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BD Completes Acquisition of Critical Care from Edwards Lifesciences

BD Completes Acquisition of Critical Care from Edwards Lifesciences

BD (Becton, Dickinson and Company) has completed the acquisition of Edwards Lifesciences' Critical Care product group. Full release here. A frequent visitor to our pages,…

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Cardio

ACURATE Prime™, Boston Scientific's New Aortic Valve System Gains CE Mark

ACURATE Prime™, Boston Scientific's New Aortic Valve System Gains CE Mark

Boston Scientific Corporation tells us it has obtained CE mark for the ACURATE Prime™ Aortic Valve System. Indeed it is…

Trio of Acquisitions to Reinforce Edwards Lifesciences Heart Portfolio

Trio of Acquisitions to Reinforce Edwards Lifesciences Heart Portfolio

Last month (July 2024) Edwards Lifesciences announced it is to acquire JenaValve Technology, a pioneer in the transcatheter treatment of aortic…

Jupiter Endovascular Funding Means Green Light for Pulmonary Embolism Pivotal Trial

Jupiter Endovascular Funding Means Green Light for Pulmonary Embolism Pivotal Trial

New funding will be used to support Jupiter Endovascular in its upcoming pivotal trial for Pulmonary Embolism. It will also aid development of additional clinical…

Approval / Clearance

Insomnia Neurostimulation Tech on Show in China

Insomnia Neurostimulation Tech on Show in China

A pioneering non-invasive neurostimulation technology for chronic insomnia will be showcased on the ABHI UK Pavilion at China’s CMEF 2024, which takes place in Shanghai,…

Emboliner ® IDE Study 100 Patient Milestone

Emboliner ® IDE Study 100 Patient Milestone

The Emboliner “Protect the Head to Head” investigational device exemption (IDE) clinical trial has seen its one hundredth patient enrolled.…

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

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 recurrent paroxysmal atrial fibrillation (AF).…

Clinical Studies / Trials

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

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 announced agreement with Dolphin Life…

Medovate and JEB Technologies Join Forces

Medovate and JEB Technologies Join Forces

East of England – based Medovate Ltd. and JEB Technologies Ltd., have become part of the same group structure. In effect their new collaboration will…

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

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. Indeed it suggests that existing…

Products

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

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 in healthcare. Drivers include advances…

Drug Eluting Stent Market Growth Predicted

The global drug eluting stent (DES) market size is expected to reach USD 13.65 billion by 2030, advancing at a CAGR of 8.4%. So says a new report from ResearchAndMarkets.com. The new report is entitled “Drug…

Alzheimer’s Cognito Sensory Stimulation Study Promise

Alzheimer’s Cognito Sensory Stimulation Study Promise

Cognito Therapeutics has announced publication of MRI imaging data from its Phase 2 OVERTURE study in the Journal of Alzheimer’s Disease (AD). The promising study demonstrates…

Regulatory

Scoliosis Management Boost as FDA Clears AI-Solution

Scoliosis Management Boost as FDA Clears AI-Solution

Scoliosis management has gained a new string to its bow in the United States. The FDA has cleared NSite Medical’s AI-based scoliosis scanning application. Scoliosis…

Hemodialysis Access Promise from Polymer Implant

Netherlands and US-based medtech company Xeltis tells us about its first-in-human (FIH) vascular conduit trial for hemodialysis access. Vascular surgeon Prof. Dr. Frans Moll presented the data at the 50thAnnual VEITH symposium in New York.…

First O.U.S. Patients Get TRIA Biopolymer Surgical Aortic Valve™

First O.U.S. Patients Get TRIA Biopolymer Surgical Aortic Valve™

Foldax®, Inc. says the first patients have been enrolled in the Drugs Controller General of India (DCGI)-approved clinical trial of the TRIA™ biopolymer surgical aortic…

Companies

First-Ever Pivotal Trial of Synthetic Restorative Pulmonary Heart Valve

First-Ever Pivotal Trial of Synthetic Restorative Pulmonary Heart Valve

Based in Eindhoven, Netherlands, Xeltis is a clinical-stage developer of advanced polymer-based restorative cardiovascular devices. The company has now announced the start of the first-ever…

UK Innovations Launched at Arab Health 2020

UK Innovations Launched at Arab Health 2020

The Association of British HealthTech Industries (ABHI) has revealed some of what it describes as ground-breaking digital health technologies, services and products being launched at…

Non-Invasive Headache Therapy System Selected for NHS England Innovation and Technology Payment Program

electroCore, Inc., a commercial-stage bioelectronic medicine company, tells us that its gammaCore non-invasive vagus nerve stimulator (nVNS), has been selected for the Innovation and Technology Payment (ITP) Program by NHS England for use in the…