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)
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)
|5 tips for managing negative online comments|
The Internet gives your customers a voice online, but what can you do when that voice is yelling negative comments? With 5 tips, you can learn how to positively respond and help direct the conversation. Read the article and learn the 5 ways to respond positively.
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
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)
|How to Achieve IT Agility: A Survival Guide for IT Decision Makers|
When business teams add new apps and services to already-strained networks, IT departments are accountable for making everything work. Is your team ready for this challenge? Read this eGuide to learn how IT teams are automating their networks, why they're utilizing Ethernet fabrics and SDN, and what success looks like as they regain network control and business relevance.
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)
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
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.
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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