A Medical Device Daily

Resuscitation device maker Zoll Medical (Chelmsford, Massachusetts) reported that it has received a Medical Device License from Health Canada for its R Series, which Zoll said is the first and only "Code-Ready" defibrillator that can help improve in-hospital resuscitation efforts.

The license provides the necessary approval for Canadian marketing and sale of the device.

Richard Packer, president/CEO of Zoll, said, "We define 'Code-Ready' as a device that is simple and always ready to use. The R Series offers a OneStep system that simplifies and speeds up deployment of pacing and defibrillation therapy. It also offers comprehensive, automated readiness checks designed to maximize the readiness of the R Series to help clinicians when they need it most."

He added, "This new device is an important step in continuing Zoll's growth in North America."

In a press statement, the company said the R Series also offers tools to help clinicians with CPR performance, "which is important because more than half of in-hospital codes involve non-shockable rhythms and, in such cases, the only treatment for these rhythms is high-quality CPR with minimal interruptions."

The R Series also offers See-Thru CPR functionality that helps clinicians reduce interruptions. While clinicians are viewing the ECG on a monitor/defibrillator, artifact (i.e., "noise") from manual chest compressions makes it difficult to discern the presence of an organized heart rhythm unless compressions are halted. See-Thru CPR filters out this artifact so that clinicians can view an underlying rhythm without stopping chest compressions.

A visual aid known as the CPR Index that allows clinicians to see how well they are performing the rate and depth of chest compressions in real time. This index, along with optional audible prompts such as "Push Harder" and "Good Compressions," helps clinicians improve CPR performance by integrating rate and depth into a single indicator, Zoll said. With such feedback, clinicians know how well they are performing compressions and can quickly adjust their compressions to improve blood flow.

All CPR performance data and the entire resuscitation record, including the ECG, can be downloaded into Zoll CodeNet and reviewed for quality assurance and training purposes. Zoll said CodeNet is the first system to help document, review and manage a complete set of data for in-hospital resuscitation events, including both code-event data and defibrillator data, on one synchronized timeline.

The R Series also checks more than 40 measures of readiness, including the presence of the correct cables and electrodes, the type of electrode and other important electronics.

Zoll sells its products in more than 140 countries via a combination of direct operations, distributor networks and business partners.

Affymetrix, Sysmex in distribution, other accords

Affymetrix (Santa Clara, California) said it has signed two agreements with Sysmex (Kobe, Japan) to distribute, develop and market in vitro diagnostic tests. Sysmex has exclusive rights to distribute Affymetrix's diagnostic microarray products and instrumentation in Japan, with the opportunity to expand into certain Asia-Pacific countries.

In addition, a Powered by Affymetrix agreement gives Sysmex non-exclusive access to Affymetrix microarray technology to develop and market in vitro diagnostic tests on a worldwide basis.

Sysmex will carry out all registration, sales and customer support activities for the diagnostic instrumentation, array and reagent products as the Affymetrix distributor in Japan.

The Japanese company globally markets diagnostic systems for hematology, coagulation and immunochemistry testing and recently launched a system for detection of breast cancer lymph node metastasis.

The Powered by Affymetrix agreement enables Sysmex to incorporate Affymetrix arrays into its diagnostic products. The companies said that the resulting microarray-based tests will enable clinicians to provide more efficient and complete methods to diagnose, classify and manage these disorders.

"We are very pleased that Sysmex, with its strong reputation for product quality and customer support, will represent our growing line of diagnostic products in such an important region of the world," said Noel Doheny, senior vice president, molecular diagnostics at Affymetrix. "Sysmex shares our vision of enabling the personalization of medicine through high-value, content-rich tests."

The Affymetrix line of products includes the GeneChip System 3000Dx (GCS3000Dx), which it calls the first microarray instrumentation system for molecular diagnostic laboratories. The GCS3000Dx has been granted regulatory clearance by the FDA and is CE-marked for in vitro diagnostic use.

Affymetrix and its Powered by Affymetrix partners are developing array-based tests for use with this system.

Bruker sets AXS unit for Australia

Bruker Biosciences (Billerica, Massachusetts) said it was set to launch a new Bruker AXS (Madison, Wisconsin) business in Australia Jan. 1.

Bruker AXS is a developer and provider of life science, materials research and industrial X-ray analysis tools and has previously been represented in Australia by its longstanding distributor, Sietronics.

The company's AXS business unit is being established with headquarters in Melbourne to take it forward in the Australian market with a large installed instrument base and the Bruker AXS brand name.

To ensure continuity for existing customers, Bruker AXS said it has secured business management and service resources from the former distributor. With trained personnel as a result of these recruitments, the company, based in Western Australia, Victoria and New South Wales, will deliver support to its existing customers and will grow its presence in the rapidly expanding X-ray diffraction, X-ray fluorescence and optical emission spectrometers markets.

"After many years of excellent representation by Sietronics, we are delighted to be able to expand our presence directly in the Australian market. We have ensured that our large range of innovative industrial and academic XRD, XRF and OES products are backed by first-class local service and application support and we believe that our direct commitment to the Australian market will yield increased customer satisfaction and market share," said Bernd Masling, sales director of Bruker AXS.

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