RingConn Receives FDA 510(k) Clearance for Non-Invasive Blood Oxygen (SpO2) Measurement
Shenzhen, China, Oct. 10, 2026 /PRNewswire/ -- Shenzhen Ninenovo Technology Limited, the parent company of RingConn, announced that its Smart Ring has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for non-invasive blood...
Wellysis Secures FDA 510(k) Clearance for AI-Powered ECG Analysis Software, S-Patch CardioAI
Adds FDA-cleared AI analysis to Wellysis' S-Patch ECG monitoring solution, expanding its capabilities beyond ECG acquisition Enables FDA-cleared AI analysis of S-Patch ECG data to be integrated into third-party ECG platforms and existing clinical...
Bracco Marks Major Global Milestone with U.S. FDA 510(k) Clearance and Health Canada Authorization for VueJect®, the First Dedicated Ultrasound Contrast Delivery System to Support Cardiology Imaging
VueJect ® strengthens Bracco's integrated CEUS ecosystem by enabling more standardized, efficient contrast administration in cardiology imaging MILAN, Aug. 11, 2026 /PRNewswire/ -- Bracco Imaging today announced that VueJect®, its first dedicated...
NIPRO CORPORATION Receives FDA 510(k) Clearance for ELISIO™-HX, Introducing HDs to the United States
New medium-cutoff Dialyzer with a Super High-flux membrane brings NIPRO's approach to expanded hemodialysis to United States healthcare providers. OSAKA, Japan, July 30, 2026 /PRNewswire/ -- NIPRO CORPORATION has been granted 510(k) clearance for...
Australian medtech Navi raises $A6.8 million to commercialise breakthrough paediatric technology in the US
MELBOURNE, Australia and BOSTON, July 29, 2026 /PRNewswire/ -- Melbourne- and Boston-based medical device company Navi Medical Technologies has closed a $A6.8 million capital raise to commercialise its breakthrough paediatric vascular access...
HoneyNaps Receives U.S. FDA 510(k) Clearance for SOMNUM V3.0 for AI-Based Sleep-Disordered Breathing Analysis
- FDA 510(k) Clearance (K253390) Validates AI-Based Classification of OSA, CSA, and MSA - Subtype-Specific Respiratory Event Analysis Improves Diagnostic Precision and Supports Next-Generation Digital Biomarker Development - Advanced AI Analysis...
STARMED Receives FDA 510(k) Clearance for a Benign Thyroid Nodule Ablation Indication
SEOUL, South Korea, July 1, 2026 /PRNewswire/ -- STARMED, a medical device company specialising in minimally invasive treatment technologies, has announced that it has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for a...
FDA Clears PanopticAI's Contactless Respiratory Rate Measurement
Following the startup's first FDA 510 (k) clearance for its contactless pulse rate monitoring, PanopticAI has now secured a second one for respiratory rate measurement. This milestone cements its position as the world leader in camera-based...
SKIA HEAD: AR Surgical Guidance Receives FDA 510(k) Clearance, Eyes U.S. Expansion with Structure Partnership
SEOUL, South Korea, May 29, 2026 /PRNewswire/ -- South Korea-based medtech innovator SKIA has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its augmented reality (AR) surgical guidance system, SKIA HEAD....
3Shape Receives FDA 510(k) Clearance for 3Shape Dx Software
COPENHAGEN, Denmark, April 28, 2026 /PRNewswire/ -- 3Shape today announced that the U.S. Food and Drug Administration (FDA) has granted FDA clearance for its Dx Software following a review completed on April 10. 2026. The 510(k) Premarket...