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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
