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November 19, 2012News for medical technology professionals

  Top Story 
  • Vitacon gains FDA clearance for ultrasound bladder scanner
    The FDA has cleared Vitacon to market its VitaScan LT USB Scanner, a device used to measure bladder dysfunction and provide an alternative to urethral catheters to gauge bladder volume. The Norwegian company has struck a deal with Salus Consilium to distribute the device in the U.S. (11/16) LinkedInFacebookTwitterEmail this Story
  Business & Market Trends 
  • Mass. endoscopy device maker boosts assets and revenue in Q3
    Solos Endoscopy increased its assets to $3.4 million during the third quarter and generated $264,186 in revenue from January to September of this year. The Boston company, which makes the MammoView line of breast endoscopy devices, said the global increase in chronically ill and aging populations led to a growing need for its endoscopic services. Mass High Tech (Boston) (11/15) LinkedInFacebookTwitterEmail this Story
  International Developments 
  • Report sheds light on global prospects for U.S. medtech exporters
    A Commercial Service report that examines the market opportunities for U.S. exporters of medical devices in 49 countries has ranked Mexico and Kenya as among the most favorable economies in terms of used equipment. The report also has cited India as a hotspot for the medical equipment sector. (11/15) LinkedInFacebookTwitterEmail this Story
  Science & Health 
  • Smartphone diagnostic for diabetes, cancer patients is in the offing
    QUICK is working on a smartphone-based diagnostic platform that uses saliva or urine to aid in disease monitoring. The mobile health startup intends to initially use the device for monitoring ketone levels in diabetes patients, with plans to develop the system for measuring chemotherapy levels in cancer patients, among other applications. (11/16) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  • IPhone-based body thermometer scores 510(k) clearance
    The FDA has given Raiing 510(k) clearance to market a reusable thermometer sensor worn under the armpit that can contain as much as 72 hours worth of body temperature readings. The Raiing Wireless Thermometer uses Bluetooth to send real-time temperature data continuously to the Vitals Monitor software, a companion application accessible via the iPhone. (11/16) LinkedInFacebookTwitterEmail this Story
  Hot Topics 

Top five news stories selected by AdvaMed SmartBrief readers in the past week.

  • Results based on number of times each story was clicked by readers.
  Industry Service Providers 
  • Hospital GPOs award supply contracts to 3 medtech firms
    Cook Medical has signed a deal with Novation to supply the hospital group purchasing organization with its biopsy needles, balloon stents and other devices starting in January. Meanwhile, Pedia Pals and Clinton Industries have each received a contract to supply Premier with pediatric specialty devices, effective Nov. 1. (Boston) (11/15) LinkedInFacebookTwitterEmail this Story
  Government & Regulatory 
  • FDA clears Quantel Medical's eye treatment device
    Quantel Medical has been cleared by the FDA to market the SupraScan 577 laser system. The device provides U.S. eye specialists with access to the most advanced solid-state yellow scanning laser to treat retinal conditions, the company said in a release. (11/16) LinkedInFacebookTwitterEmail this Story
AdvaMed News 
  • 510(k) Submissions Workshop
    Monday, Feb. 25 - Tuesday, Feb. 26
    Sheraton Crystal City, Arlington, Va.
    This interactive workshop, taught by industry experts and key personnel from the CDRH 510(k) staff, leads participants step by step through the regulatory guidelines, practical steps and strategic considerations for determining a product’s regulatory route to market, identifying a predicate device, planning and assembling a 510(k) submission, interacting with the FDA during the review process, and dealing with post-clearance issues. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
  • Investigational Device Exemption (IDE) Submissions Workshop
    Wednesday, Feb. 27
    Sheraton Crystal City, Arlington, Va.
    MTLI offers this one-day interactive workshop to lead attendees through the regulatory and practical guidelines governing when an IDE is required, how to compile an effective IDE application, the rules governing clinical studies and human subject protection, Institutional Review Boards, types of pre-IDE meetings and communications, early/expanded access, foreign studies and export, and reimbursement for investigational devices. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
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