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

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Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

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

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

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

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

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

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

MedTech Europe sounds alarm over 'inconsistent' enforcement amid flurry of MDR updates

A lack of harmonized standards worries the trade association. Meanwhile, the Medical Device Coordination Group issued new documents on software requirements, implant cards and unique device identifiers.

By Nick Paul Taylor • March 18, 2020

As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

The Medical Device Coordination Group acknowledged implementation “has proven to be a very challenging task” but for now appears to be pushing ahead with the planned May start date.

By Nick Paul Taylor • March 17, 2020

Hologic, LabCorp win emergency use nods as FDA eases rules to boost US coronavirus test volume

In some cases, manufacturers can distribute, and labs can use, new commercially developed tests prior to an emergency use authorization.​ FDA's updated policy also boosts states' authority to greenlight tests.

By Greg Slabodkin • March 17, 2020

To fight coronavirus spread, high-throughput tests bring potential benefits, challenges

Deborah Birx, White House coronavirus response coordinator, said labs will just as importantly need supplies to ramp up testing. The American Clinical Laboratory Association is concerned about potential supply shortages.​    

By Greg Slabodkin • March 15, 2020

Thermo Fisher coronavirus test gets FDA nod

Trump administration officials promised on Sunday that 2,000 labs would be running 1.9 million tests this week. Separately, the American Clinical Laboratory Association expects daily testing capacity to exceed 20,000 next week, with the potential to grow to 280,000 by April 1.  

By Maria Rachal • March 15, 2020

Trump declares national emergency, opening up billions for coronavirus

The president also teased an imminent FDA emergency use authorization for a test from Thermo Fisher, with LabCorp and Quest saying they're collaborating with Roche.

By Samantha Liss • Updated March 13, 2020