BD sells 750K antigen tests to HHS as COVID-19 nursing home testing scales up

Also included in the government order are 2,000 of BD's point-of-care testing machines to be distributed starting next week in hotspot regions of the U.S.

By Maria Rachal • July 15, 2020

ElectroCore noninvasive nerve stimulator gets EUA for COVID-19 patients with asthma

The small medtech has focused on migraine and cluster headache, but FDA's support could be a first step to developing evidence to back expansion of noninvasive vagus nerve stimulation into reactive airway disease.

By Susan Kelly • July 14, 2020

Quest COVID-19 test turnaround times double for priority patients

In an update late Monday, Quest said that while volumes have "stabilized," average turnaround times are still at least a week and some patients may have to wait for up to two weeks.

By Greg Slabodkin • Updated July 21, 2020

An insider's look at how GM, Ventec ramped up ventilator production amid COVID-19

The weight of the Defense Production Act was key in opening doors, said the CEO of the engineering firm contracted to test each of the 30,000 devices expected under the agreement.

By Greg Slabodkin • July 13, 2020

Shareholder challenges Thermo Fisher's $11.5B deal to buy Qiagen

COVID-19 has made "significantly clearer" the importance of Qiagen's testing business, according to investment management firm Davidson Kempner, which is urging other shareholders to reject the offer priced in early March.

By Susan Kelly • July 13, 2020

Abbott lays out plan for US study of FreeStyle Libre 3

The sign of potential progress on the medtech's next version of its glucose monitoring technology comes about a month after Libre 2 gained FDA's green light, albeit without the OK to integrate with automated insulin delivery systems.

By Maria Rachal • July 13, 2020

Quest Q2 better than feared, as demand surges for COVID-19 diagnostics

The update on April-through-June revenue comes as lab networks' July testing capacity and results turnaround times are strained by regional outbreaks.

By Maria Rachal • July 13, 2020

FDA plans to restart domestic inspections, contingent on local coronavirus trends

The agency is aiming to resume some on-site surveillance the week of July 20 after shutting down non-critical inspections in March due to the COVID-19 outbreak.

By Maria Rachal • July 10, 2020

Lab groups ask Trump admin for more transparency into COVID-19 testing supply allocation

Eight organizations representing laboratory professionals asked the White House Coronavirus Task Force to address ongoing obstacles to performing tests.

By Greg Slabodkin • July 10, 2020

Siemens COVID-19 antibody test beats rivals in head-to-head study

Assays from Abbott, DiaSorin and Roche failed to meet the U.K. public health agency's sensitivity target. None of the tests performed as well as they did in the company-run studies quoted in their instructions for use.

By Nick Paul Taylor • July 10, 2020

Q2 previews show coronavirus diagnostics bump for Thermo Fisher, Quidel, GenMark

Preliminary results suggest near-insatiable demand for COVID-19 tests is offsetting disruption in other parts of the sector.

By Nick Paul Taylor • July 9, 2020

Philips wins $100M tele-ICU contract from VA

The company said it's creating the world’s largest system for providing remote access to critical care expertise, regardless of patient location. 

By Nick Paul Taylor • July 9, 2020

Democrats urge Trump administration to force full payer coronavirus test coverage

The insurance lobby did not refute claims that not all testing is funded in full, particularly for return-to-work programs. Lawmakers said CMS guidance conflicts with legislation meant to spur widespread access to testing.

By Samantha Liss • July 8, 2020

CMS not yet sold on Baxter, Outset tech in kidney care payment proposal

The agency said the need for more at-home care has never been more urgent, as the end-stage renal disease population has the highest rate of hospitalization due to COVID-19 among Medicare beneficiaries.

By Samantha Liss , Maria Rachal • July 8, 2020

Labs, ASCs get slice of $521B in COVID-19 paycheck protection loans

Federal dollars flowing to hundreds of ambulatory surgery centers could benefit medtechs hoping outpatient facilities help elective procedures rebound more quickly, as hospitals in hotspots still restrict non-urgent care.

By Maria Rachal • July 8, 2020

As LabCorp, Quest feel COVID-19 strain, Trump admin pegs hopes on POC tests

Brett Giroir, the administration's lead for coronavirus diagnostics, said the goal is for rapid point-of-care tests from Abbott, BD and Quidel, performed outside of lab settings, to alleviate commercial testing capacity constraints.     

By Greg Slabodkin • July 8, 2020

Digital health funding defies expected pandemic-era slowdown

As COVID-19 roiled economies in the first half of 2020, investors poured $5.4 billion into digital health startups, the largest investment in the sector for the period over the past decade, per a midyear report from Rock Health.

By Susan Kelly • July 7, 2020

FDA warns of false positives with BD coronavirus diagnostic

On the heels of greenlighting BD's antigen test, FDA flagged an issue with its molecular test offering, telling healthcare professionals to treat positive results as “presumptive” and consider confirming findings via a different test.

By Nick Paul Taylor • July 7, 2020

Hospital traffic stalls as COVID-19 cases surge, analysts say

Some major chains saw volume dropping in the week ended June 28. HCA and Tenet saw 5.9% and 5.4% declines week over week when zeroing in on Texas, according to cell tower data tracked by Jefferies. 

By Samantha Liss • July 6, 2020

Endologix files for Ch. 11 bankruptcy, plans to go private

The endovascular stent graft maker received FDA approval earlier this year for its newest abdominal aortic aneurysm technology, but has faced disruptions amid a high-risk recall and delays to elective procedures from COVID-19.

By Maria Rachal • July 6, 2020

BD launches coronavirus antigen test, 2nd to get FDA emergency use authorization

The rapid, point-of-care diagnostic joins Quidel's, which had been the only option in the category for nearly two months. Still, FDA notes antigen tests are more likely than molecular diagnostics to miss active coronavirus infections.

By Greg Slabodkin • July 6, 2020

CDC gets FDA nod for coronavirus-flu combination diagnostic

The emergency use authorization comes months after BioFire and Qiagen got backing for similar tests and as the coming flu season adds a new complexity to diagnosis.

By Nick Paul Taylor • July 6, 2020

BARDA backs push for clinical-grade wearable to detect signs of COVID-19

As companies like Fitbit aim to leverage their wrist-worn devices to monitor for disease symptoms, developers at Northwestern University argue that consumer tech falls short compared to clinical-grade, chest and neck-worn wearables.

By Nick Paul Taylor • July 2, 2020

Kroger wins EUA for at-home coronavirus test kit

The grocer will make the home-collection kits available to employees this week and, along with partner Gravity Diagnostics, plans to process up to 60,000 tests weekly by the end of July.

By Jeff Wells • July 1, 2020

Notified body poll finds multi-month waits for COVID-19 conformity assessments

More than half surveyed by the European Commission expect to spend six months to a year processing applications for certain devices addressing coronavirus.

By Nick Paul Taylor • July 1, 2020