Medical Devices Today

FDA Policy Change Would Make It Easier To Start Pivotal Trials

Article preview from "The Gray Sheet"- October 31, 2011

FDA is changing the way it vets clinical trial plans to allow firms to start pivotal trials earlier while still ensuring that the study data ultimately supports a pre-market application.

Medicare's ACO Final Rule Responds To Provider Concerns, But Leaves Device Industry Dissatisfied

Article preview from "The Gray Sheet"- October 24, 2011

Although CMS' newly finalized rule on accountable care organizations has allayed health care providers' fears of a program too burdensome to bother with, medical device manufacturers remain worried that ACOs will curb patient access to their products.

Start-Up News

Article preview from Medtech Insight - September 1, 2011

Noteworthy news from medtech start-ups. This month's we feature HeartFlow, which is adapting computer modeling to cardiology to produce a precise, predictive, noninvasive diagnostic that doubles as a treatment planning tool, and Respira Therapeutics, which is developing a non-chemical method for delivering drugs to the lungs.

Articulinx Inc.

Article preview from Start-Up - September 1, 2011

Osteoarthritis affects almost 21 million Americans aged 25 or older, and is most prevalent in the hand. The need for an alternative to long-term drug therapy for treating early stage hand OA is a vastly underserved market that Silicon Valley-based Articulinx Inc. hopes to address with its Intercarpometacarpal Cushion, a spacer device used to augment cartilage in the basal joint of the thumb.

Much Ado About Nothing? Weighing The Impact Of The Institute of Medicine's 510(k) Report

Article preview from IN VIVO - September 1, 2011

Industry and regulators eagerly awaited the Institute of Medicine's 510(k) report, anticipating it could have a major impact on reforming this regulatory path. The result, however, has been one nobody expected: device companies and the FDA united in support of the current program.

Obesity And Diabetes: Toward A Surgical Solution: An Interview With Francesco Rubino, MD

Article preview from Medtech Insight - September 1, 2011

A new position statement from the International Diabetes Federation that endorses bariatric surgery as a medically indicated therapeutic option for diabetes represents an important philosophical shift for this field, according to Franceshttp Rubino, MD, chief of gastrointestinal metabolic surgery at Weill Cornell Medical College.

Cartilage Repair: Opportunities In Motion-Preserving Orthopedics

Article preview from Start-Up - September 1, 2011

Start-ups and investors are looking to address the large and growing gap between palliative treatment and major joint surgery for patients with cartilage damage in the knee, toes and hands - although the FDA is putting up more roadblocks than ever before. In this issue we profile Articulinx, Carticept Medical and Orthox.

Lutonix: Back To The Future With Drug-Coated Balloons

Article preview from IN VIVO - September 1, 2011

Drug-coated balloons were once thought to be an unnecessary innovation because of drug-eluting stents. With DES no longer seen as the panacea for vascular disease, balloons could re-emerge as the next major technology platform, and Lutonix is leading the race to bring them to the US market.

Flurries Of New Bills Advance Device Industry Interests In Congress

Article preview from "The Gray Sheet"- October 17, 2011

The first legislative salvos were launched last week in a battle that is sure to escalate in conjunction with device user fee reauthorization efforts next year.

Urinary Incontinence: Mesh Slings Come Under Fire

Article preview from Medtech Insight - September 1, 2011

A large, undertreated patient population makes the urinary incontinence market an attractive arena for manufacturers; however, looming changes to the product approval process have added a level of uncertainty about future market growth.