Medical Devices Today

Senate Approves Device Tax; Details Now Up To House-Senate Conferees

Breaking news story reprinted from "The Gray Sheet" - December 24, 2009

With the Senate passage of landmark health care reform legislation, it is all but inevitable that device companies will be facing a new government fee for the long term.

Covidien Named Best Stock Choice To Buy In 2010 By Major Analyst

· FDA Gives Affymetrix, TessArae Four-Month Approval For H1N1Diagnostic

· Clarient Swaps Stock To Buy Applied Genomics For Cancer Diagnostics

· SpineMatrix Names Device Industry Veteran As New CEO

· “Medtronic, Boston Sci, Device Industry Get Reprieve For New Taxes

· DePuy Acquires Finsbury Of U.K. For Estimated $96 Million

· GE’s British Unit Uses Libel Law To Quash Criticism Of Its Omniscan

· Medtronic Launches Spinal Device Once Locked In Patent Dispute

· Hologic Loses Patent Suit Against SenoRx Cancer Radiation Catheter

· J&J’s Ethicon Pays $785 Million To Acquire Acclarent

· Photocure Imaging Drug Narrowly Backed By FDA Advisers

Remote Patient Monitoring: Roadblocks to Full Adoption

Article preview reprinted from Medtech Insight - October/November 2009

Recent advances in patient monitoring technology present a number of opportunities for remote monitoring and self-monitoring of patients outside the clinical setting. While the data captured during real-life situations is of value, not every segment of the health care market is rushing to embrace the latest technology advances in this area, for a variety of reasons. In particular, the market for implantable cardiac rhythm devices sticks out as an area where many physicians (and manufacturers as well) are simply not sure how to utilize all the data that could be harvested via the latest remote monitoring technology. Read more...

Rumblings of Change in the Hearing Markets: Sonova Buys Advanced Bionics

Full article reprinted from Start Up - November/December 2009  

The hearing markets have followed a different evolutionary branch than the rest of the medical world, with a complicated infrastructure, and a schism between its two main product categories; the hearing aids sold through the audiology channel, and cochlear implants, surgical devices marketed to ENTs. This fragmentation has long kept the hearing markets from realizing their potential. The recent merger of Advanced Bionics with Sonova is a major step toward bridging the chasm in the hearing impairment industry, and perhaps in beginning to change its dynamics.

Apnex Medical raises $30mm in first venture round

Deal summary reprinted from Strategic Transactions - December 2009

Device start-up Apnex Medical grossed $16.1mm in its Series A financing, which included Domain Associates, New Enterprise Associates, Polaris Venture Partners, and individual investor and company chairman Michael Berman. Members from each VC firm join Apnex's board. Read more...

Vertos Medical's Blue Ocean Opportunity

Article preview reprinted from IN VIVO -  November/December, 2009  

Given how many start-up companies and their investors have rushed into spine over the past decade or so, one might assume that getting spine surgeons to adopt new technology is relatively easy. - But less than five years after the launch of the first artificial disc was supposed to usher in the era of motion preservation, surgeons are still arguing for the benefits of fusion over disc replacement--underscoring the tension between new devices and traditional therapy options. But one start-up, Vertos Medical Inc., has found a creative way around the adoption issue. Promoting a novel approach to spinal stenosis, Vertos' solution is to focus on the patient, rather than the surgeon, treating stenosis earlier in the continuum of care by reaching out to a new clinical specialty, interventional pain physicians. Read more...

Selling Comparative Effectiveness: Practice May Need Positive Branding

Full article reprinted from "The Gray Sheet" - December 21, 2009

With the national infrastructure for comparative effectiveness research set to expand, the government should be thinking about how to get out a positive message about the oft-maligned practice, policy experts say. Read more...

NICE To Seek Candidates For New-Tech Evaluation Program In First Half Of '10

Article reprinted from "The Gray Sheet" - December 21, 2009

Device and diagnostics companies should start thinking about products they would like to offer for evaluation under a new program in the U.K. Read more...

CDRH To Abandon Bad Precedents On Path To Predictable 510(k)s

Article reprinted from "The Gray Sheet" - December 21, 2009

FDA's device center wants to make the 510(k) process more predictable, but one of the first steps to accomplishing this is to break from what CDRH acknowledges are some questionable past decisions, according to a top Office of Device Evaluation official.  Read more...

Roper buys Verathon as part of $356mm deal

Deal summary reprinted from Strategic Transactions - November 2009

Roper Industries (diversified) has purchased medical device company Verathon and traffic software company United Toll Services for a combined $356mm. Together the acquired companies will bring in over $140mm in revenues and $38mm in earnings. Read more...