Medical Devices Today

Reform In Japan: Reviewers And Fees Go Up; Will Approval Times Go Down?

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

Find out how U.S. device manufacturers hope an "action program" adopted by the Japanese government Dec. 17 and tied to increased industry user fees will significantly speed device approval times there.

Genentech Petition Rekindles Debate On Lab-Developed Test Regulation

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

Find out how a citizen petition from biotech giant Genentech is adding new fire to the debate over whether FDA should regulate more laboratory-developed tests, and under what authority.

AdvaMed Code Of Ethics Make-Over: More Restrictions, More Guidance

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

Find out how AdvaMed's updated industry "code" for interacting with health care professionals forbids device firms to provide entertainment, recreation and non-educational gifts of any value, including pens, mugs and notepads.

Medtech Venture Capital Heads into Unfamiliar Terrain

Article preview reprinted from Start-Up - November 2008

Find out how the landscape in medtech investing is changing, and one need only look at two signposts to see that this is so: the exit values of VC-backed companies over the past eight years (lower than anticipated), and the amount of time required to achieve those exits (longer than ever before).

Cardiac Assist: Pumping up the Heart Failure Market

Article preview reprinted Medtech Insight - November 2008

Find out how after struggling for years to gain momentum, the ventricular assist device market appears finally to be coming of age.

American Chamber of Commerce Pinpoints Delays In Japan’s Medical Device Commercialization

Full translation summary from PharmAsia News - December 15, 2008

American Chamber of Commerce of Japan released results of a survey Dec. 8 that compares drug commercialization timelines in the U.S. and Japan.

Female Condom Redesign Gets FDA Panel Endorsement

Full article reprinted from "The Gray Sheet" - December 15, 2008

Find out how the Female Health Company's update of its Reality female condom, which uses a different material and manufacturing process to lower costs, should be approved by FDA contingent upon a single labeling change, the agency's Obstetrics and Gynecology Devices Panel recommended Dec. 11.

PMA Supplement Guidance Finally Finalized, But Questions Remain

Full article reprinted from "The Gray Sheet" - December 15, 2008

Find out how FDA finalized guidelines Dec. 11 explaining what PMA supplement submissions are required for certain product modifications, largely mirroring 2007 draft guidance that device makers considered "incomplete."

Massachusetts Proposes Regs For Nation’s Strictest Sales, Marketing Law

Full article reprinted from "The Gray Sheet" - December 15, 2008

Find out how a Dec. 10 proposal for implementing a Massachusetts device and pharmaceutical marketing law contains some concessions for industry but would still impose the strictest rules for medical device marketing in the nation.

Deal of the week: Apeliotus raises $500k in seed round · November 2008

Deal summary reprinted from Strategic Transactions - November 2008

Find out how Start-up diagnostic company Apeliotus Vision Science has received $500k from Life Sciences Greenhouse of Central Pennsylvania in the first tranche of its planned $2mm seed financing.