Policy & Regulation: Page 3


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    Deep Dive

    How Morgan Health hopes to finally move the needle on employer health costs: 5 insights from a chat with the venture's CEO

    Morgan Health learned a lot from Haven, but is a different beast with better knowledge of the buy-in needed to disrupt the health benefits space, CEO Dan Mendelson told Healthcare Dive.

    By Rebecca Pifer • Oct. 8, 2021
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    Deep Dive

    Will a software bill of materials help or hurt medical device cybersecurity?

    President Joe Biden's executive order calls for SBOMs, and the FDA wants to require premarket submissions to have an inventory of third-party device components. AdvaMed is concerned the data could be exploited by hackers.

    By Oct. 7, 2021
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    Trendline

    COVID-19 diagnostics surge as industry prepares for spike in at-home testing

    With strong demand once again for rapid at-home coronavirus tests, medtech companies are looking beyond COVID-19 to sell over-the-counter and direct-to-consumer diagnostics for other diseases. 

    By MedTech Dive staff
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    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.

    Labcorp, PerkinElmer latest to target COVID-flu combo test market

    FDA gave a nod to Labcorp's diagnostic, which uses a Roche test for SARS-CoV-2, influenza A and influenza B. PerkinElmer's assay also got emergency authorization for those three viruses as well as respiratory syncytial virus.  

    By Oct. 7, 2021
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    Courtesy of Ellume Health

    FDA labels Ellume's recent COVID-19 Home Test recall Class I event

    The agency said there have been 35 reports of false positive results but no deaths reported. More than 2.2 million devices are being recalled in the U.S.

    By Updated Nov. 10, 2021
  • EU shares guide to MDR's 22 rules for classifying medical devices

    If a manufacturer and notified body dispute a classification, the case may be referred to the competent authority in the country where the company has its registered place of business.

    By Oct. 6, 2021
  • Medtronic expands 2 MiniMed insulin pump recalls on ring flaw, cyber risks

    The recalls have hit the medtech giant at a time when competitors Insulet and Tandem are ramping up in the insulin pump market and amid flagging sales in its diabetes unit.

    By Oct. 5, 2021
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    FDA resists industry push to nix De Novo inspections in final rule

    "The most controversial aspect was FDA's provision for ... an FDA inspection for what is tantamount to a 510(k)," noted Bradley Merrill Thompson, attorney at the law firm Epstein Becker Green.

    By Oct. 5, 2021
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    Jose Luis Pelaez Inc/Blend Images

    Doctors slam surprise billing rule that details dispute resolution process

    Making a health plan's "qualifying payment amount" the primary factor in independent dispute resolution arbitration will "cause large imaging cuts and reduce patient access to care," the American College of Radiology said.

    By Shannon Muchmore • Oct. 5, 2021
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    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.

    Acon gets FDA nod for home COVID-19 test kit amid surging US demand

    The diagnostics maker secured authorization for its over-the-counter antigen test amid a nationwide testing shortage. Abbott and Quidel are scaling up production but it could take months to boost output.

    By Oct. 5, 2021
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    Sarah Silbiger via Getty Images

    FDA's real-world evidence push hampered by data challenges, 'million-dollar question'

    While the agency wants to tap information like electronic health records and wearables to make pre- and postmarket decisions, these sources do not have the same quality controls as clinical trials. 

    By Oct. 4, 2021
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    Sarah Silbiger via Getty Images

    FDA hits nearly all MDUFA IV commitments despite pandemic disruptions

    The main black mark in an audit was the failure to publish draft guidance on content for premarket submissions for software in a medical device.

    By Oct. 4, 2021
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    Retrieved from AdvaMed on October 04, 2021

    MCIT, cyber, RWE and 3 more takeaways from AdvaMed's 2021 conference

    The medtech industry gathered virtually and in person for the lobby's annual conference, with topics ranging from the kill-off of the breakthrough device payment pathway to the pandemic upending CDRH's 2021 reset.

    Oct. 4, 2021
  • Ransomware attacks put availability of medical devices at risk: FDA cyber chief

    Industry reached a "watershed moment" earlier this year when a device outage caused by malware endangered patient lives, Kevin Fu, acting director of cybersecurity at CDRH said. "That was something we haven't seen before."

    By Oct. 1, 2021
  • How much is too much? OIG warns about booze for doctors in medtech speaker programs

    "This is a chance to take a hard look and see if it's worth it. The document may signal that some types of practices are just too risky," said Ben Wallfisch, a senior counsel with the Office of Counsel to the HHS Inspector General. 

    By Kim Dixon • Oct. 1, 2021
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    Sarah Silbiger via Getty Images

    Siemens gets FDA clearance for 'major' improvement to CT imaging

    The agency hailed the device's photon-counting detectors as the "first new major technological improvement" in computed tomography imaging in a decade. Rivals like GE Healthcare may not be far behind.

    By Oct. 1, 2021
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    Bayer posts final analysis of Essure adverse events to FDA

    The last report, which is based on social media posts, completes the deal the company made with the agency.

    By Sept. 30, 2021
  • MedTech Europe director warns about EU's turbulent switch to IVDR

    Oliver Bisazza told the AdvaMed conference this week that while the European Union will "needlessly lose a great deal of tests" in the transition to the In Vitro Diagnostic Regulation, he is confident decision makers will "course correct."

    By Sept. 30, 2021
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    CMS defends proposal to nix MCIT pathway, medtechs hold out hope

    If the bid to repeal the breakthrough payment rule is finalized, the agency's CMO committed to an alternative pathway that evaluates devices for Medicare patients potentially via clinical trials, outcome registries and real-world data.

    By Sept. 29, 2021
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    Sarah Silbiger via Getty Images

    FDA medical device regs, safety checks questioned by AMA ethics journal

    As it's typically safer to discontinue the use of a drug than an implant, it "might be reasonable" to hold some devices to higher standards, suggests Ariel Wampler, author and plastic and reconstructive surgery physician.

    By Sept. 29, 2021
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    Danielle Ternes

    CDRH's 2021 'reset' shunted again as COVID-19 dominates workload

    Jeff Shuren, who spoke during AdvaMed's annual conference, said the heavy coronavirus workload will lead it to miss some MDUFA IV performance metrics.

    By Sept. 28, 2021
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    Sarah Silbiger via Getty Images

    FDA starts review after study finds Boston Scientific's Watchman is riskier in women

    The agency is working with manufacturers of LAAO devices, a market fought over by Boston Scientific and Abbott, to assess other sources of data before deciding on the next steps.

    By Updated Sept. 29, 2021
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    Delta pressure on US hospitals dragged August operations, Kaufman Hall finds

    "The August data show we are not out of the woods yet, and hospitals face additional uncertainties as we move into the fall and winter," said Erik Swanson, senior vice president of data and analytics for the consultant group.

    By Rebecca Pifer • Sept. 28, 2021
  • Amid pandemic, medtech R&D, merger activity jumped: EY report

    Research and development spending at pure-play medtechs rose to a level last seen before the 2007-2008 financial crisis.

    By Sept. 27, 2021
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    Medtechs face supply chain disruptions from semiconductor shortage: report

    The AdvaMed-commissioned survey found all respondents have experienced some level of disruption to their chip supply chain, with delays ranging from two weeks to more than one year.

    By Sept. 24, 2021
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    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.

    FDA tells COVID-19 test makers to assess impact of variants in new EUA conditions

    The agency's order to assess performance comes amid renewed focus on testing that's seen manufacturers add capacity and land contracts with the federal government worth more than $1 billion.

    By Sept. 24, 2021