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Medical Devices

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.

July 06, 2018 | Daily News

Top FDA officials, including FDA Commissioner Scott Gottlieb, reaffirm the need for a new regulatory framework for software as a medical device (SaMD), which they hope will help ease the regulatory uncertainty surrounding such products, increase consumer confidence in the technology, help payers and investors understand the technology, and allow the agency to keep up with the fast pace of software development.

July 06, 2018 | Daily News

Industry lawyers say FDA's ambitious goal of reviewing quickly evolving software-based medical devices in potentially 10 days or less is easier said than done, and requires a cultural shift in the agency from a purely science-based mindset to a business and organizational one.

July 03, 2018 | Daily News

A major hospital group says FDA needs to step up and mandate cybersecurity for medical devices, a move intended to address risks related to legacy products that can't be updated or adequately patched as Congress considers steps to protect patients from cyber attacks.

June 29, 2018 | Daily News

Device industry groups continue to express their strong support for a bill, cosponsored by more than half of the House, that would repeal a controversial 2.3 percent excise tax for medical devices, and one technology company representative said she heard from House Majority Leader Kevin McCarthy (R-CA) that the bill will be brought to vote in July.

June 22, 2018 | Daily News

A representative of an independent device service organization called out other ISOs for servicing medical devices without proper equipment or training, a concern which FDA said in a report released last month did not have enough evidence to be considered a widespread public health risk.

June 18, 2018 | Daily News

Senators from both parties urged FDA Commissioner Scott Gottlieb to keep up the pressure on CMS to add medical device identifier information to Medicare claims forms, a change which FDA expressed support for in the Medical Device Safety Action Plan it released in April.

June 15, 2018 | Daily News

FDA's decision to adopt a hands-off approach on medical device servicing has refueled congressional interest in legislation to beef up federal oversight of the industry, a spokesperson for the House Energy and Commerce Committee told Inside Health Policy.

June 15, 2018 | Daily News

The Medical Imaging & Technology Alliance (MITA) is working with device industry stakeholders on a nationwide voluntary standard for the servicing of medical devices, coming as FDA advocates a hands-off regulatory approach toward servicers, a MITA policy expert told Inside Health Policy.

June 12, 2018 | Daily News

In a policy reversal, Medicare will let seniors use an FDA-approved mobile app to send results from continuous glucose monitors to their doctors, families and caregivers. James Scott, president and CEO of Applied Policy, said the change sets a positive precedent for Medicare coverage of remote patient-monitoring technologies.

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