime carotid stent in the U.S. after receiving FDA premarket approval (PMA) last month.
Aktiia’s Hilo Band Becomes First Cuffless Blood Pressure Monitor Cleared by FDA for Over-the-Counter Use
NEUCHÂTEL, Switzerland, July 9, 2025 /PRNewswire/ — Aktiia, a pioneer in optical blood pressure monitoring, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for over-the-counter (OTC) use of its cuffless blood pressure monitoring technology.
Exactech Announces FDA Clearance of First-to-Market Scapula Reconstruction System for Acromial Stress Fractures
GAINESVILLE, Fla., July 9, 2025 /PRNewswire/ — Exactech, a global medical technology leader, announced the Equinoxe® Scapula Reconstruction System for acromial and scapular spine fractures has received 510(k) clearance1 from the U.S. Food and Drug Administration, marking a significant advancement in the treatment of acromial and scapular spine fractures.
Implantable device could save diabetes patients from dangerously low blood sugar
The new implant carries a reservoir of glucagon that can be stored under the skin and deployed during an emergency — with no injections needed.
AIRS Medical Earns Expanded MDR Certification for AI-Powered MRI Image Enhancement Solution SwiftMR™
SEOUL, South Korea, July 8, 2025 /PRNewswire/ — AIRS Medical, a leader in AI solutions for diagnostic imaging, has received Medical Device Regulation (MDR) certification from the European Union (EU) for SwiftMR across all body parts. This expanded certification facilitates broader clinical use of SwiftMR in Europe — giving providers new tools to care for a wider range of patients.
Fziomed Gains FDA De Novo Classification Grant and Marketing Authorization for Oxiplex® Gel in Spine Surgery
Oxiplex is the only FDA authorized intraoperative gel indicated as an adjunct to lumbar spinal surgery to reduce postoperative leg pain and neurological symptoms.
LED-based imaging system could transform cancer detection in endoscopy
Gastrointestinal cancers remain among the most common forms of cancer. While endoscopy has become a cornerstone of cancer screening and diagnosis over the past two decades, the procedure still misses approximately 8% to 11% of tumors, due to visibility limitations. Now, researchers have developed a prototype imaging system that could significantly improve doctors’ ability to detect cancerous tissue during endoscopic procedures.