Verax receives ISO certificatio

Verax Biomedical (Worcester, Massachusetts), a developer of rapid tests for detecting bacterial contaminants in blood cells and tissue, has received ISO 13485:2003 certification. ISO is a quality management standard that represents independent confirmation that the company has implemented an effective quality management system that addresses all areas of its operations including the design, development and manufacturing of its products.

ISO certification clears the way for the marketing of Verax-manufactured products in the world market.

Verax Biomedical’s primary product is the Platelet PGD Test, a disposable device designed to detect the presence of a range of bacterial contaminants in platelets at a later phase in platelet unit life than current culture methods.

Brava reconstruction system tested

Roger Khouri, MD, a noted plastic and reconstructive surgeon, is leading a team of surgeons in a clinical trial performing a minimally invasive breast reconstruction technique using the Brava (Miami) external expansion system and liposuctioned micro-fat grafts primarily on women who have had a mastectomy or lumpectomy, with or without radiation therapy.

CMS releases new coding rates

The Centers for Medicare and Medicaid Services (CMS; Washington) has released an advance copy of CMS-1392-P Proposed Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2008 Payment Rates. The proposed rule is expected to be published in the Federal Register in late October.

CMS proposes to reassign the PET/CT codes from APC 1511 — New Technology-Level XI to APC 0308 — Non-Myocardial PET imaging. Therefore all the non-cardiac PET CPT codes would be assigned to a single APC 0308, with a new payment rate of $1,107.22.

CyberKnife Center to open in Tampa

The first of its kind in the Tampa area, the CyberKnife Center of Tampa Bay (Tampa, Florida) will break ground in January 2008, and is scheduled to be operational by summer.

The center, developed and operated by Tampa Bay Radiosurgical Associates, will operate as an “open” treatment center. It will be used by a large number of physicians from various institutions and practices, in order to provide whole-body radiosurgery treatment to the broadest number of patients.

The CyberKnife uses “image-guided” technology that is integrated with robotics to deliver higher doses of targeted radiation to cancerous tumors almost anywhere in the body. It is proven to be effective in treating head, neck, spine, prostate, liver, lung and pancreatic cancers, as well as other tumors.