Article preview reprinted from Medtech Insight - July/August 2009
The US home health care market, valued at nearly $4.5 billion in 2009, is set to experience steady growth in the years ahead, driven by a burgeoning aging population, a critical need for cost-effective solutions for patients suffering from long-term chronic conditions, and the increasing use of technology to meet the needs of those receiving home-based medical care. According to Medtech Insight's recent report "US Markets for Home Health Care Products," sales revenues for the major home health care product segments are expected to reach $5.2 billion by 2012. Read more...
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Full article reprinted from Start Up - August/September 2009
It's the end of a dynasty in the traditional market for self blood glucose testing--the test strips and hand-held monitors that patients have been using as the mainstay of their diabetes management. The four major companies, once differentiated players in a high growth market, have cut R&D and marketing budgets in the face of increasing commoditization. But a new era in continuous glucose monitoring has begun, and that sector is poised to grow in coming years, according to "US Markets for Diabetes Management Products," a report published in May 2009 by the Medtech Insight division of Elsevier Business Intelligence. Read more...
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Deal summary reprinted from Strategic Transactions - August 2009
Regenerative medicine firm Kensey Nash will use its extracellular matrix (ECM) technology to develop and manufacture porcine dermis-derived tissue, which Synthes (orthopedic devices) will market and distribute for certain reconstructive surgery applications. Read more...
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Article preview reprinted from IN VIVO - August/September 2009
Medical device investors in recent years subscribed to a bigger-is-better philosophy when it came to investing. VCs were eager to pour more capital into start-ups of all stages, believing it was shrewder or simply necessary to carry companies further along in development. However, a review of data from several sources suggests that bigger bets may not have been better. Read more...
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The FDA is increasingly finding alarming problems with training at device facilities. During a recent inspection, agency investigators not only checked whether a company had a training program, but assessed its adequacy. Companies increasingly lack a written training program or the program really doesn’t cover the fundamentals. Sometimes the employee isn't trained on a timely basis, or has no training at all.
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Article preview reprinted from "The Gray Sheet" - September 14, 2009
San Diego development-stage firm Minnow Medical plans to submit a 510(k) application for its first product, an energy-based peripheral vascular system, late this year. Read more...
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Full article reprinted from "The Gray Sheet" - September 14, 2009
CDRH's associate director for regulations and policy Kate Cook is leaving the device center to join FDA's biologics center, the agency confirmed last week. Read more...
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Deal summary reprinted from Strategic Transactions - August 2009
ValenTx (minimally invasive treatments for morbid obesity) has closed a $20.3mm equity financing to 24 undisclosed investors. Earlier this year the company filed a patent for its endoscopic gastrointestinal bypass sleeve with an attachment cuff. Read more...
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Article preview reprinted from Start Up - August/September 2009
In the past, it has been challenging for developers of non-invasive glucose monitoring systems based on optical platforms to separate out the signal generated by glucose from a high level of background "noise." Freedom Meditech, which uses a beam of red light to detect the concentration of glucose in the eye, believes it overcomes this problem and expects to sell its devices directly to consumers and through traditional diabetes product distribution channels. The company is also in the final stages of development with an in-office diabetes screening system that employs similar technology to identify individuals who may have undiagnosed diabetes or pre-diabetes. Read more...
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