Medical Devices Today

Device Industry Expects Quicker Path To Market In Exchange For Doubling Of User Fees

Article preview from "The Gray Sheet"-  February 6, 2012

The tentative agreement of $595 million in user fees over five years is more than companies had wanted to spend. But industry negotiators insist it is a good deal, tied to performance goals and process improvements they say will ensure greater speed and predictability in reaching the U.S. market.

510(k) Guidance Footnote May Signal Greater FDA Oversight Of Preclinical Testing

Article preview from "The Gray Sheet"- January 23, 2012

Device industry experts say a seemingly minor footnote to the recent 510(k) program draft guidance could create a new requirement for nonclinical studies.

Solta Medical: In Aesthetics, A New Device Model For An Evolving Market

Article preview from IN VIVO - December, 2011

Solta Medical was formed by the merger of two aesthetic device start-ups targeting the same customer with complementary technologies: Thermage in skin tightening and Reliant in skin resurfacing. Solta Medical’s product and marketing strategy has made it more immune in the economic downturn than its peers in aesthetic energy devices. What’s helped it most these past few years is its reliance on high margin disposables, rather than capital equipment, for the majority of its revenues.

FDA, Industry Haggle Over Price For New User Fee Deal

Article preview from "The Gray Sheet"- January 17, 2012

As of last month, FDA and industry were several hundred million dollars apart, according to recently released negotiation meeting minutes. And insiders suggest the two are still haggling over the total amount companies will need to shell out in the five-year user fee reauthorization.

Changing The Paradigm: 510(k) Draft Guidance May Raise New Questions

Article preview from "The Gray Sheet"- January 9, 2012

New concepts such as “primary predicates” and “reference devices” may be more confusing than clarifying, former FDA staffers say.

FDA issues major new 510(k) guidance

Article preview from "The Gray Sheet"- January 3, 2012

Companies planning to submit a 510(k) anytime in the future have some reading to do. On Dec. 27, FDA issued a hotly anticipated draft guidance to replace the aging documents that have long defined the pathway by which most devices reach the U.S. market.

Jumpstarting US Device Trials

Article preview from Start-Up - November, 2011

FDA released two draft guidance documents and announced a new pilot program last week in an attempt to make it easier for companies to begin clinical trials in the US. The first draft guidance, issued November 10, focuses on streamlining requirements to initiate and make changes to very-early-stage clinical studies, including first-in-human trials, which are now often conducted overseas for breakthrough technologies. As part of that effort, FDA is also launching a pilot program where selected sponsors will seek to initiate early feasibility trials, including first-in-human studies, by applying the draft guidance recommendations.

Lombard Medical: At Long Last, Turning The Corner In EVAR

Article preview from IN VIVO - November, 2011

Lombard Medical’s early efforts to tap into the endovascular AAA market ran into problems as the company’s initial financing strategy left it with too few resources to overcome the challenges that most start-up device companies face. The company’s most recent financing, a VIPE led by UK-investor Abingworth, should see Lombard through FDA approval and launch of its novel EVAR device that is targeted at patients with high degrees of vascular tortuosity. Early clinical data show its device is performing well against competition.

CardioMEMS’ Heart Failure Monitor Foiled At Panel By FDA Inspection Findings Of Study Bias

Article preview from "The Gray Sheet"- December 12, 2011

The firm’s PMA hopes are in question after recommendations made by company nurses to investigators in the CHAMPION trial, uncovered during FDA clinical-site inspections, dominated last week’s advisory panel meeting. The panel voted 6-4 that the benefits of the device do not outweigh its risks.

FDA To Re-Open J&J’s Rejected Sedasys PMA Without Dispute Panel Input

Article preview from "The Gray Sheet"- December 5, 2011

J&J/Ethicon Endo-Surgery and FDA say they have come to an understanding over the firm’s Sedasys computer-assisted personalized sedation system. As a result, the company has withdrawn a formal appeal of FDA’s prior denial of the Sedasys PMA and FDA has agreed to re-review the pre-market submission.