Medical Devices Today

Deal of the week: Abbott pays $2.86bn for Advanced Medical Optics

Deal summary reprinted from Strategic Transactions - January 2009

Abbott is buying all the outstanding shares of ophthalmics company Advanced Medical Optics for $22 each (a 205% premium) in a transaction valued at about $2.86bn, which includes $1.5bn in debt.

Race For FDA Commissioner Almost Over: Will It End With Sharfstein Or Califf?

Full article reprinted from "The Gray Sheet" - January 19, 2009

Find out how the Obama transition team has concluded its search for a new FDA commissioner, stakeholders said late last week.

FDA Issues Guidance On Off-Label Info; Waxman Seeks ‘Re-examination’

Full article reprinted from "The Gray Sheet" - January 19, 2009

Find out how Rep. Henry Waxman is calling for the Obama administration to re-examine a final FDA guidance that gives companies a way to distribute journal articles discussing off-label uses for approved medical devices and drugs.

GAO Report On 510(k) Program Calls For Regulations On 20 Device Types

Full article reprinted from "The Gray Sheet" - January 19, 2009

Find out how a long-awaited government report on the premarket review process for devices says FDA needs to decide "expeditiously" how to review 20 types of devices: through the stringent PMA approval process or through the less rigorous and faster 510(k) clearance process.

Deal of the week: Volcano buys Axsun for $21.5mm in cash

Deal summary reprinted from Strategic Transactions - January 2009

Volcano Corp. (devices for coronary and peripheral artery disease) is paying $21.5mm in cash to acquire private company Axsun Technologies, a developer of MEMS-based lasers and optical equipment used in medical optical coherence tomography (OCT) imaging systems.

Emphysema: Elusive Target for Device Companies

Article preview reprinted from IN VIVO -December 2008

Find out how nearly a decade into the race to arm pulmonologists with interventional tools to treat emphysema, no clear winner is emerging.

Depression Bolsters the Neuromodulation Market

Article preview reprinted Medtech Insight - November 2008

More than a decade ago, venture capitalists identified neurostimulation as a fertile new field for investment, but efforts to date have produced more disappointments than results.

DFine Inc.

Article preview reprinted from Start-Up - December 2008

Find out how spine specialists who perform vertebral augmentation procedures using bone cement can encounter leakage of the cement once it is injected into the fractured vertebral body.

Test Methods Needed To Understand Safety Risks Of Bisphenol A In Devices

Full article reprinted from "The Gray Sheet" - January 12, 2008

Find out how AdvaMed is urging a "methodical, scientific" approach to assessing the use of bisphenol A in medical devices, in the face of public concerns that the leachable chemical could pose health risks.

Hospital-Acquired Infections Targeted In HHS Action Plan

Full article reprinted from "The Gray Sheet" - January 12, 2008

Find out how HHS' ¹draft action plan for the prevention of hospital-acquired infections outlines a broad research agenda that includes developing strategies for avoiding device-related infections and ensuring optimal use of products like antimicrobial catheters.