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

Explore the Trendline➔

Top 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

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

CDC chief: Reagents critical to coronavirus tests​ 'now are in short supply'

Separately, the government Friday announced funding for development of COVID-19 diagnostic tests from DiaSorin Molecular and Qiagen meant to detect the pathogen in about an hour. 

By Greg Slabodkin • March 13, 2020

As US officials shift tone on coronavirus, Trump stops short of 1 provider ask

The president did not declare a disaster or national emergency, which groups like the American Hospital Association had sought.

By Samantha Liss , Shannon Muchmore • March 12, 2020

TransMedics stock falls double-digits as PMA meeting again delayed by FDA

The "unforeseen delay," according to the company's CEO, further pushes back the advisory panel review of the company's heart transplant device.

By Maria Rachal • Updated Sept. 29, 2020

FDA chief warns of supply 'pressure' on reagents for coronavirus tests

Qiagen, a major supplier of RNA extraction kits, confirmed to MedTech Dive Thursday that "extraordinary demand for coronavirus testing workflows" is challenging the company's capacity.

By Greg Slabodkin • March 12, 2020

FDA finalizes contentious guidance on third party 510(k) reviews

Meant to enable faster decisions and free up the agency to focus on higher risk devices, earlier versions took fire from AdvaMed and some patient groups.

By Nick Paul Taylor • March 12, 2020

White House, CDC under fire for availability of coronavirus tests

The Trump administration is facing criticism that federal agencies did not engage the big private labs early enough in the public health emergency.

By Greg Slabodkin • March 11, 2020

FDA issues Class I recall for Medtronic's HeartWare HVAD after patient death

A design flaw flagged by Medtronic in January regarding its ventricular assist devices landed a high-risk label from regulators this week.

By Nick Paul Taylor • March 11, 2020

Key EU notified body meeting goes on, virtually

A Medical Device Coordination Group meeting, parts of which are postponed, comes as Germany, home to four of 11 notified bodies designated under EU MDR, anticipates widespread COVID-19 transmission.

By Nick Paul Taylor , Maria Rachal • March 11, 2020

Coronavirus spread prompts FDA to postpone nearly all overseas inspections

The agency based the decision on U.S. government travel restrictions and advisories, saying "alternative tools and methods" will help maintain oversight.

By Jonathan Gardner • March 10, 2020

FDA updates guidance on 510(k) submissions for electrosurgical devices

The agency offered greater detail on testing requirements in assessing thermal tissue damage.

By Susan Kelly • March 10, 2020

Labs step up capacity to meet demand for nationwide coronavirus testing

The Trump administration is relying on the "enormous capacity" of commercial labs to enable wide availability of COVID-19 diagnostic testing to the American public through physicians offices and pharmacies. 

By Greg Slabodkin • March 10, 2020

Long-awaited interoperability rules finalized by Trump admin, prompt industry ire

Providers and entrenched health IT interests are unlikely to be happy with the final iterations, which largely mirror the proposed versions. One win: The timeline to come into compliance has been pushed back.

By Rebecca Pifer Parduhn • March 9, 2020

ACC 2020 meeting canceled as coronavirus spreads in US

Abbott, Edwards and Medtronic were among the medtechs slated to present data at the American College of Cardiology's annual event. "This is a unique time for us all," the organization wrote in a statement Monday.

By Maria Rachal • March 9, 2020

Cardiologist groups back Abbott push to change heart device coverage

Some feedback to CMS supports a retreat from potentially restrictive terms used with ventricular assist devices. Responses to SynCardia’s separate bid to permit the use of artificial hearts outside of clinical trials were more mixed.

By Nick Paul Taylor • March 6, 2020

$8.3B in coronavirus funding set in motion as federal agencies ramp up response

The House and Senate passed a bill with allocations for medical supplies and testing as Vice President Mike Pence met with clinical lab execs Wednesday from LabCorp, Quest Diagnostics, Thermo Fisher and others.

By Shannon Muchmore • Updated March 5, 2020

UK looks to use Brexit to make device industry more transparent

The House of Commons bill seeks to address a regulatory gap for medical devices, as the previous legal framework is based on EU directives. One element provides new information-sharing powers related to safety.

By Nick Paul Taylor • March 5, 2020

Some pacemakers, EKGs, diabetes devices may face newly flagged Bluetooth cyber risk

FDA and the Department of Homeland Security said microchips from seven manufacturers and a range of consumer wearables and connected medical devices may be affected.

By Susan Kelly • March 4, 2020

FDA bans certain electrical stimulation devices called 'barbaric'

Amid mounting pressure from lawmakers, the agency handed down its third-ever medical device ban, finalizing a 2016 proposal prohibiting current and future sale of certain devices to treat self-injury or aggressive behavior.

By Maria Rachal • March 4, 2020

AdvaMed, Medtronic among top 20 pharma and health product lobbyists over 2 decades: study

The medical devices trade association spent $79.4 million on lobbying from 1999 to 2018, making it the fifteenth biggest spender.

By Nick Paul Taylor • March 3, 2020