A Medical Device Daily

The European Commission (EC) and the FDA have agreed to new confidentiality arrangements, which they say will lead to better health protection and easier trade between the European Union and the U.S.

Under the new arrangements, which were agreed to during a meeting last week in Brussels, the EC and the U.S. government will from now on be able to exchange confidential information about the safety of cosmetics and medical devices.

"We agreed to put in place a new framework for transatlantic economic integration," said European Commission Vice President Günter Verheugen, European chairman of the Transatlantic Economic Council (TEC) and commissioner for enterprise and industry policy. "I'm pleased to see that our ongoing cooperation with U.S. regulators is delivering tangible results for our citizens and businesses."

He added: "The EU and U.S. will be able to exchange early information to protect public health, [while] taking away stumbling blocks for trade."

Verheugen said that, for instance, in the field of cosmetics, "[this] agreement represents an important step toward our goal of accepting each other's alternative methods to animal testing."

Closer economic cooperation is the main aim of the TEC, which was launched late last month in Berlin. The group's work program covers cooperation initiatives to harmonize standards and improve trade in the areas of regulatory cooperation, Intellectual property rights, secure trade, financial markets, innovation and technology, and investment.

The types of information covered under the new confidentiality arrangements include:

  • Advance drafts of legislation and/or regulatory guidance documents.
  • Post-marketing data and information that could have an impact on the public health, such as vigilance data or information about impending regulatory actions.
  • Information on ongoing and emerging regulatory issues of health and safety in the U.S. or the EU.

3 firms collaborate on diagnostic device

Acrongenomics (Geneva, Switzerland), Molecular Vision (London) and Pearson Matthews (Kingston upon Thames, UK) reported that they have joined forces to design a prototype point-of-care medical diagnostic device suitable for detecting kidney and cardiac biomarkers.

The basis for the device will be the proprietary Molecular Vision technology that uses organic light emitters and photodetectors, coupled with microfluidics for the detection of biomarkers in bodily fluids. The technology was first demonstrated in March.

The diagnosis relies on the optical characterization of labeled biomarker molecules and can use fluorescence, absorption, chemiluminesence or any of the other usual optical detection methods.

Chris Wright, executive chairman of Molecular Vision, said, "We are looking forward to working with Pearson Matthews and Acrongenomics on the development of our first commercial product. In combination, the three of us are able to provide innovative technology, product design and access to the market place."

Molecular Vision, a spin-out company of Imperial Innovations , was founded by three Imperial College London researchers — Professor Donal Bradley, Professor Andrew de Mello and Dr. John de Mello — in 2002 in order to meet the need in the medical diagnostics, biosensors and analytical instrumentations markets for miniaturized chemical and biological detectors offering high sensitivity and functionality at low cost.

The company said it has addressed the market by inventing a method for optical detection based on recent advances in organic electronics and light-emitting diodes combined with microfluidics technology. Molecular Vision signed a development contract with Acrongenomics to jointly exploit and commercialize the technology.

Pearson Matthews is a specialist design development company with 20 years of healthcare sector experience for companies in the U.S. and Europe.

Värmland adding two Sectra systems

Sectra (Link ping, Sweden) reported that Värmland County Council in Sweden is expanding the digitalization of its mammography operations by investing in the company's Sectra MicroDose mammography systems, which it said has the market's lowest radiation dose.

The county council has used Sectra MicroDose mammography since 2006 and is now expanding its focus on digital mammography by buying two additional low-dose systems from Sectra.

"Sectra's mammography equipment provides us with a safe, ergonomic and efficient way of working, which will enable us to successfully manage our expanded focus on mammography-based medical examinations," said Birgitta Andersson, head of mammography operations in Värmland.

With the new equipment in place, the Värmland council expects a substantial increase in the number of women who can be called for mammography screening each year.

"Such a considerable flow of patients also imposes major demands on the equipment in terms of service and maintenance, and Sectra has a well-developed organization to cope with this," Andersson said.

More than 900 hospitals worldwide use the Sectra system and more than 40 million radiology examinations are diagnosed annually. The company was founded in 1978 and has its roots in the Link ping Institute of Technology .