Products

Boston Scientific Corporation tells us it has obtained CE mark for the ACURATE Prime™ Aortic Valve System. Indeed it is … continue reading “ACURATE Prime™, Boston Scientific’s New Aortic Valve System Gains CE Mark”

Wearable technology is the focus of ResearchAndMarkets’ new report which points to rising demand for home healthcare and remote monitoring. … continue reading “Wearable Technology in Medical Devices: New Global Markets Report”

A pioneering non-invasive neurostimulation technology for chronic insomnia will be showcased on the ABHI UK Pavilion at China’s CMEF 2024, … continue reading “Insomnia Neurostimulation Tech on Show in China”

The Emboliner “Protect the Head to Head” investigational device exemption (IDE) clinical trial has seen its one hundredth patient enrolled. … continue reading “Emboliner ® IDE Study 100 Patient Milestone”

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”

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”

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”

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?”

The global drug eluting stent (DES) market size is expected to reach USD 13.65 billion by 2030, advancing at a … continue reading “Drug Eluting Stent Market Growth Predicted”

Scoliosis management has gained a new string to its bow in the United States. The FDA has cleared NSite Medical’s … continue reading “Scoliosis Management Boost as FDA Clears AI-Solution”

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”

Medtronic plc says the US FDA has approved the Symplicity Spyral ™ renal denervation (RDN) system as an adjunct to … continue reading “Spyral ™ Gains FDA Approval”

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”

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”

Medtronic plc, has received U.S. FDA 510(k) clearance and Breakthrough Device designation for its novel LigaPASS™ 2.0 Ligament Augmentation System. … continue reading “FDA Clears First Spine Device for Ligament Augmentation”

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”