Medical Devices Today

Fractional Flow Reserve Makes Inroads In Interventional Cardiology

Article preview from Medtech Insight - January , 2012

Fractional flow reserve (FFR), a measurement of the severity of a coronary artery obstruction, has not yet reached mainstream use in the US, but that could soon change as interventional cardiologists face increased scrutiny about the “appropriateness” of their clinical treatment decisions. Part of that scrutiny will be driven by recent overstenting scandals, but cost-control measures are playing just much of a role in this shift. At the same time, ongoing advancements in FFR technology are helping to overcome barriers to use and could convince more physicians and hospitals to jump on the FFR bandwagon.

A-List Investor Spotlight

Article preview from Start-Up - January, 2012

Investors like Imperial Innovations and Jumpstart are stepping up to fill the gap in Series A investing.

Bioventus Spin-out Creates New Leader In Orthobiologics

Article preview from IN VIVO - January, 2012

The spin-out of Smith & Nephew’s Biologics and Clinical Therapies division into a privately held entity, Bioventus LLC may serve as a model for other large publicly held device companies seeking to maximize the performance of non-core businesses.

CDRH Drops Seven Divisive 510(k) Proposals; Congress Picks Some Up

Article preview from "The Gray Sheet"-  February 27, 2012

The device center is dropping seven controversial 510(k) reform-related proposals, including creating a “class IIb” category of devices, following pushback from industry. But some of the matters are under consideration on Capitol Hill.

Start-Ups Move Stem Cell Products Forward On Long Path To Market

Article preview from Medtech Insight - January , 2012

The dream of turning stem cell research into mainstream clinical therapies is making significant progress, as a large number of cell-based clinical studies are currently underway - some 2,700 stem cell clinical trials registered with www.clinicaltrials.gov between February 2000 and June 2010. While several companies have launched stem cell products onto the market, it’s the number of products in the pipeline that is starting to capture the attention of observers – including investors – who believe activity in current clinical trials is a telling sign of where the industry is headed.

Artificial Retinal Devices Help The Blind To See

Article preview from Start-Up - January, 2012

Worldwide rates of all diseases that cause blindness are expected to double by 2020 due to the aging population, making this an area ripe for medical device innovation. A multibillion-dollar market has been built around the surgical correction of "front of the eye" age-related vision disorders such as presbyopia, but the technological evolution in ophthalmology has now reached the back of the eye. Artificial retinal prostheses are an increasingly popular area of investigation. Start-ups hoping to enter this market face daunting R&D, clinical and regulatory hurdles, and will require significant resources. We profile three such companies in this issue: 2C Tech Corp., LambdaVision and Nano Retina.

Reverse Innovation: Is The US Losing Its Edge In Innovation?

Article preview from IN VIVO - January, 2012

Is US-style innovation in the medical device industry heading towards extinction? Gone are the days when companies believed they could build robust businesses by serving largely, if not exclusively, the US market. Today, emerging markets have become growth markets. But those markets, and even a post-health care reform US, challenge an innovation model that used to reward even incremental technology enhancements with premium pricing, by a price-insensitive customer.

 

Cook Medical Makes Its Case For Medicare New-Tech Add-On Payments

Article preview from "The Gray Sheet"-  February 20, 2012

 Cook is seeking add-on payments for its Zilver PTX drug-eluting peripheral stent and Zenith AAA endovascular graft in 2013, addressing related CMS questions at a Feb. 14 new-technology “town hall” meeting.

New Horizons In Medical Imaging: An Interview With Siemens’ Gregory Sorensen

Article preview from Medtech Insight - January , 2012

Marketplace uncertainty and pressures to reduce costs have had a major impact on the market for medical imaging technologies. Medtech Insight interviews Gregory Sorensen, MD, Siemens Healthcare’s CEO for North America about what’s on the horizon for the industry.

Alternative Financing Strategies For Medtech Start-Ups

Article preview from Start-Up - January, 2012

Pools of venture capital for life science companies are drying up. The good news is that there are alternative sources for young medtech companies. EBI convened a panel of experts at its recent IN3 conference to explain when and where to find them and presents here a Q&A with an angel investor, a representative from a venture debt firm, and an expert in non-dilutive grant funding.