March’s top stories: Baxter to split, first migraine device gets FDA clearance

Baxter revealed its plans to split itself into two separate and independent entities, while Cefaly Technology obtained FDA clearance for its device for preventative treatment of migraine headaches. Medicaldevice-network.com wraps-up the key headlines from March 2014.


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Baxter to split into medtech and pharma companies by mid-2015

US-based Baxter International revealed its plans to split itself into two separate and independent entities, one focusing on medical products and the other developing and marketing innovative biopharmaceuticals.

Baxter has positioned both businesses to be successful, profitable and sustainable independent companies and believes that it can tap more value and growth potential by splitting into two entities instead of in a larger, multifaceted organisation.

The move will create two, well-capitalised independent companies with strong balance sheets, investment grade profiles, and disciplined approaches to capital allocation.

GE Healthcare introduces new economical PET/CT system for early cancer detection


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GE Healthcare introduced Discover IQ, an advanced positron emission tomography/ computed tomography (PET/CT) molecular imaging system designed in India for worldwide use.

Developed at a cost of $15m, the new Discover IQ is the result of three years of close collaborations with Indian nuclear medicine physicians and oncologists.

GE Healthcare South Asia president and CEO Terri Bresenham said three years back, the company agreed to develop an advanced and cost-effective PET/CT to improve access to early cancer detection.

Covidien closes acquisition of Given Imaging

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Medical devices manufacturer Covidien closed its $860m buyout of the Israeli company Given Imaging, providing the company additional scale and scope to serve a significant medical specialty in the multibillion dollar global gastrointestinal (GI) market.

This acquisition boosts the company's strategy to comprehensively address key global specialties and procedures.

Under terms of the agreement, Covidien has acquired all outstanding Given shares for $30 per share or an aggregate consideration of approximately $860m, net of cash and short-term investments acquired.

NIRF Imaging and Exelis form diagnostic technology alliance

US-based NIRF Imaging and Exelis joined forces to develop and market a near-infrared fluorescence imaging technology for point-of-care diagnostic applications.

Under the terms of agreement, Exelis will provide NIRF Imaging with its proprietary Pinnacle Gen III image intensifier (I2) tubes, which have historically been used primarily in military-grade night-vision goggles, for use as a key component in NIRF Imaging's proprietary medical imaging technology.

According to the company, the ability to provide a 'ready-now' technology such as Pinnacle was a key factor in selecting Exelis as a partner.

First migraine prevention device gets FDA approval

Belgium-based Cefaly Technology received US Food and Drug Administration (FDA) approval for its device for preventative treatment of migraine headaches.

It is claimed to be the first medical device to receive marketing approval in the US for the treatment for migraine headaches and it is also the first transcutaneous electrical nerve stimulation (TENS) device specifically authorised for use prior to the onset of pain.

Manufactured by STX-Med in Herstal, Liege, Belgium, Cefaly is a small, portable, battery-powered plastic headband worn across the forehead with a self-adhesive electrode.

Staar Surgical's Visian ICL with CentraFLOW technology wins Japanese approval


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US firm Staar Surgical obtained regulatory clearance from the Japanese Ministry of Health, Labour and Welfare to market its Visian implantable collamer lens (ICL) with CentraFLOW technology.

The regulatory clearance for the Visian ICL with CentraFLOW will now be expanded to include not only the technology, but also expands the treatment of myopic down to -3.0 diopters as compared with the current range which starts at -5.0 diopters.

CentraFLOW technology optimises fluid flow in the eye by using the KS-AquaPORT technology in the centre of the ICL optic.

Biotronik's ultra-tiny MRI-safe CRT lead obtains CE Mark clearance


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Manufacturer of technology specialising in heart failure therapy, Biotronik, announced the European approval and the first implantations of its bipolar cardiac resynchronisation therapy lead Sentus ProMRI.

The company's bipolar cardiac resynchronisation therapy (CRT) lead is claimed to be the first MR conditional lead with a 4F diameter, approximately 1.6mm.

This ultra-thin lead allows clinicians with more pacing options to access hard-to-reach vessels.

European Patent Office revokes Edwards' Spenser patent

US-based Medtronic announced that the European Patent Office (EPO) has invalidated an Edwards' patent (EP2055266) that was used to prevent Medtronic from selling its CoreValve transcatheter aortic valve in Germany.

In its ruling, the EPO in The Hague said the entire patent is invalid and therefore has revoked it.

Medtronic senior vice-president and president of the Medtronic structural heart business Dr John Liddicoat said: "Medtronic is very pleased with this ruling as it will ensure that patients across Europe who need aortic valve replacement will have access to this life-saving therapy."