Products

The AliveCor™ Heart Monitor is a single-channel ECG recorder that works with your iPhone or android device to record,store and transfer heart data for people requiring monitoring. Previously cleared for issue by prescription only, the device is now available for Over the Counter pre-order purchase, with shipments beginning in March.

Ellipse Technologies has received U.S. FDA marketing clearance of the Precice® 2 Intramedullary Limb Lengthening System, based on the principle of non-invasive adjustment.

Regenerative medicine company Acell, Inc., has announced the launch of its new MatriStem® Multilayer Wound Matrix device for deep, hard-to-heal, full-thickness wounds.

Edwards Lifesciences Corporation has received CE Mark approval for the use of its SAPIEN XT transcatheter heart valve for valve-in-valve procedures, where failing bioprosthetic valves require intervention.

With total joint implants, one tiny mistake can have significant consequences. In this case no patient injury has been reported, but labelling within the Mathys balanSys Knee system incorrectly matches tibial and femoral components, with the risk of subsequent instability and pain. The company has issued a field safety notice.

The U.S. FDA has issued 510(k) Clearance for Nidek’s revolutionary new CEM-530 Specular Microscope that acquires images of the corneal endothelium and provides analysis very quickly and easily.

Ideas like this have been mooted for many years: An ACL femoral fixation implant that doesn’t need to be screwed in, yet retains firm graft/tunnel apposition. MedShape makes the most of its proprietary memory shape PEEK Altera material to form what it hopes is the perfect solution.

Zimmer Spine’s flexible, cancellous bone allografts are used in spine surgery, either alone or as a bone graft extender to stimulate natural bone formation processes. New configurations make life easier for surgeons by reducing the need for shaping during procedures.

Leeds, UK-based Brandon Medical is launching a new range of LED examination lights that it claims are the most advanced of their type available anywhere in the World.

Medtronic has taken the opportunity presented by this weeks Thoracic Society meeting to announce that it has gained U.S. FDA approval for its Valiant Captivia Thoracic Stent Graft System to be used in the treatment of type B aortic dissections.

AtheroMed has announced the FDA’s clearance to market the Phoenix Atherectomy System, which allows physicians to treat PAD with a low profile atherectomy catheter that continuously removes diseased material as it is debulked and does not require specialized capital equipment.

eNeura Inc., a privately held medical technology company, has announced the filing of a 510(k) with the U.S. FDA for the SpringTMS® transcranial magnetic stimulation (TMS) device, a progression from its already approved CerenaTMS solution for migraine treatment.

The Kiva® VCF Treatment System by Benvenue Medical, Inc. has received U.S. FDA 510(k) clearance for the reduction and treatment of spinal fractures. The company says its implant based system is the first departure from balloon kyphoplasty for a decade.

ReCor Medical’s Paradise Renal Denervation System uses ultrasound energy to do the job, compared with the RF used by its major competitors. In the wake of Symplicity HTN-3’s poor results, ReCor is keen to put some fresh air between its approach and that of the opposition, pointing to favourable outcomes in patients who had already been treated with RF energy.

Edwards Lifesciences Corporation has received CE Mark approval for the SAPIEN 3 valve. European launch of what Edwards is calling its most advanced transcatheter aortic valve is imminent.

Medtronic, Inc. has announced the U.S. FDA approval of its Medtronic SureScan® pacing systems that are compatible with use of MRI scanning on any region of the body.