Article preview reprinted from Medtech Insight - June 2009
A number of industry experts have long believed that any significant change in health care must be tied to reimbursement, and the Centers for Medicare and Medicaid Services (CMS) has begun a pilot project that will test that theory. Under a three-year plan called the Acute Care Episode (ACE) demonstration, five sites in the US have been selected to use a single, bundled-payment system for hospital and physicians services associated with 28 cardiac and nine orthopedic inpatient surgical services and procedures. Read on...
Continue reading "Health Care Trends: Payment Bundling--The Future of Reimbursement?" »
Article perview reprinted from IN VIVO - June 2009
Sometimes just getting FDA approval isn't enough. AccessClosure got FDA clearance of its PMA vascular closure device, only to delay the product's launch in order to develop an improved version. The company forestalled one-and-a-half years of revenue to address physicians' concerns and introduce an improved product. This was particularly wise in the field of vascular access closure devices, where previous devices have disappointed. The decision appears to be paying off as the company is seeing rapid adoption even though its product is priced at a premium. Read more...
Continue reading "AccessClosure: FDA Clearance--Yes; Product Launch--Not Yet" »
Full article reprinted from 'The Gray Sheet" - July 20, 2009
Given Imaging expects its PillCam COLON 2 endoscopy capsule will overcome many of the limitations identified in a recent clinical trial comparing its first-generation PillCam COLON to standard colonoscopy. Find out more...
Continue reading "Given To Launch Next-Gen Colonoscopy PillCam In Europe In November" »
Full article reprinted from 'The Gray Sheet" - July 20, 2009
Medtronic, Boston Scientific, St. Jude Medical and AtriCure are targeted in an ongoing Justice Department probe into alleged off-label promotion of cardiac ablation devices for atrial fibrillation. Find out more...
Continue reading "DoJ Targets Five Cardiac Ablation Device Makers In False Claims Probe " »
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Full article reprinted from 'The Gray Sheet" - July 20, 2009
Medical device manufacturers are trying to prevent the creation of a National Medical Device Registry as proposed in a health care reform bill introduced in the House July 14. Find out more...
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Continue reading "House Health Reform Bill Calls For Sweeping National Device Registry" »
Deal summary reprinted from Strategic Transactions - July 2009
Edwards Lifesciences has agreed to sell its hemofiltration product line (also called continuous renal replacement therapy (CRRT)) from its Critical Care unit to Baxter International, its long-term supplier. Find out more...
Continue reading "Baxter Buys Edwards' CRRT Product Line" »
Fred Khosravi & Amar Sawhney: Dynamic Device Development Duo
Article perview reprinted from IN VIVO - June 2009
Located on opposite coasts and with complementary skill sets, Fred Khosravi, founder of EndoTex, teamed up with Amar Sawhney, founder of Confluent Surgical, to form Incept, which has become a powerful device company creation engine. Using a unique formula that launches new companies building on previous successes, Incept has compiled an enviable record, starting nine companies in 11 years with three exits and no failures. Read more...
Continue reading "Meet Medical Device Development's Dynamic Duo" »
Article preview reprinted from Start Up - June 2009
Today, mitral valve repair and replacement procedures involve opening the chest and stopping the heart. Hence, many patients who might otherwise benefit from therapy are excluded because they are either too ill or not ill enough to justify the risk. A percutaneous mitral valve replacement system in development from CardiAQ Valve Technologies intends to significantly reduce that risk by using a catheter to deliver a new mitral valve.
Continue reading "CardiAQ Valve Technologies" »