CELLSEARCH

The CELLSEARCH Circulating Tumor Cell Test from Janssen Diagnostics was the first diagnostic test to catch and detect circulating tumor cells (CTCs). The technology is used in patients with metastatic breast, prostate, or colorectal cancer. The system's analysis of these CTCs—cells that have come off of solid cancer tumors and are circulating in the blood—is used alongside other clinical information to give patients and clinicians usable information about cancer prognosis.

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September 28th, 2016
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xTAG

The Luminex xTAG technology is a proprietary tagging platform used to develop nucleic acid assays. xTAG diagnostic assays run on Luminex equipment are low-cost, accurate, and allow multiplexing in a single reaction, according to the company.

There are now xTAG assays for cystic fibrosis, respiratory viruses, gastrointestinal pathogens, CYP2D6 polymorphisms, and CYP2C19 variants. 

In 2010, the...

September 28th, 2016
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SAPIEN

Edwards Lifesciences' SAPIEN transcatheter aortic valve was a first of its kind, offering patients with severe aortic stenosis the chance to receive a new aortic valve without open surgery. While the technology was initially only available to those patients who couldn't undergo an open procedure, the company's later generation SAPIEN valves have been made available to less-sick patients. 

In August 2016, FDA granted approval for the latest generation of SAPIEN, SAPIEN 3 (pictured above) to be used in intermediate-risk patients.

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September 28th, 2016
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MELODY Transcatheter Pulmonary Valve

As the first transcatheter heart valve to receive FDA approval, the MELODY transcatheter pulmonary valve therapy offers valve replacement without open surgery. FDA granted approval to the device in 2010 through its Humanitarian Device Exemption program; it has had CE Mark since 2006. Patients often suffer from congenital heart disease they have had since they were born, so minimally invasive options to treat lifelong pulmonary valve dysfunction are important.

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September 28th, 2016
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S-ICD System

Boston Scientific's S-ICD System offers many patients cardiac defibrillation without transvenous leads. Leads can come with complications, such as migration and perforation, and attempts to remove leads can be risky too. The S-ICD is implanted subcutaneously and does not contact the heart or veins.

In August 2016, FDA granted approval to the third-generation Emblem MRI S-ICD, an MR-conditional device.

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September 28th, 2016
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TREVO XP ProVue Retriever

Stryker's TREVO XP ProVue Retriever is a clot retriever for patients with ischemic stroke. Clinicians can view the retriever under fluoroscopic imaging while performing the clot retrieval. According to the company, this allows for enhanced delivery and placement. The retriever comes in a variety of sizes, including 3x20 mm, 4x20 mm, and 6x25 mm.

The ...

September 28th, 2016
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T2Candida Panel

The T2Candida Panel from Lexington, MA-based T2 Biosystems offers fast turnaround on sepsis diagnosis. Rapid treatment of sepsis is important to treatment success. According to the company, the panel, which has 96.4% sensitivity and 99.4% specificity, offers results in hours and doesn't require a blood culture. 

Prix Galien awarded the T2Candida Panel the "Best Medical Technology" award in 2015....

September 28th, 2016
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These seven medtech products have been nominated for the Prix Galien Foundation "Discovery of the Decade" awards. 

The Prix Galien Foundation has named 33 nominees for its "Discovery of the Decade" awards in three categories—Pharmaceutical, Biotech, and Medical Technology. Commercial success and name recognition won't sway the decision. According to the foundation...

September 28th, 2016
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Seven major private payers and health technology assessment groups have raised their hand to give interested medical device companies early feedback on clinical trial plans and potential evidence requirements.

Marie Thibault

In what is akin to an expansion of the Parallel Review program, CDRH has publicized the names of seven private payer and health technology assessment (HTA) organizations who have volunteered to help medical device companies gain more insight into clinical evidence needed for reimbursement coverage.

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September 28th, 2016
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Researchers describe the potential of a novel parametric design approach for developing new stent designs faster.

Sanjay Pushparajan, Jaryl Ng Chen Koon, and Dr. Nicolas Foin

Recent advancements in stent development, from drug eluting stents to bioresorbable stents, utilize new materials with distinct properties. With these new materials comes the need for new stent geometries for prototyping and production.

Before a physical stent prototype is created, stent designs are typically drawn and modelled on CAD software like SolidWorks or Rhinoceros3D by a CAD specialist or mechanical engineer. These 3-D models are then exported to and tested virtually with a finite element analysis (FEA) solver like Abaqus. The 3-D models are analysed for...

September 26th, 2016
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