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Briefly Noted Fibroid study shows positive data Three-year data from the largest, multi-center, prospective voluntary registry on any procedure for benign uterine fibroids showed that 90% of the women participating [...]

Washington roundup CMS: 'no' to FDG-PET coverage, for lack of assessment criteria By MARK McCARTY Medical Device Daily Washington Editor CMS has the unenviable task of deciding which treatments and [...]

Washington roundup FDA: Arrow facing stiff action if its quality problems persist A Medical Device Daily Staff Report Arrow International (Reading, Pennsylvania), a maker of various catheters for cardiac and [...]

No increase in calls, complaints ombudsman's report indicates By MARK McCARTY Medical Device Daily Washington Editor Les Weinstein has held down the job of ombudsman at FDA's Center for Devices [...]

Local economics driving broad DRA crackdown vs. med-tech By MARK McCARTY Medical Device Daily Washington Editor ARLINGTON, Virginia — On the first day of the Medical Device and Diagnostics Marketing [...]

Firms continue to stumble over QSRs, design validation issues BY MARK McCARTY Medical Device Daily Washington Editor WASHINGTON — The Quality Systems Regulations (QSRs) that FDA uses to help device [...]

Agency to hold May hearing FDA pledges spring release of draft guidance for DES trials By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- FDA's two-day hearing in December [...]

Briefly Noted WorldHeart seeks transfer WorldHeart (Oakland, California) has submitted an application to transfer the listing of its common shares to the Nasdaq Capital Market. Last month WorldHeart received a [...]

Briefly Noted Clinical Data to discuss testing regulation Clinical Data (Newton, Massachusetts) said it has received a letter from the FDA regarding the regulation of genetic testing. The letter invited [...]

2nd of two articles Industry: MDUFMA2 must have clearer linkage to investment By DON LONG Medical Device Daily Managing Editor MDUFMA, the user fee program that was intended to help [...]

Revising IPPS Add-on payment may, or may not, benefit new tech uptake By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor The medical device industry over the past decade has [...]

Briefly Noted BriteSmile to appeal Nasdaq delisting notice BriteSmile (Walnut Creek, California), a provider of teeth-whitening systems, said it has received a notice from the staff of the Nasdaq Stock [...]

Court report Judge dismisses 2 of 7 claims brought by SEC vs. Scrushy A Medical Device Daily Staff Report The judge in the civil lawsuit brought by the federal government [...]

Court report Guidant, St. Jude subpoenaed; Scrushy in new indictment A Medical Device Daily Staff Report Guidant (Indianapolis) and St. Jude Medical (St. Paul, Minnesota) both have received subpoenas from [...]

Report from Europe Biosensors signs three firms to distribute its Axxion DES A Medical Device Daily Staff Report Biosensors International Group (Singapore) reported agreements with three additional medical device distributors [...]

Boston Scientific receives its 2nd FDA warning this month By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor For the second time in a month and third time in a [...]

Court report Utah Medical: FDA ‘refusal to cooperate' postpones trial By DON LONG Medical Device Daily Managing Editor The ongoing skirmish between the Utah Medical Products (UTMD; Midvale, Utah) and [...]

House passes MDUFMA fix; Senate vote expected soon WASHINGTON - On Tuesday evening, the House of Representatives passed its fix for the Medical Device User Fee and Modernization Act (MDUFMA). [...]

Senate committee offering up plan to stabilize FDA user fees By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - Medical device companies soon may be able to breathe a [...]

CDRH annual report for FY04 shows drop-off in submissions By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - Has the FDA medical device user fee program put a damper [...]

MDMA annual meeting FDA is ramping up watchdog look at DTC ads for devices By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - In ever-increasing numbers, consumers - not [...]

MDMA annual meeting FDA 'open' to revamp of user fees, Crawford tells group By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - Acting FDA commissioner Lester Crawford said yesterday [...]

Medtech Investing Conference Choice of regulatory paths, relationship-building are key By JIM STOMMEN Medical Device Daily Executive Editor MINNEAPOLIS - So you're running - or perhaps funding - an early-stage [...]

Proposed bill would form new FDA watchdog safety division By AARON LORENZO Medical Device Daily Staff Writer WASHINGTON - The FDA's watchdog powers could expand substantially if some lawmakers on [...]

Senate postpones vote on FDA head after anonymous allegations A Medical Device Daily Staff Report Anonymous allegations against Lester Crawford, President George Bush's choice to head the FDA, prompted the [...]

Commentary: Masimo-Nellcor isn't about pulse oximetry, but instead is a matter of market access It always is interesting to see how two companies can spin the same news so differently. [...]

MDMA: Masimo victory a step vs. 'anti-competitive' GPOs By DON LONG Medical Device Daily Managing Editor The Medical Device Manufacturers Association (MDMA; Washington) last week issued a statement hailing Masimo's [...]

Sarbanes-Oxley receiving more frequent citings in financials By DON LONG Medical Device Daily Managing Editor There's a new sheriff in town. Or at least, as a sort of proxy, one [...]

AdvaMed 2005 annual meeting Panel: In order to avoid pitfalls, start reimbursement drive early By JIM STOMMEN Medical Device Daily Executive Editor DANA POINT, California - The road to reimbursement [...]