Medical Devices Today

Cardiac Rhythm Management Market Faces Continued Challenges Ahead

Article preview from Medtech Insight - August 1, 2011

The CRM market is facing continued growth challenges as manufacturers struggle to jumpstart lagging sales and broaden adoption of implantable cardioverter defibrillators and cardiac resynchronization therapy devices while facing a brewing storm in the US over appropriate device use.

Jan Medical Inc.

Article preview from Start-Up - July 1, 2011

Just as nuclear submarines employ pressure waves to track objects in the sea, the Nautilus NeuroWave from Jan Medical Inc. uses the same technology to detect expansions and contractions of the skull caused by an increase or decrease in the amount of blood in the vascular system within the skull. These pressure waves will be used to quickly determine the type, location and size of stroke that a patient is experiencing.

Biologics: The Growth Engine In Advanced Wound Care

Article preview from IN VIVO - July 1, 2011

With estimated revenues in excess of $5 billion per year worldwide, the advanced wound care market has garnered the attention of both major companies and investors for its tremendous potential. Growth in this market is being driven by the development of new bioactive products that can successfully heal chronic wounds such as diabetic foot ulcers, which are among the most challenging and costly to treat.

Will Class IIb See The Light Of Day? FDA Sends Mixed Messages

Article preview from "The Gray Sheet"- September 26, 2011

It remains unclear how FDA will move forward with its most controversial 510(k) reform proposals, such as creating a separate class IIb category for more complex devices, with mixed messages from the agency on whether the proposals are still on the table.

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.