Headline image

New Mandible Plate “Seamlessly Integrates Surgical Planning, Intraoperative Tools and Patient Specific Devices

DePuy Synthes CMF has launched its new Patient Specific Plates for Mandible surgery, bringing a new level of accuracy to the procedure and avoiding the risk of bending-induced plate breakage.


FDA Clearance for Breathe Technologies’ NIOV System for use with Compressed Gas

Headline imageBreathe Technologies, Inc. has announced the U.S. FDA 510(k) clearance of its Non-Invasive Open Ventilation (NIOV) System, opening up the potential for it to be used with a compressed air supply for non-oxygen dependent patients.

St. Jude Financials Show Revenue and Earnings Growth and Promise More of the Same

St. Jude is sounding punchy, expecting revenue gains based on a flurry of new product approvals.

ulrich medical Says Docs Prefer Titanium Interbody Devices

ulrich medical USA, Inc., has announced the U.S. market release of its tezo® spine implants for multiple surgical approaches to lumbosacral interbody fusion.

Stryker Completes Berchtold Acquisition

Back in February 2014 we covered the news that Stryker Corporation was to acquire healthcare infrastructure business, Berchtold Holdings in a deal worth $172 million. Now that deal has gone through.

FDA Clears Disposable Feeding Tube Placement Under Direct Vision

Headline imageCovidien plc has gained U.S. FDA 510(k) Clearance for its Kangaroo™ feeding tube with IRIS Technology. This first-of-its-kind camera-equipped disposable feeding tube is designed to enhance patient safety by providing visualization for a procedure that is currently blinded.

Can ROX Medical Hypertension Solution Work Where Renal Denervation Didn’t? Study Should Tell

Headline imageROX Medical has completed enrollment in its CONTROL-HTN trial, an international multi center, prospective, randomized, controlled, blinded endpoint trial of the ROX Coupler for the treatment of arterial hypertension.

ConvaTec Claims First with Moldable Technology™ One-Piece Ostomy Pouch

ConvaTec is claiming a first with the launch of its new ostomy pouch that brings the clinically-proven skin and leak protection of Moldable Technology to ostomates who prefer the convenience of a one-piece pouch.

Delamination Risk Provokes Covidien Recall of PTFE Coated Vascular Products

Headline imageCovidien plc has notified customers of a voluntary recall to address an issue with certain lots of its Pipeline™ Embolization Device and Alligator™ Retrieval Device where the polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate and detach from the devices.

Triple Whammy of Global Device Approvals for Zip® Surgical Skin Closure

ZipLine Medical says its Zip® Non-invasive surgical skin closure device is faster than sutures, can produce superior cosmesis compared to staples and reduce the risk of surgical site infection.

FDA Green Light for Boston Scientific’s New Defibrillators and Heart Failure Devices

Headline imageBoston Scientific Corporation has received FDA approval for its latest generation of defibrillators and heart failure devices, including the DYNAGEN™ MINI and INOGEN™ MINI ICDs, as well as the DYNAGEN™ X4 and INOGEN™ X4 CRT-Ds.

FDA IDE Approval for BARREL® Intracranial Bifurcation Aneurysm Solution

Reverse Medical® Corporation has gained FDA IDE approval for clinical investigation of its BARREL® Vascular Reconstruction Device (VRD). The BARREL® Vascular Reconstruction Device is designed for use with occlusive devices in the treatment of intracranial bifurcation aneurysms.

UK’s NICE Opens Consultation on ‘Spray-on Skin’ Device for Healing Burn Wounds

The UK's National Institute for Health and Care Excellence (NICE) has opened its consultation on draft guidance for a ‘spray-on skin’ device that aims to help improve the healing of acute burns.

EU Launch of Medicrea’s UNiD World First Patient-Specific Spinal Rod

By manufacturing customized implants, specifically pre-contoured using x-rays and proprietary software, surgeons can perfectly execute their surgical plans and accurately restore the sagittal alignment specific to each patient.

Perfusion System On Track to Replace Cold Storage of Donor Hearts

PROCEED II heart transplant FDA pivotal trial results using the Organ Care System (OCS™) Heart platform have been presented at the International Society for Heart and Lung Transplantation (ISHLT) 34th Annual Meeting and Scientific Sessions in San Diego, California.

CoreValve Injunction a Win for Edwards in Next Round of TAVI Patent Battle

Late last week Edwards Lifesciences announced that the U.S. District Court for the District of Delaware had granted a preliminary injunction, limiting the sale of Medtronic's CoreValve system in the United States. The court ordered the injunction to go into effect in seven business days.