Device / Technology News

RSS

Biodesix, Kadmon enter Phase 3 non-small cell lung cancer study collaboration

Biodesix Inc., a fully integrated molecular diagnostic company dedicated to personalizing medicine, today announced a collaboration with Kadmon Corporation, LLC, to explore the utility of Biodesix' VeriStrat® test in a Phase 3 non-small cell lung cancer (NSCLC) study of Kadmon's KD019, a reversible tyrosine kinase inhibitor (TKI) targeting EGFR, HER2, VEGFR2 & 3, and SRC.

27 Feb 2012

AB SCIEX granted ISO 13485 certification for quality management system.

AB SCIEX, a global leader in life science analytical technologies, today announced that it has achieved ISO 13485 certification for its quality management system. ISO 13485 is an international standard that requires a manufacturer to demonstrate a comprehensive and compliant quality management system suitable for the design and manufacturing of medical devices.

27 Feb 2012

FDA grants 510(k) clearance for Ventana Ki-67 image analysis algorithm

Ventana Medical Systems, Inc., a member of the Roche Group, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VENTANA Companion Algorithm Ki-67 (30-9) image analysis application used with the VENTANA iScan Coreo Au scanner running VIRTUOSO software.

27 Feb 2012

First patients in Germany treated with Delcath Hepatic CHEMOSAT Delivery System

Delcath Systems, Inc., announced today that the first patients in Germany have been treated with the Delcath Hepatic CHEMOSAT Delivery System at the Johann Wolfgang Goethe University Hospital, a premier European cancer treatment and research center located in Frankfurt. The cases were treated as part of the initial launch and training agreement the Company announced with the hospital in December 2011.

27 Feb 2012

New research report on the electrosurgical devices market

ReportsnReports adds new market research report 'Electrosurgical Devices Market - Global Pipeline Analysis, Competitive Landscape and Market Forecasts to 2018' to its store. The global electrosurgical devices market is expected to reach $1,412.8m by 2018 growing at a CAGR of 5%.

27 Feb 2012

BioConnections, Yissum to commercialize kits that detect MDR and XDR infections

Yissum, the research and development company of the Hebrew University of Jerusalem, had signed a licensing agreement with BioConnections, a UK based microbiology company, for the commercialization of kits that enables immediate detection of all multidrug resistant (MDR) and of any extremely drug resistant (XDR) infections.

27 Feb 2012

Aesculap, Osseon partner to distribute VCF treatment devices

Osseon Therapeutics, Inc. announced today that the company has entered into an International Distribution Agreement with Aesculap AG to distribute its vertebral compression fracture (VCF) treatment devices, including its new CE-Mark approved device – Osseoflex SB (steerable balloon) in select regions of Europe and Asia.

From B. Braun Melsungen AG 27 Feb 2012

ATI commences European trial of neurostimulation system for migraine

Autonomic Technologies, Inc. (ATI), the developer of a novel miniaturized implantable stimulator for severe headaches, today announced initiation of a study in Europe to evaluate the safety and efficacy of the company's investigational neurostimulation system for the treatment of high frequency, high disability migraine.

27 Feb 2012

KIT, FZI to present innovations for everyday life in the future at CeBIT fair

At the CeBIT in Hanover, Karlsruhe Institute of Technology and the FZI Research Center for Information Technology will present innovations for our everyday life in the future.

27 Feb 2012

New process can create LEDs that produce light in the UV range

A multinational team of scientists has developed a process for creating glass-based, inorganic light-emitting diodes (LEDs) that produce light in the ultraviolet range. The work, reported this week in the online Nature Communications, is a step toward biomedical devices with active components made from nanostructured systems.

27 Feb 2012

CT scan as effective as MRI in predicting recurrent stroke risk

New research from the University of Calgary's Hotchkiss Brain Institute (HBI) shows that using a CT (computerised tomography) scan, doctors can predict if patients who have had a transient ischemic attack (TIA) or minor stroke, with neurological symptoms such as weakness or speech issues, are at risk for another more severe stroke.

27 Feb 2012

Lung function, obstructive airway diseases linked with increased risk of heart failure

A large population-based study has found that lung function and obstructive airway diseases are strongly and independently associated with increased risk of heart failure. Importantly, say the investigators, this association was even evident in never-smokers and was still evident after adjustment for smoking status and number of years smoking. This, they add, indicates "that our results are not primarily confounded by smoking".

26 Feb 2012

Medicare's fraud-busting computer has slow start

The Associated Press/Washington Post: Inside Washington: Slow Start For Medicare's New Fraud-Busting Computer Disappoints Lawmakers Launched last summer, a $77 million computer system to stop Medicare fraud before it happens had prevented just one suspicious payment by Christmas.

24 Feb 2012

More smokers choose vaping over smoking

Many people like the idea of smoking a lot more than they like the reality, and more of them are choosing vaping over smoking every day. Vaping? Well, electronic cigarettes use vapor not smoke, so users don't smoke them.

24 Feb 2012

SANUWAVE, CAN-med Healthcare enter distribution agreement for dermaPACE device

SANUWAVE Health, Inc. has entered into a two-year exclusive distribution agreement with CAN-med Healthcare, a division of IMP Group Limited, to distribute the Company's dermaPACE device throughout Canada.

24 Feb 2012

MRI on the nanoscale closer to realty

Magnetic resonance imaging (MRI) on the nanoscale and the ever-elusive quantum computer are among the advancements edging closer toward the realm of possibility, and a new study co-authored by a UC Santa Barbara researcher may give both an extra nudge. The findings appear today in Science Express, an online version of the journal Science.

24 Feb 2012

Blue Belt's Navio PFS System receives CE Mark approval

Blue Belt Technologies, Inc., a medical device company focused on developing the next generation of "smart" surgical instruments providing precise robotic control for use initially in orthopedic procedures and then for other surgical specialties including neurosurgery, spinal and otolaryngology, announced today that it has received CE Mark for the Navio™ PFS System.

24 Feb 2012

Biofund, Quintiles to expand clinical development services in Russia

Russian Venture Company Biofund, a Russian-based investment firm, and Quintiles, the world's leading biopharmaceutical services company, today announced a definitive agreement to support expansion of clinical development services within the Russian Federation, the world's ninth most populous country.

24 Feb 2012

FDA clears invendo medical's new C20 colonoscopy system

invendo medical announced today that the company received 510(k) clearance by the U.S. Food and Drug Administration of the company's new C20 colonoscopy system including the SC20 single-use colonoscope.

24 Feb 2012

Federal rules for HIT 'meaningful use' expected today

Federal health IT officials said Wednesday that the proposed rules for the second stage of the federal program to fund electronic health records will be released Thursday. Office of the National Coordinator Director Farzad Mostashari and other top officials made the announcement at the Healthcare Information and Management Systems Society conference in Las Vegas to two ballrooms packed full of people who had hoped to see the details earlier this week.

24 Feb 2012