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Medtech Insight- April, 2010
The global market for orthobiologics, comprised primarily of bone replacement materials, reached almost $2 billion in 2009 and is growing at an overall rate of 7%. Medtronic leads in bone replacement with a 45% market share, but overall growth in orthobiologics may come from emerging segments, particular synthetic and stem-cell based technologies.
Continue reading "Bioactive Technologies for Bone Replacement" »
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Start Up - May, 2010
In March 2010, Elsevier Business Intelligence convened a panel of venture capitalists and CEOs of devicestart-ups to discuss the climate for early and late stage funding. Their conclusion: there is money out there, if companies do the right things.
Continue reading "Medtech Venture Investing 2010: Do the Right Thing " »
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IN VIVO- May, 2010
Device companies large and small have failed repeatedly in efforts to address bifurcations, which remain one of the largest unmet opportunities in cardiology. Cappella thinks it can solve the problem with a device that's a new version of an old idea, reversing current protocol to treat the side branch first.
Continue reading "Cappella: Can a New Twist On An Old Idea Solve the Bifurcation Challenge?" »
Article preview from "The Silver Sheet"- May 24, 2010
A recent spike in Class I medical device recalls has led FDA to question whether manufacturers are sacrificing quality to rush products to market.
"We're concerned because we have seen a substantial increase in the number of recalls over the last few years," Steve Silverman, senior advisor to the CDRH director, said May 5 at the MedCon medical device conference in Cincinnati.
Continue reading "FDA Worried That Class I Recall Jump Reflects Industry Rush To Market " »
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"The Gray Sheet"- May 24, 2010
A recent spike in Class I medical device recalls has led FDA to question whether manufacturers are sacrificing quality to rush products to market.
Continue reading "FDA Worried That Class I Recall Jump Reflects Industry Rush To Market " »
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"The Gray Sheet"- May 24, 2010
FDA may publicly disclose more information on specific devices prior to marketing approval under a May 19 proposal to increase transparency.
Continue reading "FDA Unveils 21 Policy Changes To Increase Transparency With Public " »
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IN VIVO- April, 2010
Building off conventional ultrasound technology, France's SSI hopes to
change the way breast cancer detection is done, reducing the number of
unnecessary biopsies by employing elastography to register the
stiffness of breast tissue. But as the company seeks to challenge a
3000 year old, low tech approach--manual palpation--company officials
are proceeding slowly and are cautious about the claims they make for
their technology's innovativeness.
Continue reading "SSI: Revolutionizing Breast Cancer Detection, but Slowly" »
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Start Up - April, 2010
Companies developing devices for diabetes have to ask a question that
companies in other medical device fields don't: what about the users,
the people with diabetes? How will they use the device?
Continue reading "Insulin Device Companies' New Mantra: Real Simple " »
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Medtech Insight- April, 2010
Medtech Insight interviews Adnan Siddiqui, MD, PhD, assistant professor
of neurosurgery and radiology at the State University of New York,
Buffalo, a pioneer in the use of interventional technology for acute
ischemic stroke. Siddiqui offers his perspective on the current state
of endovascular devices for AIS, the unique challenges faced by
physicians in this field, and the factors driving interest in
stent-based technologies.
Continue reading "Device-Based Stroke Intervention: An Interview with Adnan Siddiqui" »