Smith & Nephew has announced that the UK’s National Institute for Health and Clinical Excellence (NICE) has issued draft guidance supporting the case for utilising the Exogen Ultrasound Bone Healing System. It’s now putting its draft findings out for consultation.
Technology
CE Mark For Cerbomed’s Transcutaneous Vagus Nerve Stimulation Pain Relief Indication
Germans medical device company Cerbomed GmbH has received CE mark clearance for the application of transcutaneous Vagus Nerve Stimulation (t-VNS) in pain relief therapy.
NICE Publishes Positive Final Guidance On Device For Use During Electrosurgery
The National Institute for Health and Clinical Excellence has published final guidance on a new medical technology device designed to be used during surgery. The guidance advises that the use of the Mega Soft Patient Return Electrode could help reduce the risk of localised burns during monopolar electrosurgery
Covalon Announces FDA Clearance For SurgiClear™ Antimicrobial Silicone Wound Dressing
Covalon Announces FDA Clearance for SurgiClear™ Antimicrobial Silicone Wound Dressing (via PR Newswire) MISSISSAUGA, ON, Aug. 21, 2012 /PRNewswire/ – … continue reading “Covalon Announces FDA Clearance For SurgiClear™ Antimicrobial Silicone Wound Dressing”
Medtronic’s Newly CE Marked Cardiac Resynchronisation Therapy Devices Preserve Normal Heart Rhythm
Medtronic has announced CE mark approval for two new CRT devices which automatically adapt to patients’ electrical rhythms, improving response to life-saving therapy.
Attrius® Cardiac PET System Gains CE Mark
Based out of Shenyang, China, Neusoft Positron Medical Systems, a joint venture between Neusoft Medical Systems Co., Ltd., and Positron Corporation has received ISO certification (9001:2008 & 13485:2003) and CE Mark approval for the Attrius® PET Systems.
New Remote Monitoring System Cuts Cardio Patient Wait From 84 Minutes To Under 15 Minutes Says Medtronic
Medtronic’s CareLink Express monitor, compatible with almost all Medtronic ICDs, CRT devices, ICMs and pacemakers, “interrogates” implanted Medtronic cardiac devices. In so doing it shortcuts repeated tests and the need for on site specialists, in so doing reducing delays and increasing efficiency…. at least for Medtronic implantees.
University Researchers’ Polymers Prevent Bacterial Attachment To Devices
Scientists at UK’s University of Nottingham may have identified a new class of polymers that could lead to a significant reduction in hospital infections and medical device failures by preventing bacterial attachment to their surfaces.
Good News For Artificial Heart Company SynCardia As It Posts Record Figures
SynCardia Systems, Inc., manufacturer of the world’s first and only FDA, Health Canada and CE approved Total Artificial Heart, has announced revenue for the quarter ended June 30, 2012, marking the company’s best quarter to date and its fifth consecutive profitable quarter.
Sunshine Getting Investors’ Hearts Racing
Sunshine Heart tells us it’s come up with a device upgrade which will make its CPulse heart assist device run quieter and less bulky. The company awaits the FDA’s formal confirmation that it’s good to go, but the conditional approval has been announced. And the share price has gone up.
Covidien Cements Committment To China As New R&D Facility Is Opened
With the opening of its new $45M facility Covidien’s investment in China is significant and a sure sign that the healthcare giant sees the Far East as the medtech powerhouse in years to come.
First-In-Human Use For ART’s Bioresorbable Stent
ART reckons its bioresorbable coronary stent will disappear in a predictable timeframe because of its “programmed transitory presence”. Despite the sci-fi language it sounds like a smart product if it works… time will tell as the company undertakes its first in man clinical study.
CE Mark For Boston Sci’s MRI Compatible Pacemakers
Boston Scientific Corporation has received CE Mark approval for use of its MRI compatible INGENIO™ and ADVANTIO™ pacemakers
MiMedx Group Turns A profit From Human Amniotic Membrane
Georgia’s Mimedx Group is a developer of biomaterial solutions for surgical repair of soft tissues using human amniotic membrane. Pretty specialised field and never likely to be sponsoring the Olympics, but nonetheless the company’s recently stated Q2 financials suggest it’s in good shape, having grown consistently and turned red numbers black in the past twelve months.
Read Our Weekly View From The Med Before You Watch The Opening Ceremony
Is there enough newsworthy stuff happening in medtech to justify a weekly review? Oh yes.
Milestone Alert! First FDA Cleared Robot-Assisted PCI System
Vascular robotics company Corindus Vascular Robotics, has announced FDA 510(k) clearance has been granted for its CorPath 200 System to be used in percutaneous coronary interventions (PCI).