Stryker completes CareFusion portfolio purchase, reports Q1 profit growth | Funding round could pull in $3M for Baltimore medical device maker | Cepheid taps Medline in US distribution deal
April 22, 2016
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Stryker completes CareFusion portfolio purchase, reports Q1 profit growth
CareFusion's vertebral compression fracture portfolio, which includes minimally invasive systems for vertebroplasty and vertebral augmentation procedures, has been acquired by Stryker from Becton Dickinson. Stryker also generated $402 million in profits during the quarter ending March 31. (Boston) (4/21) 
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Business & Market Trends
Funding round could pull in $3M for Baltimore medical device maker
A round of Series A financing has brought in $1.5 million, with a potential $1.5 million in additional funding, for Baltimore-based Clear Guide Medical. The proceeds will be used to expand sales and marketing of the company's Clear Guide Scenergy, an accessory for ultrasound machines that blends ultrasound and CT images to guide surgeons during minimally invasive procedures.
The Baltimore Sun (4/21),  American City Business Journals/Baltimore (4/21) 
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Cepheid taps Medline in US distribution deal
Medline has reached a deal to distribute the GeneXpert platform and 20 Xpert tests from Cepheid to non-acute care laboratories in the US. Distribution will initially focus on Cepheid's moderately complex tests and its CLIA-waived influenza and respiratory syncytial virus test.
GenomeWeb Daily News (free registration) (4/21) 
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Medtech says it has sold 10 robotic surgical systems in Q3
Ten ROSA robotic surgical systems from Medtech Innovative Surgical Technology have been sold in the US, China and France during the company's fiscal third quarter, bringing the number of units used worldwide to 69. The ROSA platform, which comes in two models, is intended for use in minimally invasive brain and spine surgeries. (Boston) (4/21) 
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Q1 sales rise for Danaher
Danaher generated $5.39 billion in sales during the three months ending April 1, up 15% from the same period a year earlier. President and CEO Thomas Joyce said the Life Sciences and Diagnostics segment saw a year-over-year increase of 2.5% in core revenues and 42% in reported revenues, mainly driven by the company's purchase of clinical microbiology business MicroScan and filtration and purification company Pall.
GenomeWeb Daily News (free registration) (4/21) 
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Science & Health
Trial shows positive results for SI-BONE's joint fusion implant
A 172-patient, 26-site study published in the International Journal of Spine Surgery showed positive results for SI-BONE's iFuse Implant System, intended for sacroiliac joint fusion procedures. At two years, the use of the device led to maintained improvements in sacroiliac joint pain, disability and quality of life. (4/21) 
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Emerging Technologies
Medtronic's ablation balloon catheter debuts in US
The Barrx 360 Express radiofrequency ablation balloon catheter has been released by Medtronic in the US. The device is intended for treating Barrett's esophagus through removal of diseased tissue and reduction of esophageal tissue injury.
FDAnews (4/22) 
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Government & Regulatory
3D breast biopsy system from Hologic cleared by FDA
The FDA has given Marlborough, Mass.-based Hologic 510(k) clearance for its Affirm, a table-based biopsy system for 3D breast imaging. The system, which is already available in Europe, allows 3D breast images to be taken when patients are lying down.
The Boston Globe (tiered subscription model) (4/21) 
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Cartiva's cartilage implant wins positive vote from FDA panel
Premarket approval has been recommended by the FDA's Orthopaedic and Rehabilitation Devices Panel for the Cartiva Synthetic Cartilage Implant, a device intended for treating degenerative or posttraumatic arthritis in the first metatarsophalangeal joint. The panel voted in favor of the safety and effectiveness of Cartiva's implant, and a majority said the benefits of the device outweigh the risks.
Medscape (free registration) (4/21) 
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Canada OKs stent graft from W.L. Gore
Health Canada has given W.L. Gore & Associates approval to market its Excluder iliac branch endoprosthesis. The device, intended for use with the company's Excluder AAA endoprosthesis, is indicated for endovascular treatment of patients with common iliac artery aneurysms or aortoiliac aneurysms. (Boston) (4/21) 
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Attend the Global MedTech Compliance Bootcamp
AdvaMed and MedTech Europe will be hosting a full-day Compliance Bootcamp exclusively for small- and medium-sized companies on May 24, in Dublin, Ireland. Held during the Global MedTech Compliance Conference, the AdvaMed/MedTech Europe Compliance Bootcamp will be aimed at educating top leaders and compliance teams from small and medium-sized companies on understanding, developing and promoting the importance of ethics and compliance in the global MedTech environment. Register here!
AdvaMed Events and Education
Compliance Executive Speaker Series
May 18 | Sunnyvale, Calif.
Participants will have the opportunity to dissect some of the most pressing legal and compliance challenges facing their collective organizations stemming from emerging regulatory requirements, increasing concerns surrounding legal and commercial vulnerabilities due to cybersecurity concerns, an evolving risk paradigm concerning arrangements with third parties in the US and abroad, and considerations to factor into trade secret protection in light of increasing employment mobility. Learn more.
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Reimbursement 101: A Primer on Medical Device Reimbursement
June 28-29 | San Francisco, Calif.
During this workshop, you will be provided with the road map and practical applications to successfully navigate the many potential reimbursement pitfalls. After an overview of current reimbursement issues, you'll hear from industry veterans and reimbursement professionals who will discuss case studies and real-life scenarios. Learn more.
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