Arobella Medical gets ISO certification

Arobella Medical (Minneapolis) reported the achievement of ISO 13485:2003 certification for the design, development, manufacturing, test, and delivery of medical devices. This certification, developed by the International Organization for Standardization (ISO), is the regulatory standard for the international medical industry and is closely related to ISO 9000 and EN 46000. Receiving the certification proves that the design, development and manufacturing functions at Arobella Medical meet the highest quality internationally recognized standards known for medical devices.

Arobella Medical produces the Qoustic Wound Therapy System, a wound therapy device that applies low-frequency, cavitational ultrasound to gently remove dead and diseased tissue cells, kill harmful bacteria and biofilm, and leave healthy and pre-healing granulation tissue intact.

New data support ExAblate 2000 MRgFUS

GE Healthcare (Waukesha, Wisconsin) and InSightec (Tirat Carmel, Israel) said that new data show that the non-invasive ExAblate 2000 Magnetic Resonance-guided Focused Ultrasound (MRgFUS) system is more cost-effective than myomectomy or uterine artery embolization (UAE). The study appears in the January issue of the International Journal of Technology Assessment in Health Care.

ExAblate 2000 is currently used commercially as a treatment for symptomatic uterine fibroids. The ExAblate procedure takes about three to four hours and normally allows the patient to go home the same day and return to normal activities within a day or two.

Hysterectomy, the most common treatment for this condition, is a major surgery, requiring two to five days of hospitalization plus six to eight weeks of recovery, and generating significant complications. Many women have chosen to suffer from the severe symptoms that fibroids cause rather than undergo hysterectomies or other invasive procedures.