News and Information

FDA Recognizes AAMI Version of Electrical Equipment Standard

The U.S. Food and Drug Administration (FDA) has formally recognized the Association for the Advancement of Medical Instrumentation (AAMI) version of an international standard on medical electrical equipment.

FDA’s recognition of ANSI/AAMI ES60601-1:2005 — Medical electrical equipment, Part 1: General requirements for basic safety and essential performance and other collateral standards — comes as welcome news to the medical technology community.

The standard — which is the U.S. adoption of IEC 60601-1/Ed.3:2006 — contains required national deviations to comply with the National Electrical Safety Code, says Charles Sidebottom, director of corporate standards for Minneapolis-based Medtronic and secretary of IEC/Subcommittee 62A, which developed the IEC standard.

Midmark Announces Launch of Two New IQ Devices

Expanding its diagnostic product offering with IQvitals™ and IQvitals™ PC automated vital signs devices

VERSAILLES, Ohio – (August 2, 2010) – Midmark Corporation, the industry leader in integrated digital diagnostic devices for ambulatory care, announced the launch of IQvitals™ and IQvitals™ PC automated vital signs devices.

IQvitals is an automated vital signs device, based on the Windows® CE operating system, that measures noninvasive blood pressure, heart rate, and body temperature. It features a full color touch screen with an easy-to-use, intuitive user interface including multiple dedicated, one-touch operating controls and a QWERTY keyboard for patient data entry. IQvitals is a lightweight, highly portable device with an internal battery that supports up to eight hours of operation before requiring recharge. It may be used as a standalone device or in conjunction with Midmark’s proprietary IQmanager™ software for digital data collection and management.

Hologic Completes Acquisition of Sentinelle Medical

BEDFORD, Mass., Aug. 5 /PRNewswire-FirstCall/ -- Hologic, Inc. (Hologic or the Company) (Nasdaq: HOLX), a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, announced today the completion of its acquisition of Sentinelle Medical Inc. (Sentinelle Medical), a leading provider of Magnetic Resonance Imaging (MRI) breast coils, tables and visualization software.

"We are extremely pleased we have finalized the acquisition of Sentinelle Medical," said Rob Cascella, President and Chief Executive Officer. "We believe MRI will be an important standard of care for breast screening of women indicated as having a high risk of developing the disease. Adding Sentinelle Medical's products to Hologic's best-in-class portfolio of product offerings in the areas of breast cancer detection and intervention will enhance our Company's presence as a leader in women's healthcare."

Baxter to Recall COLLEAGUE Infusion Pumps in U.S.

DEERFIELD, Ill, May 3, 2010 - Baxter Healthcare Corporation today announced that it will recall COLLEAGUE infusion pumps from the U.S. market pursuant to an order under its existing June 2006 consent decree with the U.S. Food and Drug Administration (FDA). Baxter will work with the FDA to ensure that the recall process provides customers appropriate alternatives for supporting patients' needs.

As previously disclosed, Baxter entered into a consent decree with FDA under which the company has been pursuing remediation of the infusion pumps. The decree permits FDA to require the recall of the pumps, and FDA has communicated to the company that it will require such a recall, with the company providing monetary consideration or replacement pumps to customers on a timeline to be determined with FDA and based on medical need. Baxter intends to work with FDA to minimize disruption to healthcare facilities using COLLEAGUE pumps. Baxter anticipates that, among alternatives to be provided to customers, the company will offer to exchange Baxter's Sigma SPECTRUM infusion pumps for COLLEAGUE infusion pumps without charge to customers.

The consent decree permits Baxter to propose alternative actions to achieve the FDA's objectives under the decree, which the company intends to do. The final nature of the recall and offer to customers remain subject to that ongoing dialogue. Once final, Baxter will notify customers and make information available on www.baxter.com.

Notwithstanding that uncertainty, the company currently anticipates that it will record a pre-tax special charge of $400 to $600 million in the first quarter for the reasonably estimable cost of the recall. The company is not otherwise revising its earnings guidance for the year in connection with the recall.

 

About Baxter

Baxter Healthcare Corporation is the principal domestic operating subsidiary of Baxter International Inc. (NYSE: BAX). Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

This release includes forward-looking statements concerning the Company's recall of its COLLEAGUE infusion pumps from the U.S. market, including expectations with respect to the implementation of the recall and the amount of the related charge. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: resolution of the final nature of the recall; future actions of the FDA with respect to the Company's implementation of the recall pursuant to the Consent decree, including any sanctions available under the Consent Decree; future actions of the FDA or any other regulatory body or government authority that could delay, limit or suspend product development, manufacturing or sale or result in seizures, injunctions, monetary sanctions or criminal or civil liabilities; product quality or patient safety issues; the financial impact of the recall; and other risks identified in the company's most recent filing on Form 10-K and other SEC filings, all of which are available on the company's website. The company does not undertake to update its forward-looking statements.

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