Nigel Syrotuck, Starfish Medical
MEDdesign

12 Ways Graphene Will Transform Medical Devices

By Nigel Syrotuck

Within the last year, graphene has been a hot topic in tech news. If you were to believe the articles, it can increase computing power, improve battery storage, replace batteries…

Within the last year, graphene has been a hot topic in tech news. If you were to believe the articles, it can increase computing power, improve battery storage, replace batteries…

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Achieving safety, quality and compliance in medical device software.

Medical Device Software Safety, Quality, and Compliance: What Really Makes A Difference?

By Carl Wyrwa

…problematic and time consuming especially if the component being developed is of medium to high complexity. Make key decisions before coding Making key design decisions prior to beginning the coding…

…problematic and time consuming especially if the component being developed is of medium to high complexity. Make key decisions before coding Making key design decisions prior to beginning the coding…

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Maria Fontanazza and Ian Strickland discuss future of medtech market at AdvaMed 2015

MedTech Market to Hit $470 Billion by 2020, Prepare for Consolidation

By MedTech Intelligence Staff

The medtech market is expected to experience slow growth over the next five years, according to the recently released report by market research firm Evaluate, “World Preview 2015, Outlook to…

The medtech market is expected to experience slow growth over the next five years, according to the recently released report by market research firm Evaluate, “World Preview 2015, Outlook to…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Drama Continues with Duodenoscopes

…820 Compliance. Charleston, SC: Amazon. FDA orders duodenoscope manufacturers to conduct postmarket surveillance studies in health care facilities. (October 2015). FDA News Release. Accessed October 12, 2015. Retrieved from http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm465639.htm…

…820 Compliance. Charleston, SC: Amazon. FDA orders duodenoscope manufacturers to conduct postmarket surveillance studies in health care facilities. (October 2015). FDA News Release. Accessed October 12, 2015. Retrieved from http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm465639.htm…

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John Babitt, Ernst & Young, Pulse of the Industry report at AdvaMed 2015

2015 MedTech Highlights: Low Industry Growth, VC Declines, M&A Impressive

By MedTech Intelligence Staff

…of strength include the IPO market, with 43 companies going public in the 12-month period that ended June 30, and 16 mergers and acquisitions deals in excess of $1 billion….

…of strength include the IPO market, with 43 companies going public in the 12-month period that ended June 30, and 16 mergers and acquisitions deals in excess of $1 billion….

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CDRH’s Shuren: Future is Bright, We Need to Take Risks

By Maria Fontanazza

…is about the recognition that when a company has a good technology, it wants to deliver it to patients as quickly as possible without compromising safety and effectiveness. “We’re focused…

…is about the recognition that when a company has a good technology, it wants to deliver it to patients as quickly as possible without compromising safety and effectiveness. “We’re focused…

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Munroe and Cohen, Reimbursement Report
Reimbursement Report

When Can I Appeal My Health Insurance Carrier’s Decision?

By Kristofer C. Munroe, Aaron Cohen

…restriction to care for patients based upon factors like geography more than medical necessity. Just as patients have a legitimate interest in receiving the best care, insurance companies have a…

…restriction to care for patients based upon factors like geography more than medical necessity. Just as patients have a legitimate interest in receiving the best care, insurance companies have a…

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Nicole Littman, Quorum Consulting
Soapbox

CMS Reveals Rationale for NTAP Decisions in Rule Making

By Nicole Littmann

…were a result of not meeting CMS’ newness criterion. Newness is defined as the first commercial distribution of the technology being sufficiently recent so that cost of the technology is…

…were a result of not meeting CMS’ newness criterion. Newness is defined as the first commercial distribution of the technology being sufficiently recent so that cost of the technology is…

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Pediatric technologies

MedTech Designers: Children Are Not Small Adults

By Maria Fontanazza

…said Carlson. Consider implanting a device in a newborn. The product might not behave in the same way in 10 years. A pacemaker, for example, does not grow with the…

…said Carlson. Consider implanting a device in a newborn. The product might not behave in the same way in 10 years. A pacemaker, for example, does not grow with the…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Gasoline in the Stockroom, Burning Down the House!

By Dr. Christopher Joseph Devine

compliance issue, the storage of a flammable liquid in the vicinity of finished goods (regardless of commodity) is a common sense issue, or should the doctor state the obvious and…

compliance issue, the storage of a flammable liquid in the vicinity of finished goods (regardless of commodity) is a common sense issue, or should the doctor state the obvious and…

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