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

GE, Ford get $336M HHS contract for 50K lower-cost ventilators

The latest deal works out to about $6,720 per ventilator. GE's roughly $64 million contract for 2,410 ventilators detailed earlier this week works out to a little more than $26,000 per device. 

By Nick Paul Taylor • April 17, 2020

Abbott pulls 2020 guidance but expects coronavirus testing gains to show in Q2

"We haven't seen a quarter or any time quite like this before," new CEO Robert Ford told investors on an earnings call, during which he also addressed comments by some Trump administration officials on testing capacity.

By Greg Slabodkin • April 16, 2020

Boston Scientific to begin selling cheaper ventilator alternative

The "cereal box"-sized device OK'd by FDA will sell for a fraction of the price Philips is charging the U.S. government for its ventilators.

By Nick Paul Taylor • April 16, 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

Device to wean COVID-19 patients off ventilators gains EUA

FDA said the Synapse Biomedical diaphragm stimulator could cut the time easing patients off the breathing support devices from four days to 2.6, with less time on a ventilator also cutting risk of secondary pneumonia.

By Susan Kelly • April 15, 2020

Abbott enters coronavirus antibody testing fray

The company will begin shipping tests tomorrow and plans to request an emergency use authorization from FDA, a status two new serology tests achieved Tuesday.

By Maria Rachal • April 15, 2020

Philips launches scaled-down ventilator, inks production deals to boost output

The medtech has allied with smaller players Flex and Jabil with a goal of 4,000 units per week by the third quarter and is also rolling out an alternative to its full-featured critical care breathing devices amid the coronavirus pandemic.

By Nick Paul Taylor • April 15, 2020

GE, Medtronic, ResMed among 7 medtechs part of $1.4B in finalized HHS ventilator contracts

Building on more than $1.1 billion announced for GM and Philips last week, the latest batch of contracts are aimed at producing over 64,000 of the potentially life-saving devices for COVID-19 patients.

By Maria Rachal • 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

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

J&J blames pandemic for medical device sales slump

CEO Alex Gorsky told investors Tuesday the company expects COVID-19 headwinds to continue "while elective procedures are deferred and hospital resources are redeployed to address patients impacted by this pandemic." 

By Nick Paul Taylor • April 14, 2020

The latest coronavirus shortage: hospital infusion pumps

A surge in COVID-19 cases is not only straining the supply of the devices that administer medications and fluids, but the potentially risky tubing that allows them to be situated in hallways to create distance from sick patients' rooms.

By Greg Slabodkin • April 14, 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

Medtechs adapt to new sales reality amid halt on elective surgeries, hospitals' financial stress

Device manufacturers can't control how long COVID-19 shuts down the procedures and traditional sales models they depend on. But their flexibility during the down period can make or break the restart, industry advisers say.

By Maria Rachal • April 9, 2020

Over 90% of 1M Abbott coronavirus tests sitting idle, White House official says

Deborah Birx, coronavirus response coordinator, said Abbott's testing kits were only able to run 88,000 tests in three weeks because labs don’t have the resources to operate the company's high throughput systems at full capacity.

By Greg Slabodkin • April 9, 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

Coronavirus chaos ripe for hackers to exploit medical device vulnerabilities

Interpol warned that cybercriminals are using ransomware to target healthcare organizations already overwhelmed by COVID-19, and noted a significant increase in detected health system attacks since the start of the pandemic.

By Greg Slabodkin • April 8, 2020

HHS, CVS, Walgreens get behind Abbott's coronavirus test

HHS has ordered 1,200 of Abbott's portable testing instruments and more than 30,000 of the point-of-care, quick-turnaround tests. The big retail pharmacy chains are also adopting the product as they expand drive-thru testing.

By Maria Rachal • April 8, 2020

OraSure wins BARDA contract for in-home coronavirus self-test

The test could become the first authorized by FDA for use at home to detect the virus, but its development won't likely be complete for at least another four to six months.

By Susan Kelly • April 8, 2020

Digital health rakes in record $3.1B in Q1, but coronavirus slump may loom

"Though some of the economic blow will be tempered by demand for connected healthcare, we do not anticipate investment activity to keep pace with Q1 levels in the coming months," a new Rock Health report says.

By Rebecca Pifer • April 7, 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