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Shimadzu receives FDA 510(k) for the FLUOROspeed X1 RF System

Shimadzu Medical Systems has received FDA 510(k) clearance for the FLUOROspeed X1, patient side conventional RF table system. Shimadzu has introduced a new radiographic/fluoroscopic (RF) system called the FLUOROspeed X1, a conventional RF table system offering high image quality and a multitude of features that improve work flow and operator efficiencies, which contribute to lower cost of care. As the newest US-based product in the FLUOROspeed series, the FLUOROspeed X1 with its 665 lb. static patient weight and 500 lb. all-motion weight, easily performs both bariatric and routine daily fluoroscopic and radiographic exams.

The X1 is an outstanding RF system offering a cost-effective balance of functionality to support a wide range of general RF applications, such as chest, abdomen, or extremities along with Upper GIs, modified swallows, and even joint injections. An ambidextrous control handle for the imaging deck along with fingertip access to APRs, image-recording functions, and site-specific programmable function buttons, are all standard on the new X1 RF system, all improving room workflow.

Boston Scientific completes acquisition of BTG
Boston Scientific has completed the acquisition of UK-based healthcare company BTG. In November 2018, Boston Scientific first announced a recommended offer to acquire BTG for USD 4.2 billion (£ 3.46 billion). Holders of BTG common shares will get 840 pence in cash per share, as per the terms of the previously announced transaction. BTG is involved in the development and commercialization of products used in minimally-invasive procedures targeting cancer and vascular diseases, as well as specialty pharmaceuticals. The company operates three major businesses, of which the interventional medicine portfolio is the largest segment.

The segment includes interventional oncology therapeutic technologies for patients with liver and kidney cancers, in addition to a vascular portfolio to treat deep vein thrombosis, pulmonary embolism, deep venous obstruction, and superficial venous disease. BTG portfolio is also comprised of specialty pharmaceutical business, which includes acute-care antidotes to treat overexposure to certain medications and toxins, as well as licensing business that secures royalties related to its intellectual property and product license agreements.

Boston Scientific also intends to complete the previously announced sale of its global embolic microspheres portfolio, including Embozene, Embozene Tandem, and Oncozene brands, to Varian Medical Systems. In July this year, Varian Medical agreed to purchase drug-loadable microsphere and bland embolic bead product portfolio from Boston Scientific for around USD 90 million (£ 71 million). Boston Scientific is also starting a process to explore the divestiture of the royalty stream associated with BTG’s Zytiga licensing arrangements and plans to close the deal by the end of this year.

Mike Mahoney
Chairman and CEO,
Boston Scientific“The addition of the BTG Interventional Medicine portfolio reinforces our category leadership strategy and enables us to offer best-in-class technologies, unparalleled clinical evidence, and a strengthened commercial infrastructure to support physicians treating some of the most challenging diseases impacting patient health around the world. Leveraging the employee talent and clinical and commercial expertise of these two high-performing organizations will generate continued innovation and access so that we may advance patient care in ways that neither company could do alone.”

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