Thermo Fisher reports record revenues in first quarter | 5 early-stage device firms in Mass. secure $2.3 million in loans | Aggredyne pulls in $3M in latest financing round
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April 26, 2012
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Boston Scientific lands FDA approval for iliac stent
The FDA has granted Boston Scientific premarket approval for its Epic stent, which comes on the heels of a successful clinical study conducted earlier this year. The self-expanding device is designed to treat lesions in the iliac arteries. MassDevice.com (Boston) (4/25)
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Free Webinar On Demand ? Supply Chain Risk Management ? The area of Supplier Management is under tight scrutiny by regulators globally. Learn to identify the pressing issues that make Supplier Management challenging within the Life Sciences industry, and discover how the application of sound risk management and the adoption of cross-industry best practices can help bring it under control. Request now.
 
Business & Market Trends
Thermo Fisher reports record revenues in first quarter
Thermo Fisher Scientific said its revenues rose to a record $3.1 billion during the first quarter, an increase from $2.72 billion during the same period last year. The Waltham, Mass-based maker of scientific instruments attributes the revenue growth to a rising demand for its products and services, specifically in China and other emerging markets. Mass High Tech (Boston) (4/25)
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5 early-stage device firms in Mass. secure $2.3 million in loans
The Massachusetts Life Sciences Center has awarded loans worth $2.3 million to five early-stage companies in the state. Among those receiving a loan are Alcyone Lifesciences, which is working on a novel micro-catheter to treat neurological diseases, and Strohl Medical Technologies, which is developing a device to triage patients at risk for stroke. Mass High Tech (Boston) (4/25)
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Aggredyne pulls in $3M in latest financing round
Aggredyne, a biomedical diagnostics firm involved in platelet function testing, raised $3 million in a Series A convertible preferred stock funding round. The Houston firm is preparing to apply for U.S. marketing approval for its laser-light scattering platelet aggregometer, AggreGuideTM A-100, and related blood platelet tests. American City Business Journals/Houston (4/23)
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International Developments
Boston Scientific's heart stent wins approval in Canada
Boston Scientific has received approval from Health Canada for its PROMUS Element Plus stent and plans to start marketing the device there immediately. The device, designed to treat patients with coronary artery disease, improves on the company's existing stent with a better-performing catheter delivery system. Reuters (4/25)
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Malaysia adopts laws to set up medical device approval system
The Malaysian government has approved a pair of laws to establish a formal medical device regulatory framework in that country. The Medical Device Authority Act of 2012, which establishes device registration and licensing standards, took effect on March 15. Meanwhile, the Medical Device Act of 2012, which sets up the agency that will regulate medical devices, is expected to take effect "later this year," but will not be fully enforced until 2014. MassDevice.com (Boston) (4/25)
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Science & Health
Device offers a way to manage chronic pain without medication
An implantable neurostimulator approved last year by the FDA could help bring relief to patients suffering from chronic pain without the need for drugs. The device, developed by Medtronic, works by transmitting electrical impulses to block pain signals from reaching the brain, allowing the patient to feel a vibration instead of pain. KHOU-TV (Houston) (4/24)
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Emerging Technologies
Toshiba's technology to reduce radiation dose gets FDA OK
The FDA has granted Toshiba America Medical Systems clearance to market its third-generation Adaptive Iterative Dose Reduction 3D software. The technology, which can cut radiation dose better than traditional scanning, is designed to work in both the image data and raw data space. HealthImaging.com (4/26)
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Business Tips and Advice
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Industry Service Providers
Siemens forges radiotherapy partnership with Varian
Siemens Healthcare has entered an agreement with Varian Medical Systems to jointly promote each other's products for cancer imaging and treatment in the global market. The deal also calls for the companies to create new products for image-guided radiotherapy and radiosurgery. AuntMinnie.com (free registration) (4/25)
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Government & Regulatory
Abbott gets expanded FDA clearance for cataract laser
Abbott has received FDA clearance for use of its iFS Advanced Femtosecond Laser in making arcuate incisions during cataract surgery and other corneal procedures. The device already has been approved for use in making a variety of other corneal incisions. "This is an important step as we look to utilize femtosecond laser technology as a potential standard of care during the cataract procedure," said Abbott Senior Vice President Jim Mazzo in a release. BeckersASC.com (4/23)
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AdvaMed News
Getting to Market in the EU: Making Sense of the Many EU Requirements for Clinical Data
Tuesday, May 08
Webinar, 12:00 p.m. - 1:00 p.m. EST
With the recent medical device scandals in the EU, the commissioner has publicly requested tighter controls. Clinical evaluations are an area that have come under scrutiny in recent years, resulting in multiple changes in the regulations and standards, and creating additional potential consequences for manufacturers who are selling legacy devices or planning to introduce new models in the EU. Device manufacturers need to know what the new requirements are and how they may affect existing and new product certifications. In this live webinar, participants will have the opportunity to hear from the expert presenter, Dr. Dannhorn, on strategies for meeting the new requirements and have the opportunity to ask questions. Visit MTLI online for more information.
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Medical Device Workshop on FDA Inspections, Warning Letters and CAPA
Tuesday, May 22 - Wednesday, May 23
Sheraton Crystal City, Crystal City, Va.

The percentage of CAPA system deficiencies in FDA warning letters has increased in the past five years. This conference will provide you with the tools to avoid warning letters, enable you to demonstrate your compliance initiatives and teach you how to respond to a warning letter. Learn how properly to integrate and implement your CAPA program to improve internal processes and products and better achieve business objectives. Network with a distinguished panel of experts for an in-depth examination of what CAPA is, how the concept has evolved and whether it accomplishes what industry needs and what FDA expects. Visit MTLI online for more information.
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Who's Hiring?
Position TitleCompany NameLocation
Principal Regulatory Affairs Specialist-Endo-Santa Rosa CAMedtronicSanta Rosa, CA
Regional Sales DirectorRegenesis Biomedical, Inc.Home based office, CA
Manager, Regulatory Affairs - 1 of 2Johnson & JohnsonFremont, CA
R&D Technical Project ManagerEndologix, Inc.Irvine, CA
Post Market Surveillance Regulatory SpecialistW.L. GorePhoenix, AZ
Regulatory Affairs ProfessionalW.L. GoreFlagstaff, AZ
Director Global Marketing -- Core Brand ManagementCovidienNew Haven, CT
Regulatory Affairs ProfessionalW.L. GoreFlagstaff, AZ
Regulatory Affairs ProfessionalW.L. GoreFlagstaff, AZ
Sr. Quality Engineer - New Product DevelopmentEndologix, Inc.Irvine, CA
Regulatory Affairs Professional ? Venous/AccessW.L. GoreFlagstaff, AZ
Senior Corporate CounselCovidienNew Haven, CT
Vice President ? Research, Payment and Health Care Delivery PolicyAdvaMedWashington, DC
Manager, Sales Strategy - Transcatheter Heart Valve - 001277Edwards LifesciencesIrvine, CA
Public Affairs CoordinatorAdvaMedWashington, DC
Regulatory Affairs, Project Manager - Cardiac Surgery Systems- 001280Edwards LifesciencesSalt Lake City, UT
Senior Analyst, CAD - 000614Edwards LifesciencesIrvine, CA
Senior Quality Manager -Transcatheter Heart Valve - 001190Edwards LifesciencesIrvine, CA
Director, MarketingEndologix, Inc.Irvine, CA
Regulatory Affairs Senior Associate -Transcatheter Heart Valve - 001264Edwards LifesciencesSalt Lake City, UT
Director, Clinical Data Management - Transcatheter Heart Valve - 000751Edwards LifesciencesIrvine, CA
Director, Biostatistics - Transcatheter Heart Valve - 001160Edwards LifesciencesIrvine, CA
Project Manager, Supplier Development - Transcatheter Heart Valve - 001303Edwards LifesciencesIrvine, CA
Senior Regulatory Affairs Manager with PMA ExperienceCochlear LimitedCentennial, CO
Regulatory Affairs Manager Johnson & Johnson Irwindale, CA
Senior Program Manager - Critical Care - 001311Edwards LifesciencesIrvine, CA
Click here to view more job listings.
 
SmartQuote
One person with a belief is equal to a force of 99 who have only interests."
-- John Stuart Mill,
British philosopher and political economist
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