Category:
FDA
Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.
ManaMed Reports Revolutionary Wearable Ultrasound Device Gains FDA Approval
The ManaSport device, is a new ultrasound therapy device that provides pain relief and treatment for soft-tissue injuries and is popular among athletes & sports professionals reports ManaMed.
Lumendi Files for 510(k) Clearance for 2 New Products
DiLumen EZ¹, a single-use and DiLumen C¹ by Lumendi.
Nellcor OxySoft Neonatal-adult SpO2 Sensor by Medtronic Receives FDA Clearance
Nellcor OxySoft Neonatal-adult SpO2 Sensor will help clinicians respond quickly with well-informed decisions for their critical care patients.
Minnetronix Medical Sharpens Image Quality for the First FDA-Cleared Wireless Surgical Camera
ArthoFree is the first and only such wireless surgical camera system to receive FDA 510(k) market clearance.
Biobeat Remote Patient Monitoring Device and Platform: FDA Cleared for Additional Vital Signs
Biobeat notes their wireless wrist and chest monitoring devices, the first-ever to receive FDA clearance for cuffless blood pressure monitoring from PPG only, can support health teams by transmitting real-time patient data.
Medtronic Receives FDA Approval for Latest Generation Drug-eluting Coronary Stent System
The Onyx Frontier DES is used for the treatment of patients with coronary artery disease (CAD), which is caused by plaque buildup on the inside of the coronary arteries.
Accelus Receives U.S. FDA 510(k) Clearance for its FlareHawk TiHawk11 Interbody Fusion System
TiHawk11 is the latest addition to the company's flagship FlareHawk® portfolio of spinal fusion cages, which are now available in a larger footprint with titanium at the bony interface. Accelus adds TiHawk11 features an 11mm-wide insertion profile and expands to 17mm in width and 14mm in height, providing 70% more footprint than a 10mm-wide interbody device of identical length.
Access Vascular Receives FDA Clearance for HydroPICC® Biomaterial-Based Dual-Lumen Catheter
The single- and dual-lumen biomaterial catheters allow hospitals to reduce thrombosis and vascular access complications for majority of PICC applications advises Access Vascular.
Median Technologies Is Moving Forward With the FDA Interactions for Its iBiopsy® Lung Cancer Screening CADe/CADx Software as Medical Device
Median Technologies will proceed through a 510(k) submission to obtain an FDA device clearance and market authorization, targeted for the end 2023.
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