Medical Devices Today

NVCA Offshoot to Lobby For VCs and Start-Ups

Article preview from Start Up- October, 2010

The National Venture Capital Association has formed the Medical Innovation and Competitiveness (MedIC) Coalition, to push for more recognition for start-ups developing new devices and therapeutics as well as the venture investors that back them.

FDA To Rescind A 510(k): Rare Action Targets ReGen's Menaflex Device

Article preview from "The Gray Sheet" - October 18, 2010

FDA says it will seek to rescind a much-scrutinized 510(k) clearance of an implantable knee device, initiating a rarely used regulatory authority that some in industry argue does not exist.

Former Director Of FDA's 510(k) Staff To Join Trade Group MDMA

Article preview from "The Gray Sheet" - October 11, 2010

Heather Rosecrans, erstwhile director of FDA's 510(k) pre-market program staff, is joining the Medical Device Manufacturers Association to work on regulatory policy for the industry lobbying group.

Industry Takes Aim At Several Proposals In FDA’s 510(k) Report – Comments

Article preview from "The Gray Sheet" - October 6, 2010

Device manufacturers are lining up against a number of FDA's proposed reforms to its 510(k) pre-market notification process, saying they could harm, not help, the agency’s public health mission.

AdvaMed Supports Splitting Up Class II Devices, But On Its Own Terms

Article preview from "The Gray Sheet" - October 04, 2010

Medical device makers are sending FDA a message that while they support some formal distinctions within the broad range of Class II devices, the creation of a "Class IIb" subset goes too far.

Justice Dept, Inspector General To Target Individuals In Off-Label Cases

Article preview from "The Gray Sheet" - September 29, 2010

The government's chief litigators are not mincing words: They plan to hold more health care execs personally responsible for crimes at their firms.

In Glaucoma, Devices Go Eye-to-Eye with Drugs

Article preview from Start Up - September, 2010

Glaucoma is of serious interest to VCs and strategic investors because of its sheer size; the disease affects 3 million people, most of them managed by drugs. Glaucoma drugs have created a $4 billion market, but have several problems, the greatest of which is non-compliance. Glaukos and other device companies aim to introduce devices that are safe and efficacious enough to compete directly with drugs, rather than standing in as an alternative to today's glaucoma surgeries reserved for end-stage patients. Glaukos recently marked a first of its kind victory; with a tiny implantable ophthalmic stent, Glaukos emerged from a PMA clinical trial that convinced an FDA panel of the benefit-to-risk ratio of its approach when used as a first-line therapy in a select group.

Device Center Increases Advertising/Promotion Enforcement Staff

Article preview from "The Gray Sheet" - September 22, 2010

FDA's device center will increase its focus on advertising and promotion enforcement efforts, as well as policy development, with recently expanded staff resources.

FDA User Fee Renewal Effort Should Include Pre-Market Refinements, Industry Says

Article preview from "The Gray Sheet" - September 15, 2010

Patient and consumer advocates are suggesting FDA request considerably more funding from device companies in the next round of user fee negotiations, but companies are reluctant to foot more of the bill for device reviews without seeing promised improvements in FDA's pre-market program.

Industry Coalition To Draft mHealth Guidance For FDA's Consideration

Article preview from "The Gray Sheet" - September 13, 2010

A new industry coalition looking to influence FDA guidance on mobile health technology is seeking additional membership from trade associations and patient advocacy groups.