A Medical Device Daily

Cardiola (Winterthur, Switzerland) reported that it has raised an additional $4 million from existing and new investors. Together with the $2.3 million raised earlier this year, the total cash infusion of $6.3 million is part of the first tranche of a $7.9 million Series E financing round. The proceeds are being used to commercialize in Europe the company's patented m.pulse device designed to non-surgically treat chronic heart failure (CHF) in a patient's home.

CHF is the most frequent cause of hospitalization in persons aged 65 and older. Current treatments, including drugs, implantable defibrillators/pumps and heart transplantation, have significant risks and side effects. Cardiola's m.pulse device, based on Muscular CounterPulsation (MCP) technology, is approved in Europe for treating CHF as a non-surgical, at-home therapy. Battery-powered m.pulse, the size of a cell phone that the patient attaches to his belt for about 45 minutes per treatment, is synchronized to his cardiac cycle to stimulate the muscles of the calves and thighs to make them contract counter to the heart's beating. This well-established counterpulsation action results in increased blood flow to the heart muscle while decreasing the heart's workload.

Ellipse gets CE mark for Magec system

Ellipse Technologies (Irvine, California) said it has received the CE mark for its Magec technology for the treatment of spinal deformity. The first application for this technology is for the treatment of spinal scoliosis in young children and teenagers.

Ellipse has developed the technology for minimally invasive, and ultimately, non-invasive, orthopedic deformity prevention and management. Ellipse has filed numerous patent applications for the use of the technology for a broad range of clinical applications. The company is currently concentrating on spinal and orthopedic trauma applications. The company describes the technology as a "breakthrough medical device technology capable of non-invasively adjusting implants within the human body from outside the body via remote control."

Currently, young children, pre-teenagers and teenagers with spinal scoliosis have few medical options. The standard treatment requires a series of five to ten highly invasive surgical operations with large surgical incisions and long recovery times performed over a number of years – a process so undesirable that 67% of the diagnosed patients refuse the surgical option.

With the Magec technology, a single minimally invasive surgical procedure is completed. Then, during a series of simple outpatient visits, the physician will dynamically adjust the Magec technology from outside the body via the Magec system's control unit, thus eliminating the need for multiple highly invasive surgical procedures. The system is designed to provide for spinal motion preservation, no long term permanent implant, and minimal trauma and scarring.

EDDA earns CE mark for IQQA-Liver

EDDA Technology (Princeton, New Jersey) reported that it received the CE mark for its new release of IQQA-Liver, an advanced clinical application designed to enhance efficiency and precision in liver imaging evaluation and treatment planning.

IQQA-Liver provides a comprehensive toolset for highly automated quantitative volumetric evaluation of liver, liver lobes and segments, hepatic lesions, and vascular structures including artery, portal veins and hepatic veins from CT data.

Through EDDA's proprietary IQQA PACS- and web-enabling technology, IQQA-Liver can be readily deployed onto any existing hospital PACS workstations or via the web so that data evaluation and treatment planning results can be shared quickly anywhere anytime among authorized physicians.

EDDA is a clinical computer solution provider in diagnostic imaging and analysis. It offers a series of new generation software products to enable early detection of diseases, and enhance efficiency and precision in diagnosis and treatment.