SuperSonic Imagine, a medical ultrasound company, announced its Aixplorer MultiWave ultrasound system has obtained the US Food and Drug Administration (FDA) approval for the quantification capabilities of its real-time ShearWave ...
Tags: SuperSonic Imagine, Medicine
Bausch + Lomb, a subsidiary of Valeant Pharmaceuticals International, has obtained marketing clearance from the US Food and Drug Administration (FDA) for its newest frequent replacement silicone hydrogel contact lenses made with ...
Tags: Contact Lens, Medicine
Actuated Medical, a US-based medical device company, has obtained the additional US Food and Drug Administration (FDA) approval for its TubeClear system. The company has added several new clearing stem models for the TubeClear system and ...
Tags: Actuated Medical, medical device
US-based in vitro diagnostic company Venaxis announced that the Data and Safety Monitoring Board (DSMD) has recommended the continuation of pivotal clinical trial of the APPY1 test, a multiple biomarker-based assay for identifying patients ...
Tags: Appy1 Test, Clinical Trial
IntelligentMDx (IMDx) has received the US Food and Drug Administration (FDA) approval for its second automated molecular diagnostic test for use on Abbott's fully automated m2000 platform. The automated molecular diagnostic test detects ...
StelKast, a manufacturer and distributor of orthopedic implants for knee replacement and hip replacement, has received 510(k) clearance from the US Food and Drug Administration (FDA) to market EXp for the Proven Gen-Flex total knee system. ...
Tags: Stelkast, Total Knee System
SpineGuard has received 510(k) clearance from the US Food and Drug Administration (FDA) for three new products, designed to enhance pedicle screw penetration of small and/or difficult-to-access pedicles. The two miniaturized versions of ...
Tags: Pediguard Products, SpineGuard
Boston Scientific has received the US Food and Drug Administration (FDA) approval for its IntellaTip MiFi XP catheter and 510(k) clearance for its Zurpaz 8.5F steerable sheath. The IntellaTip MiFi XP is a high resolution catheter that ...
Tags: Cardiac Devices, Drug
Reverse Medical has received the 510(k) clearance from the US Food and Drug Administration (FDA) for its MVP Micro Vascular Plug system, which is designed for peripheral artery embolization. MVP Micro Vascular Plug system is used to ...
Tags: Reverse Medical, Medicine
Denmark-based health care company Novo Nordisk has won US FDA 510(k) clearance for the insulin injection device, NovoPen Echo, combining half-unit dosing with a memory function to help patients manage their diabetes. Available to patients ...
Tags: Insulin Injection, Medicine
Clearance, an AngioDynamics company, has received the US Food and Drug Administration (FDA) 510(k) clearance for its BioFlo Port with Endexo technology, Clearance to the accumulation of platelets and thrombus. The BioFlo Port is a ...
CoAlign Innovations, a US-based medical device company, has received the US Food and Drug Administration (FDA) approval for its AccuLIF XL lateral expandable interbody fusion devices. The new AccuLIF interbody system utilizes low-profile ...
St. Jude Medical, a US-based medical technology company, has received the U.S. Food and Drug Administration (FDA) approval for its new MediGuide Enabled Ablation Catheters designed to treat specific irregular heartbeats. Utah Valley ...
RTI Surgical, a manufacturer of orthopaedic and other biologic implants, has launched Tritium Sternal Cable Plating (SCP) system for closing median sternotomies following open heart procedures. The device incorporates the advantages of ...
Tags: RTI Surgical, Cable Plating System
Verizon, a US- based broadband and telecommunications company, has received the US Food and Drug Administration (FDA) 510(k) clearance for a cloud-based, remote patient-monitoring medical device called Converged Health Management. ...
Tags: Verizon, Patient-Monitoring Device