Foldax Signs Indian Manufacturer to Help Expedite Mitral Valve Commercialization in the Country

Heart Valve Pioneer Foldax® Inc., will see its innovative TRIA™ polymer mitral surgical heart valves being manufactured in India. A newly … continue reading “Foldax Signs Indian Manufacturer to Help Expedite Mitral Valve Commercialization in the Country”

FDA approves Recor Medical’s Paradise™ Ultrasound Renal Denervation for Hypertension

Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) have announced the U.S. … continue reading “FDA approves Recor Medical’s Paradise™ Ultrasound Renal Denervation for Hypertension”

First Limus Drug-eluting Balloon for US as SELUTION SLR™ Gets FDA IDE Approval

MedAlliance’s SELUTION SLR™ drug-eluting balloon (DEB) has received FDA Investigational Device Exemption (IDE) approval, making it the first limus DEB … continue reading “First Limus Drug-eluting Balloon for US as SELUTION SLR™ Gets FDA IDE Approval”

Japanese PMDA Approval for BioFreedom™ Ultra and US FDA Approval for BioFreedom™

Biosensors International Group, Ltd. has announced the Japanese PMDA Approval for BioFreedom™ Ultra and US FDA Approval for BioFreedom™. Background … continue reading “Japanese PMDA Approval for BioFreedom™ Ultra and US FDA Approval for BioFreedom™”

Wision A.I. Expands U.S. Offerings to Combat Colorectal Cancer With Multiple Screening Tools

Wision A.I. Ltd. has announced the expansion of its product portfolio with recent U.S. FDA 510(k) Clearance for EndoScreener, its … continue reading “Wision A.I. Expands U.S. Offerings to Combat Colorectal Cancer With Multiple Screening Tools”

U.S. FDA Approves Pipeline™ Flex Embolization Device with Shield Technology™

Medtronic plc has received U.S. FDA approval for Pipeline™ Flex Embolization Device with Shield Technology™. Background An estimated 500,000 people throughout the … continue reading “U.S. FDA Approves Pipeline™ Flex Embolization Device with Shield Technology™”