meddevice

MedShape’s funky new tibial fixation device for use in ACL surgery looks promising, and having been CE marked for getting on for a year we might have expected to know how to buy it by now.

FDA warns DePuy about the use of custom device exemption to allegedly supply devices that don’t fit FDA’s definition of custom. DePuy then ceases manufacturing all custom devices.

After studying data relating to 3404 hips enrolled in 18 comparative studies and over 830 000 operations in national registries, researchers showed only limited evidence of comparative effectiveness of various hip implant bearing combinations.

“Our patients need protecting from these monsters” implies Radio 4 interview on the subject of medical devices regulation.

The bodies representing Europe’s Diagnostic and Medical Devices industries are to form a gang in order to “gain a louder voice in areas of common interest to their respective stakeholders”.

Biomet, Inc., has announced FDA clearance of two new products; the E1® humeral bearing for use with the Comprehensive® Reverse Shoulder System, and the Comprehensive® Segmental Revision System.

A worldwide report on the products, technologies and markets in wound closure and anti-adhesion.

Which Medical Device (whichmedicaldevice.com) has announced the winners of its “Device of the Year” awards, based on assessment of reader feedback by the expert judging panel.

Synvasive’s eLIBRA® knee balancing system will shortly be available from Zimmer following the recently announced acquisition.

Many large American companies consider the Far East to represent the best chance for growth, while paradoxically Chinese manufacturers are looking at USA as an opportunity to increase their own revenues.

In common with other medical device manufacturers, BIOTRONIK clearly sees the growth opportunity in the Far East, announcing the opening of a new regional headquarters in Singapore.

Please, no more talk of who’s to blame and who’s carrying the can. This week’s VFTM is a breast-free zone… almost.

Surgeons at the Karolinska Institute in Sweden have implanted a second patient with a synthetic trachea formed from CT scans of the patient’s own anatomy and seeded with his own stem cells.

In this editorial we ask whether it’s joined up thinking to claim that the PIP situation, just because it’s a private sector issue, means all private healthcare will be riddled with problems and providers not willing to cooperate on their solution?

Results from the St Jude sponsored ASSERT study has found that pacemaker patients who have no history of atrial tachycardia (AT) or AF, but do have device-detected arrhythmias, are approximately 2.5 times more likely to have a stroke than patients who do not have device-detected arrhythmias.

UK based test equipment company Rigel Ltd has announced that Carl Zeiss Ltd, a global market leader in precision optics and engineering technology, has specified the Rigel Medical 62353 medical safety analyser to comply with IEC 62353, the standard for in-service and after repair testing of medical electronic devices.