Medical Devices Today

START-UP’s 2012 Life Science Venture Capital Survey: Optimism, Capital In Shorter Supply

Article preview from Start-Up - September, 2012

Our second annual survey of institutional and corporate VCs puts FDA, public markets, and limited partner support high atop a long list of concerns, although the attitude toward regulators is on the mend. A notable number of respondents also say they’ll have to accept lower terms and shrink ambitions as they raise new funds.

  

Wireless Revolution Attracts New Health Care Partners

Article preview from Medtech Insight - August, 2012
 

While device manufacturers look for ways to utilize wireless technology to enhance the use of their products, a number of nontraditional health care partners are emerging as important players in the market. Firms such as Qualcomm, AT&T, and other telecommunication companies are working to establish an infrastructure that will make it easier and safer for patient data to flow from remote devices to caregivers. These technology firms have already established deals and partnerships with some manufacturers, and although there is still a lot of work that needs to be done, their presence in this market is an important step that could hasten the ongoing wireless health care revolution.

 

Tight Glycemic Control: Critical Care’s Balancing Act

Article preview from IN VIVO - September, 2012 

Over a decade ago, the New England Journal of Medicine published a study identifying tight glycemic control in the intensive care unit as a critical step to improving outcomes. Today, GlySure and others are working on continuous glucose monitoring for the critical care environment to help deliver on that promise.

 

User Fee Limbo: FDA Will Not Have Access To Extra Industry Funds At FY 2013 Start

Article preview from "The Gray Sheet" - September 24, 2012

The new fiscal year starts Oct. 1, but FDA will not be able to spend the full amount of fiscal year 2013 industry user fees as a result of an emergency spending bill, and Congress is not expected to fix the issue until after the election in November at the earliest.

Device VCs Choose Flight, And Fight, In Face Of Challenges

Article preview from Start-Up - August, 2012

The entire venture capital industry is facing difficult times. But few are taking as hard a hit as medical device investors. In our survey of 100 institutional and corporate VCs, 65% of the venture capitalists who said they invest primarily in medical device companies say they’re feeling “negative” about “the current state and future of VC.” Only 17% say they feel positive, with the remainder feeling neutral. Not surprising, device VCs’ worries center around limited partners and the FDA. Limited partners are demanding strong returns before re-upping with new funds, and the FDA, while improving, is holding a firm line in issuing new approvals. Device VCs keep looking for innovative technologies and waiting for opportunities to improve.

Capsule Endoscopy: Poised For Growth

Article preview from Medtech Insight - August, 2012

The market for capsule endoscopy is one of the fastest growing segments in the multibillion-dollar gastrointestinal endoscopy market. The market opportunity is vast and highly underpenetrated, and an increasing number of competitors, new product innovations, and expanding indications for the technology are positioning capsule endoscopy as a market poised for growth – particularly if the technology is proven and FDA cleared for colon cancer indications.

Edwards’ High Wire Act In TAVI: An Interview With Mike Mussallem

Article preview from IN VIVO - September, 2012 

Given the competing interests and different challenges – balancing internal R&D with external M&A, managing rival customer groups, and tackling a tough regulatory path to name just three – Edwards Lifesciences’ success in TAVI may be even more impressive than it looks. IN VIVO interviews CEO Mike Mussallem about how Edwards developed TAVI and the obstacles and challenges the company faced along the way.

CDRH Accelerates Software Development To Improve Collaboration With Industry

Article preview from "The Gray Sheet" - September 17, 2012

FDA’s device center hopes the effort, which is intended to model a quicker-turnaround “Silicon Valley” approach to system development, will help reduce time-to-market for new devices, and simplify some post-market surveillance efforts.

Wireless Revolution Attracts New Health Care Partners

Article preview from Medtech Insight - August, 2012

While device manufacturers look for ways to utilize wireless technology to enhance the use of their products, a number of nontraditional health care partners are emerging as important players in the market. Firms such as Qualcomm, AT&T, and other telecommunication companies are working to establish an infrastructure that will make it easier and safer for patient data to flow from remote devices to caregivers. These technology firms have already established deals and partnerships with some manufacturers, and although there is still a lot of work that needs to be done, their presence in this market is an important step that could hasten the ongoing wireless health care revolution.

FDA Unveils Plan To Strengthen Device Post-Market Surveillance

Article preview from "The Gray Sheet"-  September 10, 2012

Combining new techniques with improvements to current tools, the strategy aims for "near real-time" post-market surveillance.