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Medical Devices

August 16, 2018 | Daily News

An industry lawyer said a newly proposed list of device accessories that FDA thinks could be re-classified as low-risk does not fully embrace requests from industry and a directive from Congress to reduce the regulatory burden related to certain device accessories.

August 14, 2018 | Daily News

Home health providers question how CMS' revamped home health demonstration will help stem fraud when the agency has recognized the high improper pay rate in that sector appears to be driven largely by paperwork problems, and suggest CMS look at alternatives.

August 10, 2018 | Daily News

Women's health experts are skeptical of a newly FDA-approved mobile medical app that keeps track of women's menstrual cycles as a method of contraception.

August 09, 2018 | Daily News

Representatives of the device industry praised FDA for expanding on concepts included in a diagnostic test oversight bill floating on Capitol Hill, such as creating efficient, predictable pathways to market for diagnostic tests; accrediting third-party organizations to help with the review process; and recognizing the effect of special controls, which exempt certain in vitro clinical tests from premarket review.

August 09, 2018 | Daily News

Following years of debate on the issue, FDA is floating a legislative proposal that would cement the agency's authority to regulate high-risk clinical laboratory diagnostics – including laboratory-developed tests and in-vitro diagnostics – under a risk-based framework in which lower-risk tests could go through FDA's new, voluntary precertification pathway.

August 08, 2018 | Daily News

A spokesman for the Advanced Medical Technology Association (AdvaMed) said his organization is reaching out to Colorado voters through local radio, television, print and online networks in a bid to pressure Sen. Michael Bennett (CO) to become the medical device tax-repeal bill’s tenth Democratic cosponsor in the Senate.

August 07, 2018 | Daily News

Senators looking at how to reduce administrative costs in the health system were encouraged by a Harvard professor to consider pushing for more standardized prior authorization procedures, aspects of which were backed by doctors and hospitals as part of a consensus statement released earlier this year along with the insurance lobby and BlueCross BlueShield Association.

August 03, 2018 | Daily News

Key questions loom regarding FDA's plan to offer select sponsors of opioid treatment and prevention devices special treatment in the review process, including what reimbursement pathways may be available, how many sponsors FDA will select and how the streamline review approach will differ from the breakthrough designation.

August 03, 2018 | Daily News

FDA this week notified seven device manufacturers that their products are being inappropriately marketed for unapproved “vaginal rejuvenation” procedures, such as treating conditions and symptoms related to menopause, urinary incontinence or sexual function.

July 31, 2018 | Daily News

Fearing Chinese retaliatory tariffs and the ensuing price hikes, medical device manufacturers urged U.S. States Trade Representative (USTR) Robert Lighthizer to remove medical devices and technology from a proposed list of goods for which an additional 25 percent tariff would be imposed.

July 26, 2018 | Daily News

Pacific Research Institute released a report critiquing CMS' competitive bidding program for durable medical equipment shortly after the agency proposed a rule putting the program on hold as it makes changes that are viewed by suppliers as the strongest examples to date of the agency taking their concerns into account.

July 25, 2018 | Daily News

A spokesperson for the Advanced Medical Technology Association (AdvaMed) said the device-tax repeal bill cleared by the House Tuesday is just two votes shy of Senate passage and held up multiple reasons he and AdvaMed President and CEO Scott Whitaker are confident it will move through the upper chamber this year.

July 24, 2018 | Daily News

The Advanced Medical Technology Association was delighted by a 283-132 vote in the House of Representatives Tuesday (July 24) to repeal the 2.3 percent excise tax on medical devices that had been included as a funding source for the Affordable Care Act. Scott Whitaker, the association’s president and CEO, called the vote a win for American innovation, jobs and patients, and urged the Senate to quickly pass the legislation.

July 20, 2018 | Daily News

Bayer will stop selling and distributing its permanent birth control device Essure after Dec. 31 citing commercial reasons, FDA announced Friday (July 20), coming three months after the agency limited Essure to prescription-only in the face of years of adverse events and congressional pressure to step up its oversight.

July 19, 2018 | Daily News

House Majority Leader Kevin McCarthy (R-CA) on Thursday revealed plans to bring a permanent repeal of the medical device tax, a two-year delay of the health insurance tax, a reversal of the ACA's ban on using tax-preferred accounts for over-the-counter medicine and tweaks to health savings accounts (HSAs) to the floor next week, but sources say he doesn't plan a vote on legislation that would delay the 40 percent tax on high-cost plans (known as the Cadillac tax) or mitigate the employer mandate at this time.

July 16, 2018 | Daily News

A bill that would repeal the Affordable Care Act's controversial 2.3 percent excise tax on medical devices was not among a slew of bills marked up last week by the House Ways & Means Committee, but the measure is expected to come up on the House floor sometime this month.

July 16, 2018 | Daily News

FDA Commissioner Scott Gottlieb called for the creation of a national resource to coordinate the development and use of real-world evidence (RWE) in medical product development and regulatory science in a recent FDA Voice blog post.

July 13, 2018 | Daily News

A lawyer familiar with Supreme Court nominee Brett Kavanaugh and his jurisprudence said the judge, should he be appointed to the high court, would avoid deferring automatically to FDA or other federal regulatory agencies on cases involving matters where Congress has not given clear instructions.

July 13, 2018 | Daily News

A lawyer familiar with Supreme Court nominee Brett Kavanaugh and his jurisprudence said the judge, should he be appointed to the high court, would avoid deferring automatically to FDA or other federal regulatory agencies on cases involving matters where Congress has not given clear instructions.

July 11, 2018 | Daily News

Medical equipment suppliers won’t have to bid for Medicare business next year as CMS hasn’t yet started the next round of bidding and existing contracts run out at the end of the year, according to a proposed rule CMS released Wednesday (July 11), and one agency official said CMS needs time to implement changes to the bidding program laid out in the rule.

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