A Medical Device Daily

US Spine (Boca Raton, Florida) said it has received CE-mark certification for the commercial sale of its technology in Europe, indicating that the company has met the essential health, safety and performance protection requirements detailed in the European Medical Device Directive 93/42/EEC.

The company also said it has been certified to ISO13485:2003 and ISO 9001:2000 by LNE GMED, a certification and notification body, after a comprehensive audit of US Spine's quality management system.

The ISO certifications are internationally recognized medical device quality management system standards developed by the International Standards Organization.

"Receiving our ISO certifications and CE-mark approval are exciting steps forward in providing European surgeons and patients with our next generation of spine technology," said President/CEO Doris Blake. "Our Facet Fixation technology is ushering in a new type of posterior fixation that allows surgeons to create a rigid posterior construct in a fraction of the time required by conventional devices."

She added, "We've introduced the concept of a facet bolt as well as providing surgeons with an implant that is preloaded into the delivery mechanism. With our technology providing faster, easier to use and potentially better patient outcomes, it has already been enthusiastically embraced by the surgery communities here in the U.S. and we anticipate a similar response abroad."

US Spine is focused on the development and commercialization of advanced spinal implant systems with "breakthrough technology" to address the rapidly increasing spine implant market. It said its development efforts are centered on motion and tissue preservation through the use of advanced biomaterials and expert surgeon designers.

The future of care and support in London

UK Care Services Minister Phil Hope is holding public consultations on the future of the care and support system in England, particularly in the London area.

In 20 years, the number of people living in Greater London over the age of 65 will have risen to more than 1 million, and the number of people over 85 will have risen to over 140,000.

The engagement on the future of care and support involves members of the public, people who use services and their families joining Hope to discuss their views on what kind of system they want to see in the future, as well as how it should be funded.

Hope said, "At the turn of the century there were 19 people working for every one retired. That number has now decreased to four working for every one retired. It's vital [that] I discuss, with the people of London, how we can create a high-quality, affordable care and support system for a rapidly aging population."

He added, "The care and support system for the future should promote independence, choice and control for everyone. We are committed to creating a system in the future that meets the individual needs of our ageing population and their families. I urge people to get involved — the reform affects us all."

Hope said that in 20 years' time a quarter of the entire adult population in England will be over 65 and the number of people over 85 will have doubled. "We expect over 1.7 million more people to have care and support needs [then]," he said.

FDA okays Austrian firm's product

CNSystems Medizintechnik (Graz, Austria) said it has received FDA clearance for CNSystem's CNAP Monitor 500, permitting the sale of the product in the U.S. The CNAP Monitor 500 measures non-invasive and continuous blood pressure in real-time and can predict responsiveness to fluid administration.

In the perioperative setting, detecting blood pressure drops and their cause in time is crucial for peri- and postoperative outcome. However, until recently only invasive methods provided quality information to the clinician.

CNSystems said CNAP provides reliable blood pressure monitoring comparable to invasive techniques and adds valuable information about fluid responsiveness of the patient non-invasively. It said this allows spreading the highest level of blood pressure monitoring to all perioperative settings where close blood pressure monitoring is indicated, but the risk and discomfort of invasive measurement is not justified.

Misonix signs another distributor

Misonix (Farmingdale, New York) reported the signing of another European distributor, Eclipse Medical (Rotterdam, the Netherlands).

The three-year, exclusive distribution agreement allows Eclipse Medical to distribute the SonaStar Ultrasonic Surgical Aspirator, the BoneScalpel Ultrasonic Bone Cutter, and the SonicOne Ultrasonic Wound Debrider in the Netherlands.

Misonix said Eclipse Medical has built a solid reputation as a distributor of medical devices and capital equipment, with special emphasis on surgery and oncology.