A Medical Device Daily

Cardiff University's (Cardiff, Wales) School of Engineering has launched the Institute of Medical Engineering and Medical Physics, which it said provides “a framework for multidisciplinary research in applying engineering principles to solve problems in medicine and healthcare.“

The university said the new institute would place Wales at the forefront of medical engineering.

Ceremonies held last week marking the launch of the institute were highlighted by a lecture by Sir Peter Mansfield, the 2003 Nobel laureate for medicine for his pioneering development of magnetic resonance imaging (MRI) technology.

Mansfield recounted his early experiences with the development of MRI and the problems that had to be overcome in order to create the advanced medical imaging scanners in clinical use today.

The institute is currently working with industrial partners in the design, development and testing of orthopedic implants, the development of numerical models to analyze movement of human joints and the detection of deep vein thrombosis using novel imaging techniques.

The institute has access to its own MRI scanner and a wide range of ultrasound equipment used to image a variety of pathological conditions in order to develop new treatments.

Work also is being carried out with spinal surgeons to gain an understanding of the biomechanics of spinal instrumentation and spinal constructs.

The university said the institute features a fully equipped gait analysis laboratory incorporating high-speed cameras, being used for projects such as clinical trials to analyze knee function, investigation into head and arm injuries in infants, and human body response to blunt and sharp impacts.

In collaboration with area health authorities, the Institute of Medical Engineering and Medical Physics also is working on the design of wheelchair seats and the use of robotics in rehabilitation.

Aimed at providing a framework for multidisciplinary research in medical engineering and medical physics, the institute originally was established by the Cardiff School of Engineering and the Department of Clinical Engineering and Medical Physics at University Hospital of Wales (Cardiff) to provide a focal point and infrastructure for those working in medical engineering and medical physics and related fields.

The staff is drawn from a wide range of specialities, which reflect the multidisciplinary nature of the institute.

Cardiff University and the University of Wales College of Medicine merged last year. Prior to that, there was a long history of collaboration between the Cardiff School of Engineering, the Department of Medical Physics and Clinical Engineering and the College of Medicine in teaching and research.

Those involved say establishment of the institute has led to new collaborations between researchers throughout the university and is providing a focus for work in several “exciting new research areas.“

Crosser catheter gets CE mark

FlowCardia (Sunnyvale, California), a maker of catheter- based systems to treat chronic total occlusions (CTOs) of coronary and peripheral arteries, reported CE marking of the Crosser catheter for use in coronary arteries following failure to cross CTOs with conventional guidewire techniques.

CE mark approval allows the company to market the system in all member countries of the European Union (EU). FlowCardia added that many other countries outside of the EU recognize the CE mark for regulatory approval.

The Crosser System uses high-frequency mechanical vibration to safely and quickly cross CTOs, the company said, “allowing subsequent balloon angioplasty and/or stent placement and obviating the need for potentially traumatic cardiac surgery.“

FlowCardia received approval from the FDA in December to start the pivotal phase of its U.S. clinical trial for the Crosser system. The first patients in the pivotal study have been enrolled and the company expects that the trial will be completed and a request for 510(k) clearance from the FDA will be submitted in the second half of this year.

Nordic licensee for Sonomax system

Sonomax Hearing Healthcare (Montreal) said it has concluded an international licensing agreement for its industrial hearing protection line covering the Nordic countries of Denmark, Sweden, Finland and Norway. The exclusive licensee is Soundship Aps, a Danish company that develops and markets noise surveillance equipment used in hearing conservation programs throughout the European Union through a network of occupational health and safety professionals.

The two-year agreement is based on Sonomax granting exclusive right to sell and service Sonomax industrial hearing protection in the territory, in consideration of commitments that include an initial order equal to approximately C$100,000.

The licensee also will take financial responsibility for the testing, regulatory, training and insurance prerequisite costs of selling and marketing the product line within its jurisdiction.

Lars Bolt, managing director of Soundship Aps, said that the synergy of his firm's SoundEar noise monitoring system and the Sonomax Solution hearing protection system creates a solution that is complete and leaves no variables — such as not knowing that noise levels have reached dangerous thresholds or remaining unaware of unexpected change in noise level — to chance.“

He said his firm's market territory includes more than 2 million noise-exposed persons.

Soundship Aps has established a selling and support network of more than 25 industrial health/safety companies in seven EU countries.

Sonomax Hearing Healthcare manufactures an in-the-ear platform technology and SonoPass fitting software that allows its earpiece to be permanently customized to the exact shape of an ear, on the spot, in minutes.

Trading begins for Biofusion

Biofusion (Sheffield, UK) began trading recently following its initial public offering on London's Alternative Investment Market, raising pounds 8.2 million ($17.8 million).

The technology commercialization company has a 10-year exclusive deal to commercialize biological and medical research from Sheffield University.