Boston Scientific gets FDA green light for bare-metal stent | Illumina receives $1.5M in tax breaks in San Diego | Firms jointly develop next-generation sequencing tech
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July 22, 2014
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Boston Scientific gets FDA green light for bare-metal stent
The FDA has granted Boston Scientific approval to market a bare-metal stent built out of the same architecture and platinum chromium material used with the company's Promus Premier stent. The Rebel stent offers a treatment alternative for patients who aren't eligible for drug-eluting stent therapy. (Boston) (7/21)
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Business & Market Trends
Illumina receives $1.5M in tax breaks in San Diego
San Diego has agreed to provide Illumina with tax incentives worth $1.5 million over a period of 10 years, keeping the medical device company and its 1,400 jobs in the city. Illumina is also planning a facility expansion that could generate 300 more jobs in the area. KUSI-TV (San Diego) (7/22)
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Firms jointly develop next-generation sequencing tech
Illumina and Berry Genomics have created a next-generation sequencing tool that combines Berry's Bambni noninvasive prenatal assay with Illumina's NextSeq 500 system. The companies are now in the process of obtaining approval for clinical use of the sequencing technology in China. GenomeWeb Daily News (free registration) (7/21)
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Pain management device firm gets new CFO
Brian Alleman has been appointed to replace Anthony Scalese as chief financial officer of Zynex, a maker of noninvasive devices for stroke rehabilitation, pain management and other applications. Alleman comes to Zynex from Alleman & Associates, where he served as managing director. American City Business Journals/Denver (7/21)
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International Developments
New U.K. committee aims to improve access to medtech specialist advice
The U.K. is creating the new independent Devices Expert Advisory Committee to increase its access to scientific expertise about device regulation. The DEAC will replace the Committee on the Safety of Devices and is expected to be more responsive and quick in obtaining advice on complex issues from the clinical community. Clinica (7/21)
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Companies in Italy must register certain IVD medical devices in national database
New rules require IVD companies operating in Italy to register their products in the Repertorio national database of medical devices in order to participate in public tenders. Products subject to the new rule include self-testing IVDs and such IVD tests as HIV, blood grouping and self-test blood glucose monitoring. IVD manufacturers hope that an imminent upgrade of the registration part of Eudamed, the European medical device database, will make the Repertorio unnecessary, according to the European Diagnostic Manufacturers Association. Clinica (7/21)
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Science & Health
Study of Medrobotics' surgical robot kicks off in Germany
Doctors at a hospital in Germany were the first to use Medrobotics' Flex surgical robot to successfully remove cancerous lesions in two patients. The surgery is part of a postmarket clinical study evaluating the use of the device in accessing and viewing structures in the throat and mouth. The trial will involve as many as 80 patients in Belgium and Germany. (Boston) (7/21)
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ConforMIS' device fares better than standard implants in TKA study
A clinical study found that patients treated with the ConforMIS iTotal personalized knee implant had lower hospital costs, fewer adverse events and reduced blood-transfusion rates compared with those who received off-the-shelf implants. The findings were based on a retrospective study of 248 patients hospitalized for total knee arthroplasty. (7/21)
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Emerging Technologies
Soft-tissue transponder from Varian Medical wins FDA nod
Varian Medical Systems has been cleared by the FDA to market its Calypso Beacon transponder, which the company said can be inserted inside soft tissue anywhere in the body except in the lungs. The device is used with the company's Calypso GPS for the Body real-time tracking system to allow doctors to target tumors precisely during radiosurgery and radiotherapy. (free registration) (7/21)
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Featured Press Releases
Government & Regulatory
Sunshine Act disclosure website marred by glitches, reports say
Early reports show some glitches with the Open Payments website, the federal database designed to show doctor payments from drugmakers and medtech firms under the Physician Payments Sunshine Act. Some doctors are taking an hour or more to log in and verify their identities. "I am still uncertain, despite arriving at the exit screen, whether error means no pharma reports or HHS [has] a bug to repair," said Dr. Bradley Flansbaum, a hospitalist at New York City's Lenox Hill Hospital. ProPublica (7/21)
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