Breathe 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 is sounding punchy, expecting revenue gains based on a flurry of new product approvals.
ulrich medical USA, Inc., has announced the U.S. market release of its tezo® spine implants for multiple surgical approaches to lumbosacral interbody fusion.
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.
Covidien 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.
ROX 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 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.
Covidien 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.
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.
Boston 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.
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.
The UK's National Institute for Health and Care Excellence (NICE) has opened its consultation on draft guidance for a ‘spray-on skin’ device that aims to help improve the healing of acute burns.
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.
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.
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.