Report: Top medtech firms transitioning to service offerings | B. Braun completes integration of pump with Epic's EMR system | AngioDynamics seeks more workers for N.Y. manufacturing line
August 18, 2016
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Report: Top medtech firms transitioning to service offerings
A PwC Health Research Institute report shows leading medtech companies, including Medtronic, Stryker and Zimmer Biomet, are shifting toward providing hospital customers with services such as training and education, tailored solutions independent of their medical devices and services-based offerings. The report advised firms exploring the "New Health Economy" to assess if they can best provide patient-focused products or service solutions, prepare for engaging in risk sharing or value-based contracts, develop devices for generating data and consider collaborations with other shareholders.
Medical Device & Diagnostic Industry online (8/17), (8/17) 
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What is the FDA inspector looking for?
FDA inspections can be a significant source of anxiety for drug and device makers. In order to alleviate some of that anxiety, firms need to know what the FDA is looking for during inspections so they can better prepare for them and, thus, increase the likelihood of a positive outcome. This prerecorded webinar can benefit you. Read More.
Business & Market Trends
B. Braun completes integration of pump with Epic's EMR system
B. Braun Medical's Infusomat Space Pump has been integrated with Epic's EMR system using IHE standard communication protocols and transactions. B. Braun Medical said the functionality of its AutoComplete feature has been verified and tested in cooperation with Epic.
Medical Design & Outsourcing (8/17) 
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AngioDynamics seeks more workers for N.Y. manufacturing line
AngioDynamics is looking to hire 25 more workers for its angiographic catheter manufacturing line at its Queensbury, N.Y., site to meet growing demand after Cook Medical recalled several of its angiographic products. The company, which has already recruited 50 workers and added a second shift on the production line, has doubled output at the location during the past three months.
The Business Journals (tiered subscription model)/Albany, N.Y. (8/17) 
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Trovagene liquid biopsy tests gain insurance coverage
Blue Cross Blue Shield of Illinois has agreed to cover the use of Trovagene's full line of Trovera liquid biopsy tests. The decision applies to 8 million members of the state plan.
GenomeWeb Daily News (free registration) (8/17) 
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New president, CEO named by Alphaeon
Murthy Simhambhatla, former president of Abbott Medical Optics, has been tapped to serve as president and CEO of Alphaeon. Simhambhatla replaces Robert Grant.
Orange County Business Journal (Irvine, Calif.) (8/17) 
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New CFO named by Valeritas
Erick Lucera, who has more than 20 years of experience in medtech, biotech and specialty pharmaceutical investment and operations, has been tapped to serve as chief financial officer at New Jersey-based commercial-stage medtech company Valeritas. Lucera served most recently as chief financial officer at late-stage oncology firm Viventia Bio.
Worcester Business Journal (Mass.) (8/17) 
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Science & Health
Trial of InVivo's neuro-spinal scaffold yields improvement in another patient
Another patient in a trial of InVivo Therapeutics' neuro-spinal scaffold has demonstrated signs of improvement using the American Spinal Injury Association's scoring system, going from a complete to an incomplete spinal cord injury within three months after implantation. The trial has shown AIS grade improvement in five of eight patients so far. (Boston) (8/17) 
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Emerging Technologies
Barrier membrane for oral surgery debuted by Citagenix
The Neomem FlexPlus, a single-layer collagen membrane, has been launched by Antibe Therapeutics' subsidiary Citagenix. The high-performance barrier membrane, made from porcine peritoneum, is designed for use in regenerative procedures during oral surgery.
FDAnews (8/17) 
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Government & Regulatory
Senate bill would strengthen safeguards for contact lens sales
Sens. Bill Cassidy, R-La., and John Boozman, R-Ark., have introduced the Contact Lens Consumer Health Protection Act to federally enforce prescription verification safeguards that promote contact lens patient health and to hold contact lens sellers accountable for sales tactics that may be putting patients at risk. AdvaMed is among the organizations supporting the bill, which would require retailers to dispense contact lenses exactly as prescribed, communicate with prescribers when issues arise, establish a patient safety hotline and use a live person instead of an automated system to verify prescription information, among other provisions.
Morning Consult (8/18) 
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FDA: Custom Ultrasonics' reprocessors still not to be used for duodenoscopes
The use of Custom Ultrasonics' System 83 Plus automated endoscope reprocessors in cleaning duodenoscopes is still not advised by the FDA after finding in November that the reprocessors lack validation. However, the agency says the device can now be used in cleaning other types of flexible endoscopes.
Regulatory Focus (8/17) 
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AdvaMed Events and Education
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. 30 | San Jose, Calif.
Join us as WEN partners with Women in Technology International for a unique half-day event, focused on driving innovation in leadership within your organization and the importance of "intrapreneurship." WEN and WITI will hold an afternoon session around the topic of innovation in leadership followed by an evening networking reception and panel discussion on how digitization is changing health care technology. Learn more.
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10th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
April 25-26, 2017 | Washington, D.C.
This annual conference brings together leading authorities from the FDA, industry and academia to address statistical topics through two tracks: therapeutic device and diagnostics. More details to be announced in the fall of 2016.
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I have learned over the years that when one's mind is made up, this diminishes fear.
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