Medical Devices Today

Managing The Minefield Of Mandatory Clinical Trial Registration

Full article reprinted from "The Gray Sheet" - September 29, 2008

As key portions of the government's new device clinical trial registry requirements went into effect last week, Medtronic clinical research director Lisa Griffin Vincent offered advice on complying with some of the thornier aspects of the law. Find out what she had to say...

Medtronic Warms To Cryoablation With $380 Million Acquisition Of CryoCath

Full article reprinted from "The Gray Sheet" - September 29, 2008

Find out how Medtronic gains a stake in the race to get the first FDA approval of an ablation catheter for atrial fibrillation with its $380 million acquisition of Montreal-based CryoCath, announced Sept. 25.

Employee Retention Problems, Cultural Differences At Play In China

Full article reprinted from "The Gray Sheet" - September 29, 2008

Find out how an informal Ernst & Young survey found it takes a minimum of two years to get basic business operations up and running in emerging Asian markets such as China.

New CDRH Decision Methods Will Be Put To The Test, Starting With Stents

Full article reprinted from "The Gray Sheet" - September 29, 2008

Find out why defining a "new science" for post-market surveillance is a top priority for the FDA device center's post-market group.

Divide Growing Between Strong, Weak Medical Device IPO Companies

Article preview from Start-Up - September 2008

Find out why a growing number of medical device companies that managed to go public over the past few years are finding their market capitalizations slipping away.

The Medical Device Industry's Robust Times: Are They Sustainable?

Article preview from Medtech Insight - September 2008

Notwithstanding an occasional blip, the environment for medical device companies has never been stronger, with robust technology development, company creation rewarded with high levels of private and venture investment, and strong M&A activity all supporting a business model that was born out of the doldrums that device companies found themselves in a decade ago. Still, there are pressures that are straining the current model and raising legitimate concerns, including physician conflict-of-interest charges; regulatory pathways that are trickier and a climate of evidence-based medicine that leads to longer, more expensive trials; and a robust M&A environment that is sustainable only if a next-generation of acquiring companies steps up. Part one of a two-part series. Find out more.

BSX-Spin-out Navilys Charts New Course

Article preview from IN VIVO - September 2008

Find out how Navilyst Medical, one of several properties recently spun out of Boston Scientific, has designs on growing into a large player in the venous access and fluid management industries.

Getinge Resumes Cardiovascular Shopping Spree With Datascope Purchase

Full article reprinted from "The Gray Sheet" - September 22, 2008

Find out how Getinge is continuing to solidify its position in the cardiovascular device market with its $865 million acquisition of intra-aortic balloon pump maker Datascope, announced Sept. 16.

Senate Explores Restrictions On Direct-To-Consumer Device Ads

Full article reprinted from "The Gray Sheet" - September 22, 2008

Find out how the Senate Special Committee on Aging Chairman Herb Kohl, D-Wis., is considering legislation to restrict direct-to-consumer advertising of medical devices.

Chinese Agencies’ Agreement Could Halve Approval Time For U.S. Devices

Full article reprinted from "The Gray Sheet" - September 22, 2008

Find out how Chinese approval time for imported medical devices could be cut in half under an agreement to reduce redundancies between the country's Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) and its State Food and Drug Administration (SFDA).