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.
Continue reading "NVCA Offshoot to Lobby For VCs and Start-Ups" »
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.
Continue reading "FDA To Rescind A 510(k): Rare Action Targets ReGen's Menaflex Device " »
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.
Continue reading "Former Director Of FDA's 510(k) Staff To Join Trade Group MDMA" »
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.
Continue reading "Industry Takes Aim At Several Proposals In FDA’s 510(k) Report – Comments" »
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.
Continue reading "AdvaMed Supports Splitting Up Class II Devices, But On Its Own Terms " »
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.
Continue reading "Justice Dept, Inspector General To Target Individuals In Off-Label Cases " »
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.
Continue reading "In Glaucoma, Devices Go Eye-to-Eye with Drugs " »
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.
Continue reading "Device Center Increases Advertising/Promotion Enforcement Staff " »
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.
Continue reading "FDA User Fee Renewal Effort Should Include Pre-Market Refinements, Industry Says " »
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.
Continue reading "Industry Coalition To Draft mHealth Guidance For FDA's Consideration " »