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Medical Devices

November 18, 2019 | Daily News

FDA cleared for marketing the first duodenoscope with a sterile, disposable elevator component, which is intended to reduce the number of parts that need to be cleaned and disinfected between uses, the agency announced Friday (Nov. 15).

November 13, 2019 | Daily News

Two FDA experts say 2020 presidential hopeful Sen. Elizabeth Warren’s (D-MA) plan to weed out government corruption by restricting how companies share data and information with federal agencies could have a chilling effect on FDA and regulated industries.

November 11, 2019 | Daily News

FDA is laying the groundwork to study how the general public interprets drug promotion.

October 24, 2019 | Daily News

In a new draft guidance published Wednesday (Oct. 23), FDA recommends breast implant manufacturers include a boxed warning and patient decision checklist in the labeling for breast implants.

October 23, 2019 | Daily News

Experts from Harvard Medical School and Yale School of Medicine call for FDA to enhance postmarket evaluation and premarket testing of medical devices approved through the 510(k) pathway -- which would require more investment in technologies that leverage real-world data, and more authority for FDA to mandate postmarket studies and prohibit certain devices from being used as predicates in device clearances.

October 21, 2019 | Daily News

Democratic presidential candidate Sen. Elizabeth Warren (D-MA) wants FDA to elaborate on how it will differentiate between device servicers and device remanufacturers and how it will promote compliance among those that consider themselves servicers but that are in fact remanufacturers.

October 17, 2019 | Daily News

The medical device lobby called on President Donald Trump to seek a repeal of the Affordable Care Act’s medical device excise tax, which is set to kick back into effect at the beginning of 2020.

October 15, 2019 | Daily News

As FDA parries arguments that its approval standards have changed, allowing for therapies to get on the market faster with little evidence, former FDA chief Robert Califf told a group of stakeholders in the data industry that he, too, is worried that a number of new treatments are getting on the market with no actual understanding of clinical benefit and risk.

October 01, 2019 | Daily News

FDA notified device manufacturers, providers and patients on Tuesday (Oct. 1) that connected medical devices and health care networks that use certain communication software are vulnerable to potential cybersecurity attacks.

September 30, 2019 | Daily News

A medical software industry lawyer called out what he sees as “absolutely horrible” and “legally wrong” language in the revised version of FDA’s clinical decision support software (CDS) draft guidance, which clarifies which CDS tools under the provisions of the 21st Century Cures Act are no longer classified as medical devices and thus are not regulated by FDA.

September 27, 2019 | Daily News

FDA is creating new Sentinel Coordination Centers via a five-year contract as part of its bid to grow the agency’s flagship Sentinel System into a vigorous national scientific resource, the agency announced Friday (Sept. 27).

September 27, 2019 | Daily News

FDA on Thursday (Sept. 26) finalized software policy guidance that clarifies which clinical decision support (CDS) tools won’t be considered devices and thus can get around agency enforcement oversight.

September 24, 2019 | Daily News

The use of medical devices in combination with biologic medicines is emerging as a way to ease burdens on patients and reduce health care costs, but the products pose regulatory challenges to FDA, agency drug center director Janet Woodcock told stakeholders Monday (Sept. 23).

September 20, 2019 | Daily News

A Senate Finance Committee task force charged with looking at six expiring health taxes, including the Affordable Care Act’s taxes on medical devices and health insurers, failed to reach a consensus on next steps in a newly issued report.

September 10, 2019 | Daily News

FDA is seeking public feedback on a new framework for evaluating the risks and benefits of weight loss devices such as intragastric balloons or other stomach implants.

August 30, 2019 | Daily News

FDA on Thursday (Aug. 29) urged industry and health care facilities to start using duodenoscopes with disposable endcaps, saying that fixed endcaps are too difficult to keep clean and therefore pose a threat to patients.

August 19, 2019 | Daily News

FDA on Friday (Aug. 16) announced the first-ever approval of a spinal tether device designed to treat a common form of scoliosis in children and adolescents.

August 02, 2019 | Daily News

CMS raises the add-on pay for new technology and provides an alternative path for both breakthrough devices and Qualified Infectious Disease Products to qualify for that add-on pay as part of the final fiscal 2020 hospital inpatient pay rule released Friday (Aug. 2).

August 01, 2019 | Daily News

A recently issued final FDA guidance clarifies key industry questions about how combination product makers should comply with postmarket safety reporting requirements (PMSR), but an industry lawyer said some of the finer points, such as details to be included in foreign event reports and the number of constituent parts in a safety report, will have to be hashed out in practice.

July 29, 2019 | Daily News

Hospitals would have to publicly post pay-specific negotiated prices of their “shoppable services,” including x-rays or caesarean deliveries, under CMS’ proposed 2020 outpatient rule, as the agency also doubles down on its site-neutral and 340B pay cut policies that hospitals have slammed.

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