tag:typepad.com,2003:weblog-537311 2012-02-08T15:16:59-05:00 The Latest News In Medical Devices and Diagnostics. From Elsevier Business Intelligence, Windhover Information and Medtech Insight - The ULTIMATE free weekly device e-newsletter. TypePad tag:typepad.com,2003:post-6a00d83452f00669e20168e6feb9e6970c 2012-02-08T15:16:59-05:00 2012-02-08T15:16:59-05:00

Since heart attacks most often damage the left ventricle, left ventricular assist devices (LVADs) have become the treatment of choice for end-stage heart failure (HF) patients in this country. But pure product prices for today’s LVADs, which had previously been relegated to use only in end-stage disease but now are moving towards the treatment of earlier-stage HF patients, run as high as $120,000 per unit.

Josh tag:typepad.com,2003:post-6a00d83452f00669e2016301073b23970d 2012-02-08T13:58:51-05:00 2012-02-08T13:59:59-05:00

Delphinus Medical Technologies Inc. is applying underwater sound wave technology to more accurately and safely detect breast cancer. The Michigan-based company, a spin-out of the Barbara Ann Karmanos Cancer Institute in Detroit, has developed a full-breast ultrasound tomography system that quickly and effectively differentiates benign from malignant breast masses without compression or radiation exposure.

Josh tag:typepad.com,2003:post-6a00d83452f00669e20168e6fdd1c9970c 2012-02-08T13:49:32-05:00 2012-02-08T13:49:32-05:00

Medical device companies raised a total of $906 million in Q3, while in vitro diagnostic/research developers took in $72 million. The top M&As in each segment were private buyouts of public companies: Kinetic Concepts for $6.3 billion and Immucor for $1.9 billion.

Josh tag:typepad.com,2003:post-6a00d83452f00669e2016300db901b970d 2012-02-06T13:53:32-05:00 2012-02-06T13:53:32-05:00

The tentative agreement of $595 million in user fees over five years is more than companies had wanted to spend. But industry negotiators insist it is a good deal, tied to performance goals and process improvements they say will ensure greater speed and predictability in reaching the U.S. market.

Josh tag:typepad.com,2003:post-6a00d83452f00669e20163008b7c7b970d 2012-02-01T16:30:35-05:00 2012-02-01T16:30:35-05:00

Awarepoint, a New Leaf Venture’s portfolio companies, has adapted mobile IT to create a real-time tracking and location system that can help hospitals save money by running more efficiently while also increasing revenue.

Josh tag:typepad.com,2003:post-6a00d83452f00669e20168e682401d970c 2012-02-01T16:16:40-05:00 2012-02-01T16:16:40-05:00

The convergence of expanded access, lower reimbursement rates, higher velocity of innovation, diminished pools of venture capital, the advent of personalized care and a growing demand for improved patient outcomes has created ripples that already are altering the economics and operating dynamics of health care. To survive the coming storm, biomedical companies must build new models of innovation that are anchored in consumer-centric disease solutions rather than the traditional R&D department approaches.

Josh tag:typepad.com,2003:post-6a00d83452f00669e20168e6822540970c 2012-02-01T16:02:23-05:00 2012-02-01T16:02:23-05:00

The once staid US cataract surgery market has evolved considerably over the past several years. A trio of conferences this fall provided updates on the latest developments.

Josh tag:typepad.com,2003:post-6a00d83452f00669e20168e65ed0e6970c 2012-01-30T14:27:45-05:00 2012-01-30T14:30:38-05:00

The device center plans to finalize all the 510(k) program guidances it issued last year, among a boatload of 2012 priorities. Many of this year's top goals spring from the 510(k) and “science in regulatory decision making” reform programs that commanded attention in 2011.

Josh tag:typepad.com,2003:post-6a00d83452f00669e20163001c2a51970d 2012-01-25T14:02:11-05:00 2012-01-25T14:02:11-05:00

The effectiveness of a product is only one aspect of how well a device will succeed in the aesthetics market. In the following interview, Steven H. Dayan, MD, a noted Chicago plastic surgeon, tells Medtech Insight that manufacturers seeking to enter this space need to spend time on market research and fully understand where their products will be used and who will use them.

Josh tag:typepad.com,2003:post-6a00d83452f00669e201676110f3d4970b 2012-01-25T13:46:57-05:00 2012-01-25T13:46:57-05:00

A long-time darling of venture capital, the gastrointestinal sector has yet to meet expectation of VCs who wagered on technologies to treat gastroesophageal reflux disease, Barrett’s esophagus and even obesity. But some notable acquisitions, including Covidien’s purchase of privately held Barrx, may present a ray of hope for investors in GI companies.

Josh