Medical Devices Today

Cautious FDA Is Obstacle For Burgeoning Diabetes Device Market

Article preview from Medtech Insight - August 1, 2011

Is innovation in the diabetes device market being hampered by a slowdown in FDA approvals? That question was the unofficial, under-riding theme at the American Diabetes Association 71st Scientific Sessions in June.

Patient-Centric Devices Promise Cost-Efficient Advanced Wound Care

Article preview from Start-Up - July 1, 2011

The treatment of chronic wounds is challenging, not only because of the underlying biology, but also because of more practical considerations: fragmentation in the care settings, the logistics of delivering products to patients, and the costs of chronic care. Next generation advanced wound care companies are engineering solutions to these problems.

The Fogarty Institute For Innovation: A Device Incubator For Difficult Times

Article preview from IN VIVO - July 1, 2011

Go to any gathering of medical device start-up CEOs and their investors, and beneath a veneer of passionate intensity about individual technology lie concern, anxiety, and in some cases, real pessimism. Central to the debate: is the device innovation model broken? Six years ago, one of the most celebrated device entrepreneurs, Tom Fogarty, MD, working with officials at El Camino Hospital in Mountain View, CA, an independent community hospital located in the heart of the San Francisco device community, launched the Fogarty Institute for Innovation, an initiative designed to help the earliest-stage companies ramp up technology development quickly and efficiently in an effort to minimize, if not eliminate the external challenges.

FDA Outlines Path For Guidance On Clinical Decision Support Tools

Article preview from "The Gray Sheet"- September 19, 2011

CDRH officials are looking for ways to better define when and how clinical decision support tools included in mobile health applications or medical software should face FDA regulation.

US Pain Management Device Market: Catering To An Aging Population

Article preview from Medtech Insight - August 1, 2011

An aging population along with new standards of care for treating pain could signal strong growth ahead for medical device manufacturers targeting the multibillion dollar pain management market.

Some VC Funds Have Miles To Go While Others Have Burned What's In The Tank

Article preview from Start-Up - July 1, 2011

The slowdown and shake-out predicted to occur in the world of venture capital has come. But has it also already gone, too? The industry has certainly retrenched, but there are also signs of new life in the venture sector. For the past two years, we've tracked a few dozen life sciences firms, with an eye on which ones have nearly tapped out their older funds and which have fresh cash to invest in young start-ups.

Private Bid For KCI Signals Growth In Wound Care

Article preview from IN VIVO - July 1, 2011

Historically, wound care has been a nice tuck-in business for both large medical device and pharmaceutical companies. But that dynamic appears to be changing as advanced technologies are developed that make this sector more attractive as a growth business, evidenced by the large number of recent deals and consolidation going on in this market. The latest example of this trend is the proposed $6.3 billion deal to make publicly traded Kinetic Concepts a privately held company.

Patent Reform A Reality: Costs And Opportunities Ahead

Article preview from "The Gray Sheet"- September 12, 2011

Comprehensive patent reform, which finally passed Congress last week after six years of debate, is likely to add new costs and uncertainties for device companies, but also important new opportunities for the most proactive of firms, patent attorneys say.

HeartFlow: Disrupting The Diagnostic Paradigm In Cardiology

Article preview from IN VIVO - July 1, 2011

Most current cardiac diagnostic imaging tests are highly inexact, relying heavily on clinicians' observations. HeartFlow is adapting advanced computer modeling to cardiology to produce a precise, predictive, noninvasive diagnostic that doubles as a treatment planning tool. The test could eliminate unnecessary procedures for patients and save the system money, but is that what interventionalists want?

Obesity Devices And The FDA Review Process: An Interview With Lee Kaplan, MD

Article preview from Medtech Insight - August 1, 2011

Medtech Insight interviewes Lee Kaplan, MD, director of the Obesity, Metabolism and Nutrition Institute at Massachusetts General Hospital and co-director of an upcoming meeting delineating best practices for clinical trials in the field of bariatrics.