Medical Devices Today

European “Substances Of Very High Concern” List Published; Now What?

Full article reprinted from "The Gray Sheet" - November 17, 2008

U.S. device manufacturers are pushing for more guidance on ways to comply with new European requirements for devices containing chemicals classified as "substances of very high concern."

Boston Scientific To Start-Ups: Don’t Call Us, We’ll Call You

Full article reprinted from "The Gray Sheet" - November 17, 2008

It is not news that amid the current global financial crisis, individuals and companies alike are tightening their belts.

GAO Drafts 510(k) Report; Talk Grows Of Pre-Market Reform Legislation In ’09

Full article reprinted from "The Gray Sheet" - November 17, 2008

Find out how after some delay, the Government Accountability Office has drafted a report on FDA's 510(k) submissions program, which some expect will recommend reforms to the Class II, medium-risk category of devices.

Deal of the week: MAKO Surgical gets $40mm via private placement; could add $20mm

MAKO Surgical (implants for minimally invasive orthopedic procedures) announced a private placement that could bring in $60mm.

Medical Device Giants Fight For Basic-Level Market

Full translation summary from PharmAsia News - November 10, 2008

At the recent 60th China International Medical Equipment Fair in Suzhou, medical device giants gave emphasis to products suitable for small and medium health care institutions.

Israel's Device Community: Finding New Models as Medtech Matures

Article preview reprinted from IN VIVO - October 2008

Find out about one of the most successful centers of medical device innovation, Israel is wrestling with that success and adopting new models to build on it.

ReGen Biologics’ Collagen Scaffold Goes To FDA Panel Nov. 14

Full article reprinted from "The Gray Sheet" - November 10, 2008

Find out how FDA's Orthopaedic and Rehabilitation Devices Panel will meet Nov. 14 to review an updated 510(k) submission for ReGen Biologics' Collagen Scaffold knee cartilage repair product.

Oxygen Suppliers Get Less-Than-Expected Maintenance Help From Medicare

Full article reprinted from "The Gray Sheet" - November 10, 2008 

 

Find out how CMS threw oxygen equipment firms a curve ball in its final 2009 physician payment regulations by implementing recently-enacted statutory language in a way that reduces reimbursement.

Post-Election Industry Outlook: New User Fees, More Aggressive FDA

Full article reprinted from "The Gray Sheet" - November 10, 2008

Find out how Democrat-controlled government led by President-elect Barack Obama poised to take control, industry experts have begun speculating on the future of device regulation and reimbursement.

Deal of the week: Sorin Group to sell its vascular therapy business

Deal summary reprinted from Strategic Transactions - Otober 2008

Find out how italian investment fund Investimenti e Partecipazioni SPA has made a binding offer for Sorin Group's (cardiovascular and chronic kidney diseases) vascular therapy business unit.