Medical Devices Today

Industry In Focus: US Home Health Care Revenues Set to Exceed $5 Billion by 2012

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...

Opportunity for Start-Ups in Continuous Glucose Monitoring

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...

Synthes to market and sell Kensey Nash's biomaterials

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...

Have Device VCs Bet Too Big?

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...

Requirement for Training at Device Facilities: Are you FDA Compliant?

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.

Boston Scientific, Bladder Health Form Co-Marketing Agreement

• C.S. Bard Unit Buys Spire’s Hemodialysis Catheter Product Line
• St. Jude Gets EU Clearance For Tiny Parkinson’s Disease Device
• Abbott To Buy Evalve For $410 Million For Heart-Repair System
• Medtronic Issues Caution About Heart Device Battery Power
• Ev3, NeuroVasx Work On Device Technologies For Brain Aneurysms
• Medtronic Said In Australia To Use Doctor Grants To Push Devices
• Integra Buys Most Of Innovative For $9.3 Million In Bankruptcy
• Boston Scientific, Bladder Health Form Co-Marketing Agreement
• Medtronic-Backed Study Says Physician Training Could Sell Implant Use
• Medtronic, Boston Sci, St. Jude Defibrillators Said Less Useful For Women
• Abbott Cleared In China To Market Xience V Drug-Coated Stent
• Edwards Chief, Others Lead Device Industry Effort Against New Fees
• Medtronic Artificial Lung, Others Shown Effective In Criticial H1N1 Flu

Peripheral Vascular System Could Launch In 2010, Minnow Medical Says

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...

FDA Device Center Loses Another Top Staffer

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...

ValenTx brings in $20.3mm through sale of equity

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...

Freedom Meditech Inc.

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...