VARIPULSE™ Pulse Field Ablation (PFA) Platform Gains CE Mark

Biosense Webster, Inc., has announced European CE mark approval of the VARIPULSE™ Platform. The approval covers the treatment of symptomatic drug refractory … continue reading “VARIPULSE™ Pulse Field Ablation (PFA) Platform Gains CE Mark”

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”

ABHI Warns that Unworkable HealthTech Procurement Means 1 in 3 Companies have Chosen to Not Bid on Tenders

A press release from the UK’s Association of British HealthTech Industries (ABHI) signals a warning for regulators and NHS procurement. … continue reading “ABHI Warns that Unworkable HealthTech Procurement Means 1 in 3 Companies have Chosen to Not Bid on Tenders”

Medtech Regulatory and Commercial Landscape Considerations: UK, US, or EU first?

Feature article by Timothy Bubb, Medtech regulatory specialist and TechnicalDirector at IMed consultancy. Technology is taking an increasingly central place … continue reading “Medtech Regulatory and Commercial Landscape Considerations: UK, US, or EU first?”

Orthopedic Device Market to Grow by USD 12.11 Bn Between 2022 and 2027 Says New Report

Global technology research and advisory company Technavio says the market size for orthopedic devices size is set to grow by USD 12.11 billion from … continue reading “Orthopedic Device Market to Grow by USD 12.11 Bn Between 2022 and 2027 Says New Report”

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”

Neuromodulation specialist CVRx Launches new Barostim NEO2™ Implantable Pulse Generator

CVRx, Inc., developer of the world’s first FDA-approved neuromodulation device to treat the symptoms of heart failure, has launched its … continue reading “Neuromodulation specialist CVRx Launches new Barostim NEO2™ Implantable Pulse Generator”

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™”