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NuVasive suspends UK sales of Magec rod amid safety concerns
The move comes after regulators called for quarantining affected devices and X-rays for patients within three months to check for end cap separation, although the COVID-19 crisis could delay such actions.
By Nick Paul Taylor • April 2, 2020 -
BD rolls out test to detect coronavirus antibodies
Some experts point to serology tests, which may help identify people who have immunity, as a key tool in U.S. management of COVID-19 going forward. The BD test has already seen significant use in China.
By Susan Kelly • April 1, 2020 -
Explore the Trendline➔
Courtesy of Intuitive Surgical
TrendlineTop 5 stories from MedTech Dive
From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
"200323-Z-IB607-0016" by New Jersey National Guard is licensed under CC BY-ND 2.0
Remote patient monitoring, ventilator payment among CMS flexibility as COVID-19 rages on
As many patients have required ventilators, Medicare will now cover respiratory devices and equipment for any medical reason a doctor determines instead of only under specific conditions.
By Shannon Muchmore • March 31, 2020 -
FDA flags Class I recall of Medtronic brain stent, citing fracture reports
The agency has received at least 50 reports, including of 10 injuries and one death, tied to an issue with the delivery system that places the aneurysm-treating device in the artery.
By Susan Kelly • March 31, 2020 -
High-risk devices with expedited reviews more likely to be recalled, research suggests
As FDA's Breakthrough Devices Program rises in popularity, a JAMA Internal Medicine analysis found almost two-thirds of Class III devices approved with priority review status between 2005 and 2015 were recalled.
By Nick Paul Taylor • March 31, 2020 -
AdvaMed wary of Trump's use of DPA to boost ventilator production
The medtech industry contends the Defense Production Act could strain the supply chain, but the administration says it's "working to sign contracts immediately" with GE, Medtronic, ResMed and other major manufacturers.
By Greg Slabodkin • March 30, 2020 -
Digital health advice from FDA amid coronavirus leaves more questions than answers
While the agency doesn't consider most apps and software systems for COVID-19 public health surveillance and communication to be regulated medical devices, the scope of regulation remains murky.
By Greg Slabodkin • March 27, 2020 -
FDA outlines role for 3D printing in coronavirus response, with some caution
Additive manufacturing has emerged as a tool to help bolster availability of critical devices like ventilators and testing supplies, but the agency said 3D-printed personal protective equipment may not be as effective.
By Nick Paul Taylor • March 27, 2020 -
Small PAMA victory in aid package, but labs remain in 'untenable situation'
Quest, LabCorp and others scaling up U.S. coronavirus testing will see a delay in Medicare payment reductions as part of the CARES Act signed into law Friday, but industry argues labs have been shortchanged on emergency funds.
By Maria Rachal • Updated March 27, 2020 -
FDA OKs anesthesia gas machines as ventilators amid coronavirus shortage fears
GE Healthcare, which has more than 100,000 of its anesthesia devices worldwide, noted differences but acknowledged the "need to weigh the relative risks and benefits to support patients in these unprecedented times."
By Greg Slabodkin • March 26, 2020 -
UnitedHealth says self-swabbing study spurred FDA coronavirus policy change
The agency now allows onsite, self-collection of samples, after a nearly 500-patient study found self-administered tests about as accurate as those carried out by clinicians.
By Nick Paul Taylor • March 26, 2020 -
Medtech industry asks for FEMA's help allocating ventilators to frontlines
AdvaMed said a lead federal agency should be designated to manage distribution of the breathing machines as manufacturers rapidly scale up production in response to the COVID-19 crisis.
By Susan Kelly • March 25, 2020 -
U.S. Centers for Disease Control. "CDC 2019-Novel Coronavirus (2019-nCoV) test kit". Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/about/testing.html.
How health systems are responding as COVID-19 squeezes the medical supply chain
Procurement of supplies will become more difficult if cases surge and federal stockpiles don't trickle down to the state level quickly enough.
By Deborah Abrams Kaplan • March 25, 2020 -
EU regulators propose 1-year MDR delay
The European Commission formally proposed Friday the Medical Device Regulation start date be moved to May 26, 2021. It needs the quick backing of the European Parliament and Council.
By Maria Rachal • Updated April 3, 2020 -
FDA still trying to fine-tune Pre-Cert as pilot enters 2020
The Pre-Cert pilot, which includes Apple, J&J and Fitbit, is moving forward with the agency "working through the nine companies, trying to figure out how they actually do business," FDA's Bakul Patel told MedTech Dive.
By Greg Slabodkin • March 25, 2020 -
Clinical labs, White House tell different stories on testing backlog
The American Clinical Laboratory Association said without sufficient funds from the federal government, commercial labs might be forced to "retrench rather than keep building the capacity that is needed."
By Greg Slabodkin • March 24, 2020 -
MedTech Europe calls for delay of MDR until coronavirus crisis passes
The trade group argued industry is “working relentlessly” on getting devices to healthcare professionals fighting COVID-19, while simultaneously trying to maintain supply of other products, leaving little bandwidth to focus on new regs.
By Nick Paul Taylor • March 24, 2020 -
Jacob Bell/MedTech Dive
FDA eases rules on ventilator makers as Medtronic and Tesla talk
Hardware and software modifications can occur without submission of a 510(k) as traditional medtechs team with other manufacturers to meet coronavirus-driven demand for the devices.
By Nick Paul Taylor • March 23, 2020 -
FDA greenlights expanded remote patient monitoring to keep patients out of coronavirus-slammed hospitals
The agency said it wants to help healthcare providers diagnose and treat patients who remain at home in the midst of the national emergency.
By Susan Kelly • March 20, 2020 -
Lab industry 'alarmed,' says Senate stimulus bill fails to back testing ramp-up
Without $5 billion in assistance, the American Clinical Laboratory Association contends commercial labs are "being set up to perform COVID-19 testing at a loss." A Senate vote could come Monday.
By Greg Slabodkin • Updated March 23, 2020 -
US won't suspend China tariffs during coronavirus outbreak
The tariffs present a risk and additional cost to medical supply chains as the need for critical products grows urgent.
By Shefali Kapadia • March 19, 2020 -
Brian Tucker/MedTech Dive
CMS urges hospitals to put off elective procedures
The guidelines suggest three tiers, with procedures like hip and knee replacements falling into the "consider postponing" category.
By Shannon Muchmore • March 19, 2020 -
Retrieved from Abbott, PRNewswire on March 19, 2020
Abbott latest to get FDA emergency use nod for coronavirus test
It's the seventh medtech to win the agency's emergency use authorization within the last week as the Trump administration attempts to leverage the private sector, including commercial labs, to boost the nation's testing capacity.
By Greg Slabodkin • March 19, 2020 -
New notified bodies trickle in ahead of looming MDR start date
The 12th notified body authorized for MDR work, and the first from Hungary, was listed in the NANDO database Friday: CE Certiso.
By Nick Paul Taylor • Updated March 20, 2020 -
Courtesy of Centers for Disease Control and Prevention
How an 'overwhelmed' Buffalo lab facing coronavirus supply shortage signals nationwide struggles
The Western New York regional public health lab is a microcosm of the insufficient swab and reagent stocks labs face as they attempt to confirm COVID-19 cases and gauge the scope of their region's outbreak.
By Greg Slabodkin • March 18, 2020
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