LabCorp, Quest expand COVID-19 antibody testing nationwide

Amid the moves by the giant commercial labs, a White House plan released Monday says the administration is still exploring how to improve the reliability of these products.

By Greg Slabodkin • April 28, 2020

FDA encourages remote review of digital pathology slides amid COVID-19

The agency's latest effort to support greater access to medical devices during the pandemic follows a move by CMS that opened the door for pathologists to work away from the lab.

By Susan Kelly • April 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

Gottlieb, Slavitt pitch $46.5B plan for COVID-19 contact tracing, isolation

Primary care doctors should be the main referral source for testing and contact tracing, according to a letter penned by a bipartisan group including former CMS head Andy Slavitt and former FDA Commissioner Scott Gottlieb.

By Shannon Muchmore • April 27, 2020

CMS hits pause on speeding Medicare payments, including for DME suppliers

The Trump administration is suspending accelerated Medicare pay to doctors and durable medical equipment suppliers, and is re-evaluating hospital requests, after another round of emergency funding was signed into law Friday.

By Rebecca Pifer • April 27, 2020

Abbott, DiaSorin coronavirus antibody tests get EUAs as lawmakers question others on market

As more diagnostics assessing possible immunity to the virus win FDA emergency use authorization, criticism is mounting over the accuracy of products the agency allowed on the market without the designation.

By Greg Slabodkin • April 27, 2020

Digital therapeutic makers see opportunity as pandemic prompts FDA to ease rules

Akili Interactive Labs is rolling out its video game treatment for ADHD for the first time, while Pear Therapeutics weighs how products still in its pipeline may apply during the coronavirus crisis.

By Maria Rachal • April 24, 2020

It's official: EU finalizes 1-year MDR delay

The European Commission listed a 13th notified body designated for Medical Device Regulation-related work in its official database Saturday, the first new firm announced in over a month and the fifth based in Germany.

By Maria Rachal • Updated April 27, 2020

FDA moves to boost access to imaging systems during pandemic

The agency is allowing devices to be modified for portable use to enable imaging outside of hospitals in an effort to potentially slow the spread of COVID-19. 

By Nick Paul Taylor • April 24, 2020

FDA grants breakthrough status to heart failure, stent graft tech

The newly disclosed breakthrough device designations follow ones awarded to a speech therapy app and a treatment for stable vertebral compression fractures in recent weeks.

By Nick Paul Taylor • April 24, 2020

MedTech Europe pushes for IVDR delay as MDR hold nears finish line

The trade group warned that "even before the COVID-19 pandemic, very little progress had been achieved" to get the In Vitro Diagnostic Regulation ready, which it said altogether warrants at least a 12-month delay.

By Nick Paul Taylor • April 23, 2020

FDA finalizes post-inspection feedback protocol for medical device makers

The agency kept to a tight turnaround time for companies to submit requests despite AdvaMed's argument for more time to avoid "rushed answers."

By Susan Kelly • April 22, 2020

COVID-19 bill with $25B for lab testing signed into law

The clinical lab lobby praised the legislation, which includes funds for serology and molecular testing.

By Shannon Muchmore • Updated April 24, 2020

CMS, surgeons group offer paths forward to resume elective procedures

Johnson & Johnson, Abbott and Intuitive Surgical are among the device makers that reported the widespread deprioritization of surgeries during the pandemic dented sales at the end of the first quarter.  

By Susan Kelly • April 20, 2020

Patchy IT infrastructure hobbling COVID-19 response, commercial labs and public health officials warn

Labs have to comply with a variety of state and federal reporting laws, all while fielding separate requests for data from state health information exchanges, governors, Medicaid plans, government contractors, and others.

By Rebecca Pifer • April 17, 2020

FDA device review times could get iffy, agency chief says

"It is difficult to speculate on what the exact impact will be on incoming submissions moving forward," Commissioner Stephen Hahn said in an update on hitting MDUFA goals amid the constraints of the public health emergency.

By Maria Rachal • April 17, 2020

EU MDR delay clears Parliament, enters final stages

During a plenary focused on combating the coronavirus pandemic, the European Parliament on Friday voted overwhelmingly in favor of pushing back the regulatory overhaul. A few steps remain.

By Nick Paul Taylor • April 17, 2020

CMS doubles Medicare payment for coronavirus lab tests

The American Clinical Lab Association praised the move to increase reimbursement for high-throughput molecular diagnostics, an effort to speed and expand COVID-19 testing nationwide.

By Greg Slabodkin • April 15, 2020

CMS removes ventilators from DME bidding program due to high coronavirus demand

Needham analysts said companies including ResMed, Hillrom and Inogen may benefit from the policy shift, given non-invasive ventilators could have faced reimbursement cuts as steep as 50% or more.

By Susan Kelly • April 14, 2020

FDA authorizes 1st coronavirus test using at-home collection of saliva samples

The update to an EUA given last month for a test developed at Rutgers allows for at-home collection of specimens for the saliva-based test, although scope of the offering remains somewhat limited for now.

By Maria Rachal • Updated May 11, 2020

FDA EUAs go to 1st blood purifiers for COVID-19 patients, new N95 sterilizers

Terumo and CytoSorbents are behind blood purification devices designed to reduce inflammatory proteins in COVID-19 patients admitted to the ICU with confirmed or imminent respiratory failure.

By Susan Kelly • April 13, 2020

CMS issues guidance to free patients from copays for coronavirus tests

Clinical labs worry Congress hasn't provided funds for the “free testing." But recent legislation gives the labs rates negotiated before the pandemic; or if there wasn't one, allows them to negotiate on price.

By Nick Paul Taylor • April 13, 2020

EU permits remote notified body audits during pandemic

The guidance came the day after the Council of the EU responded to the European Commission's proposal for a one-year delay to the Medical Device Regulation, which Parliament is set to vote on next week.

By Nick Paul Taylor • April 9, 2020

White House official urges caution before assuming coronavirus antibody test accuracy

The FDA last month made it easier for companies to quickly develop serology tests. But the Trump administration’s coordinator for coronavirus diagnostic testing warned against overreliance on the tests before they are validated.

By Greg Slabodkin • April 7, 2020

FDA OKs changes to oxygenation devices to treat coronavirus patients

A surge in patients with the sudden acute respiratory syndrome led to easing of allowed uses for cardiopulmonary bypass devices and ECMO machines. Medtronic and Getinge are among makers of the impacted devices.

By Nick Paul Taylor • April 7, 2020

FDA allows for infusion pump modifications to prevent shortages

In a bid to "reduce supply chain interruptions and manufacturing bottlenecks" during the pandemic, the agency will permit some changes to the pumps and accessories without the added step of a new 510(k) submission.

By Susan Kelly • April 6, 2020