Regulatory

Covidien has gained CE Mark approval for its EverFlex™ Self-expanding Peripheral Stent with Entrust™ Delivery System which it says is designed to allow physicians to consistently place stents in the desired location with accuracy and ease.

Diagnostic device company Welch Allyn, has received FDA 510(k) clearance to market its iExaminer™ iPhone compatible image capture system that allows healthcare providers to capture, store, send and retrieve images from the Welch Allyn PanOptic™ Ophthalmoscope using the iPhone® 4 or 4S.

Infrascan gained FDA approval in late 2011 for its noninvasive haematome detection device. Now, as is the way of things, version 2 has gained the agency’s nod, featuring a more “ruggedized” build for military and other field operations.

Zimmer has received FDA 510(k) clearance to market iASSIST™ Knee, the Personalized Guidance System™ for knee replacement procedures. Zimmer says its device provides simple, intuitive and accurate intraoperative feedback and alignment validation to surgeons during joint replacement procedures, eliminating the need for bulky capital equipment.

U.S. medtech company Integra has received European CE Mark Certification for its Integra® Flowable Wound Matrix, which it describes as an advanced device for filling deep soft tissue or tunneling wounds, including diabetic foot and leg ulcers.

Occlusion of the Left Atrial Appendage has become a recognised preventative measure in the AF patient, this anatomical feature being the source of the majority of clots. Now occlusion has been made easier with the CE marking and introduction of a next generation device from St.Jude Medical, Inc.

Some patients in some situations still benefit from metal-on-metal hips. The FDA has now issued a guidance document, laying out its considered view on the use of these devices, including ongoing assessment of patients already implanted with them.

St. Jude Medical, Inc. has gained U.S. FDA approval for its next-generation Merlin.net™ Patient Care Network (PCN), a secure, Internet-based remote care system for patients with implanted medical devices.

Gore has received FDA approval to extend its AAA range to include a new large diameter 35 mm trunk-ipsilateral leg and 36 mm aortic extender components, as well as the lower profile 31 mm diameter trunk-ipsilateral leg and 32 mm aortic extender components of the GORE® EXCLUDER® AAA Endoprosthesis.

Drug resistant depression is a problem with a new solution in the U.S. now that the FDA has given Brainsway’s non invasive magnetic stimulation device the nod.

Olive Medical Corporation of Salt Lake City, has announced FDA 510K clearance and the worldwide sales launch for the OVS1 All-in-one HD Visualisation system.

The UK’s National Institute for Health and Clinical Excellence (NICE) has published new guidance supporting the use of the Exogen device to heal long bone fractures with non-union at 9 months, but uncertainties in the evidence mean the jury is still out on 3 month old non-unions.

Mitral valve repair specialist company NeoChord, has received CE-marking for its technology that allows the implantation of artificial chordae tendinae, a proven technique for the repair of mitral valve prolapse, via a transapical, off-pump procedure.

Early stage orthopedic device company, Soft Tissue Regeneration, has developed a breakthrough tissue engineering platform used to regenerate ligaments and tendons. The company has announced that it has received FDA clearance to market its STR GRAFT, a biodegradable scaffold used for soft tissue augmentation and rotator cuff repair.

Abbott’s XIENCE Xpedition™ Everolimus Eluting Coronary Stent System has received U.S. FDA approval and is to be launched immediately in the United States.

Medical Modeling Inc., has received FDA 510(k) clearance for its innovative VSP® System product line. Initial applications of the technology include products such as VSP® Orthognathics – Applying virtual surgical planning and CAD/CAM surgical splints to the area of orthognathic surgery, and VSP® Reconstruction – Applying virtual surgical planning to the reconstruction of the mandible or maxilla using vascularized grafts from other areas of the body.