A Medical Device Daily

NeuroLogica (Danvers, Massachusetts), a maker of portable medical imaging equipment, said that ANVISA: National Health Surveillance Agency (charged with ensuring the safety of medical devices in Brazil) has granted marketing approval for its portable CT scanner, CereTom.

The CereTom is a portable eight-slice CT scanner that can be used in the ICU, ER, OR, NICU, MICU, SICU, interventional suite, or any medical clinic. The CereTom is compact and lightweight; only 29 inches (74 cm) deep, five feet (153 cm) tall and four feet (134 cm) wide and weighs approximately 750 pounds (341kg).

"We are extremely pleased with this new approval in Brazil. The CereTom will now be poised and ready to help save lives in this corner of the world." said Eric Bailey, president/CEO of NeuroLogica. "We believe the performance and convenience of our portable CT scanner will make a positive contribution to the quality of healthcare throughout the largest country in South America, Brazil."

Dr. Colin McDonald, chief medical officer of Neurologica added, "Brazil has long been known as a Center of Neuro Excellence. We are happy to provide this dedicated group of neurocritical care professionals another useful tool in the battle against permanent brain injury."

The Ceretom was required to pass rigorous safety testing by ANVISA prior to approval. In addition, NeuroLogica's design and manufacturing systems previously demonstrated compliance with ISO 13485 International Quality System Requirements for Medical Devices and the FDA Quality System Regulations.

CMS Medical, based in Brazil, is the local representative/distributor for the CereTom.

CMT completes independent investigation

China Medical Technologies (CMT; Beijing), a China-based medical device company that develops advanced in vitro diagnostic (IVD) products reported the substantial completion of an independent internal investigation

CMT develops advanced IVD products using Enhanced Chemiluminescence technology, Fluorescent in situ Hybridization (FISH) technology and Surface Plasmon Resonance (SPR) technology to detect and monitor various diseases and disorders.

An anonymous letter was received by the company's audit committee. In this letter, allegations of irregularities and improper conduct were made against the senior management of the company in connection with its acquisitions of FISH and SPR, the company's disposal of its high intensity focused ultrasound tumor therapy system business and its revenues as well as its relationships with stock analysts.

The audit committee, consisting of three independent directors, decided to initiate an independent internal investigation into the allegations contained in the anonymous letter. In connection with this independent internal investigation, the audit committee engaged an independent law firm, Paul, Weiss, Rifkind, Wharton & Garrison, as well as independent forensic accountants, AlixPartners, to assist the audit committee to carry out this independent internal investigation. The independent law firm and forensic accountants involved their experienced personnel from their U.S. offices to conduct this independent internal investigation and began their investigative work in April 2009 and the investigation lasted for more than three months. The investigation covered not only the entire senior management team but also employees from various key departments of all operating subsidiaries of the company. The senior management and other relevant employees of the company fully cooperated with the independent law firm and forensic accountants in the course of the investigation. During the process of the investigation, the independent law firm reported from time to time the scope, procedures and progress of the investigation to the audit committee. The independent law firm and forensic accountants have substantially completed their investigative work and have reported to the audit committee that the investigation has not identified evidence to support the allegations made in the anonymous letter.

Xiaodong Wu, the chairman/CEO of the company said, "The entire senior management team is pleased that the independent internal investigation is substantially complete and that it has found no evidence supporting the anonymous allegations. We can now focus our efforts back to the operations of the company. We are confident that we will able to address the impact of this independent internal investigation on the timing of our financial reporting and other aspects of our operations and most importantly, the company's fundamentals remain healthy."

Due to the company's limited staff resources, it was not able to commence its work relating to the audit of the financial statements for its fiscal year ended March 31, 2009, which was originally scheduled to begin in May 2009. As the investigation is substantially complete, the relevant management members will start their work relating to the annual audit. The company said it expects to meet the deadline to file the company's annual report on Form 20-F by Sept. 30, 2009.

The company said it expects to announce in late August the unaudited financial results for the quarter and fiscal year ended March 31, together with the unaudited financial results for the quarter ended June 30.