Abiomed's blood pump system lands FDA nod | Series C round pulls in $19M for OrthoSensor | Simplify Medical acquired by Australian private-equity shop
March 24, 2015
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Abiomed's blood pump system lands FDA nod
The FDA has granted Abiomed approval to market its Impella 2.5 System, a miniature blood pump that preserves heart circulation and function during stenting and angioplasty. According to Abiomed, the Impella 2.5 is the first device approved to provide hemodynamic support during risky PCI procedures. Forbes (3/24), Reuters (3/23)
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Business & Market Trends
Series C round pulls in $19M for OrthoSensor
OrthoSensor has obtained $19 million in a Series C financing round of preferred stock. The company will use the money to commercialize its Verasense technology, a total knee replacement instrument assisted by a disposable sensor. BeckersSpine.com (3/23)
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Simplify Medical acquired by Australian private-equity shop
M.H. Carnegie, an Australian private-equity shop, has purchased Mountain View, Calif.-based Simplify Medical for undisclosed terms. Simplify is preparing for a U.S. study of its Simplify Disc, an MRI-friendly artificial cervical disc. MassDevice.com (Boston) (3/23)
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Former Qiagen Marseille managers set up new cancer Dx firm
The former executive management team of Qiagen Marseille has established HalioDx, an immuno-oncology diagnostics company, following a buyout. Vincent Fert will serve as CEO of HalioDx, and the managers and 75 employees of Qiagen Marseille have moved to the new company. HalioDx will focus on developing assays for forecasting the response of patients to immuno-oncology treatments for solid tumors. GenomeWeb Daily News (free registration) (3/23)
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Benvenue Medical announces new CFO
John Dahldorf has been appointed chief financial officer of Benvenue Medical, a maker of minimally invasive devices for repairing the spine. Dahldorf comes to Benvenue from Volcano, where he served as CFO. Healthcare Finance News (3/23)
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Diabetes technology improves, but patients still need support
Diabetes self-care has benefited from technologies such as the continuous glucose monitor, lancet-based glucose meters that store and share data and updated insulin pumps, David Yeager writes. Mobile applications for sharing and analyzing data also are popular, but registered dietitian nutritionist Susan Weiner says the emphasis on data can make people feel too much like a bunch of numbers, so they often turn to online diabetes groups for emotional support and information sharing. Today's Dietitian (3/2015)
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Emerging Technologies
Cryoablation device from AtriCure being promoted for new indication
CryoIce, a cryoablation device from AtriCure, is being promoted for temporary relief of pain in cardiac and thoracic surgery patients. The Ohio company said the device uses cryoanalgesia to stop pain impulses from reaching the brain, and in its new indication, the device ablates the intercostal nerve bundles to relieve thoracotomy incision-related pain. MassDevice.com (Boston) (3/23)
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AdvaMed commends budget proposal that includes medical device tax repeal
A congressional budget resolution that includes language to repeal the 2.3% excise tax on medical devices was praised by AdvaMed. The group called the tax a "drag" on innovative medtech firms. "Every cent paid toward this onerous tax is one that would be better spent on research and development, hiring and capital expansion," said JC Scott, AdvaMed's senior executive vice president. FDAnews (3/23)
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  • For more:
    Read the entire statement from AdvaMed Senior Executive Vice President JC Scott about the possible repeal of the medical device tax.
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Canada OKs next-generation sequencing system from Illumina
A medical device license was granted by Health Canada to Illumina's MiSeqDx tool, a next-generation sequencing system, together with its MiSeqDX Cystic Fibrosis Clinical Sequencing Assay and MiSeqDx Cystic Fibrosis 139-Variant Assay. The company said the next-generation sequencing system is the first of its kind to be approved in Canada. GenomeWeb Daily News (free registration) (3/23)
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EU approves Oncomine fusion panel from Thermo Fisher
European regulators have granted Thermo Fisher Scientific the CE-IVD mark for its Oncomine Solid Tumor Fusion Transcript, a next-generation sequencing-based kit that detects alterations involving the NTRK1, RET, ROS-1 and ALK genes. The fusion panel, which needs no more than 10 ng of RNA and makes use of the Ion AmpliSeq system, is validated for lung cancer. GenomeWeb Daily News (free registration) (3/23)
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AdvaMed News
Short Course on Adaptive Design
April 28
Westin Crystal City, Arlington, Va.

Preceding our 8th Annual Statistical Issues Workshop, the American Statistical Association is co-sponsoring a short course on Adaptive Design. The course will be taught by Dr. Christopher Coffey, University of Iowa. Learn more.
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8th Annual FDA/MTLI Medical Device and IVD Statistical Issues Workshop
April 29-30
Westin Crystal City, Arlington, Va.
This annual workshop, co-sponsored by the FDA and AdvaMed, brings together leading authorities from the FDA, industry and academia to address statistical topics in both therapeutic device and diagnostics tracks. Topics in the past have included missing data in studies of medical devices and diagnostics, adaptive designs in device trials, design and analysis of clinical trials with recurrent event endpoints, limit of detection methodologies, traceability and uncertainty of measurement, novel clinical trial design, clustered data and more. Learn more.
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