What Anumana’s FDA-cleared pulmonary hypertension algorithm means for cardiovascular AI
Anumana won FDA clearance for an ECG-AI pulmonary hypertension tool. Read what it changes for diagnosis, workflow adoption, and cardiovascular AI strategy.
What FDA clearance means for Median Technologies eyonis LCS in a crowded AI radiology market
Median Technologies advances eyonis LCS after FDA clearance. Discover what this means for AI lung cancer screening and European expansion.
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.
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.
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.
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.
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.
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.
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 […]
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.