Dror Ortho-Design advances U.S. commercialization with next-generation ZSmile Platform
Dror Ortho-Design secures FDA clearance for ZSmile. Explore what pneumatic aligners mean for orthodontic innovation and adoption.
Medical Devices & Diagnostics
Medical Devices & Diagnostics
What Applied Medical Technology’s Explant Express FDA clearance reveals about breast implant explantation workflows
FDA clears Explant Express for ruptured breast implant removal. Explore what this means for surgical workflows, adoption risks, and explantation standardisation.
Medical Devices & Diagnostics
What KORU Medical’s RYSTIGGO delivery clearance means for subcutaneous infusion models
KORU Medical’s FreedomEDGE gets FDA clearance for RYSTIGGO delivery in clinics. Find out how this expands access to gMG therapy and reshapes infusion workflows.
Medical Devices & Diagnostics
What makes Break Wave different? SonoMotion’s FDA clearance puts ultrasound lithotripsy in the spotlight
SonoMotion’s Break Wave lithotripsy device wins FDA clearance for non-invasive kidney stone treatment. Find out what this changes for urology practices.
Medical Devices & Diagnostics
Will cartridge-based CBC systems replace central labs? Henry Schein bets on it with CitoCBC
Find out how Henry Schein’s exclusive U.S. deal for CytoChip’s CLIA-waived CitoCBC could reshape point-of-care blood diagnostics.
Medical Devices & Diagnostics
FDA clears BEAR Implant label for lower osteoarthritis risk: What this changes in ACL surgery
FDA clears PTOA risk reduction claim for Miach Orthopaedics’ BEAR Implant. Find out what this means for ACL treatment, patients, and future adoption.
Medical Devices & Diagnostics
FDA clears 3DICOM MD Cloud: What this means for Singular Health’s U.S. expansion and diagnostic imaging disruption
The U.S. Food and Drug Administration has granted 510(k) clearance to Singular Health Limited’s 3DICOM MD Cloud platform, expanding the Australian company’s regulated product portfolio in the United States. This marks the second FDA approval for the company’s medical imaging software line, following the clearance of its desktop-based 3DICOM MD Viewer in October 2022. The
Medical Devices & Diagnostics
Welldoc seeks FDA nod for AI-based glucose prediction in non-insulin type 2 diabetes
Welldoc’s CGM-based glucose prediction tool for non-insulin users is now under FDA review. Find out what it could change in diabetes care.
Medical Devices & Diagnostics
Can subcutaneous infusion disrupt oncology workflows? Inside KORU Medical’s 510(k) strategy for FreedomEDGE
KORU Medical’s 510(k) filing for FreedomEDGE with PHESGO could reshape subcutaneous cancer therapy. Find out what this means for oncology care delivery.