FDA to Get Tough on All-Metal Hip Implants

Posted on : 28 January 2013
A proposed rule change would require manufacturers to prove safety and efficacy. Read more

FDA Considers a Downgrade of the Regulatory Status for Scleral Plugs

Posted on : 28 January 2013
The FDA may exempt certain scleral plugs from the 510(k) regulatory process after deciding the the dvices do not need the additional safety and effectiveness controls where they are made from stainless steel.  Read more

Guidance System Reduces Complexity and Cost of Knee Replacement Procedures

Posted on : 24 January 2013
The FDA has given the go-ahead for Zimmer's iASSIST Knee system. Read more

Computerised System to Control Anaesthetic Delivery

Posted on : 23 January 2013
A closed loop anaesthesia delivery system has been developed under a project funded by the Department of Information Technology, New Delhi.  Read more

CE Mark for Two St. Jude Devices

Posted on : 23 January 2013
St. Jude Medical has received CE Mark approval for the Amplatzer Amulet Left Atrial Appendage Occluder and the ViewFlex Xtra Intracardiac Echocardiography Catheter.  Read more

FDA to Host a Public Workshop on Standardised Medical Device Labelling

Posted on : 22 January 2013
The two-day public session takes place in April.  Read more

European Study Compares Patient Outcomes of Two Leading TAVI Devices

Posted on : 22 January 2013
The results showed no apparent difference in patient outcomes except the Medtronic CoreValve was associated with more permanent pacemakers than the Edwards Sapien XT. Read more

Clinical Trial in India & Europe for Mitral Regurgitation Device

Posted on : 16 January 2013
The trial will assess the safety and efficacy of the adjustable tension band device. Read more

The Advance of Robotic Surgery

Posted on : 16 January 2013
A 71 year old patient's experience of robotic surgery is used to demonstrate its application.  Read more

FDA Approves LED Light Therapy Device

Posted on : 14 January 2013
It can be used for acne treatment, muscle and joint pain, muscle and joint stiffness, muscle spasm, arthritis and compromised local blood circulation.  Read more

FDA Approves Spinal Implant Devices

Posted on : 14 January 2013
The less-invasive medical devices for treating a range of spinal diseases.  Read more

Clinical Trial Commences for Drug Eluting Stent

Posted on : 14 January 2013
A drug-eluting bioresorbable stent will evaluated for use in patients with coronary artery disease.  Read more

US Research Demonstrates that Defibrillators Live Up to Clinical Trials

Posted on : 09 January 2013
Patients have similar survival benefits to those who receive the same devices in clinical trials.  Read more

FDA Approves Graft for Rotator Cuff Repair

Posted on : 09 January 2013
The biodegradable graft can be used for soft tissue augmentation and rotator cuff repair. Read more

World Health Organisation Calls for Innovative Health Technologies Ideas

Posted on : 07 January 2013
Selected submissions will be published in the WHO Compendium of innovative health technologies 2013. Read more

CE Mark for New Mitral Valve Repair Technology

Posted on : 07 January 2013
CE mark achieved for mitral valve repair technology that allows the implantation of artificial chordae tendinae via a transapical off-pump procedure.  Read more

30,000 of Donations Place 187 Oximeters in Low Resource Hospitals

Posted on : 07 January 2013
Generous BMJ readers donated 30,000 the BMJ's Lifebox Foundation Christmas Appeal. Read more

US Cardiologist Calls for More Data on FDA Approved Defibrillator

Posted on : 03 January 2013
More data may be needed on the safety and effectiveness of the wire-free implantable defibrillator. Read more

New Cutter/Stapler Device Available in Europe

Posted on : 03 January 2013
The dual use device, intended for use in laparoscopic and thoracoscopic procedures, allows surgeons to deliver multiple staples without needing to reload cartridges. Read more

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