Color targets supply, staffing bottlenecks with updated coronavirus test EUA

The population health technology company's test uses dry nasal swabs, eliminating the need for the viral transport media that's been in short supply and limited scaling by lab giants Quest and LabCorp.

By Nick Paul Taylor • July 28, 2020

Coronavirus testing hits a wall: Where do we go from here?

As LabCorp and Quest are backlogged in delivering molecular test results, some public health officials are calling for a shift in testing approach from slow and accurate to fast and good enough to meet demand.

By Greg Slabodkin • July 27, 2020

Medtech and COVID-19: 6 months into the public health emergency

MedTech Dive examines where the industry stands with testing and the future of those emergency use-authorized diagnostics, as well as how it's adapting to a rebound in elective surgeries and various supply chain challenges.

July 27, 2020

Medtechs reboot with patients, providers after elective surgeries bottom out

Recovery of procedures critical to device companies came quicker than many in the industry expected. Now, device makers are adapting as business volumes normalize and COVID-19 continues to spread.

By Maria Rachal • July 27, 2020

How COVID-19 is challenging and changing medtech supply chain management

Four experts share insights on the supply and demand hangups medtechs have been working through during the pandemic, and a few early takeaways the industry can carry forward.

By Maria Rachal • July 27, 2020

Diagnostics makers must plan for EUA products to have post-pandemic future

An extension to the public health emergency formalized a reprieve for emergency use authorizations, but manufacturers should act now if they want products to stay on the market when the crisis ends, compliance experts say.

By Greg Slabodkin • July 27, 2020

LabCorp COVID-19 test gets 1st FDA OK for asymptomatic screening

U.S. regulators simultaneously allowed the LabCorp test to be used in sample pooling, following the first such nod to a Quest Diagnostics test a week ago.

By Nick Paul Taylor • July 27, 2020

COVID-19 diagnostics emerging as prime investment target, SVB analysis shows

Companies with tech involved in the pandemic response raised $1.3 billion over the first half of the year, with developers of tests and R&D tools enjoying a 62% increase in investment.

By Nick Paul Taylor • July 24, 2020

Edwards aims for 5% TAVR sales growth in 2020 after seeing demand bounce back

Quarterly sales came in $25 million above the top end of the device maker's guidance, with 90% of its active sites having done TAVR procedures in May and June. Yet, there are concerns regarding a slowdown in new patient screenings.

By Nick Paul Taylor • July 24, 2020

HHS renews COVID-19 public health emergency

The extension supported by AdvaMed, the American Clinical Laboratory Association and American Hospital Association takes effect Saturday and opens the door for FDA to keep issuing emergency use authorizations.

By Shannon Muchmore • July 23, 2020

COVID-19 test demand backs 61% jump in Roche molecular diagnostic sales in 2020

"As far as the molecular diagnostics business is concerned, there is no doubt we will sell anything we can produce over the next half year,” Roche CEO Severin Schwan said on an earnings call with investors. 

By Nick Paul Taylor • July 23, 2020

Quest says COVID-19 hotspot spikes starting to hit routine testing recovery

In addition to soaring demand for coronavirus testing, the lab giant's Q2 was helped by gradual improvement in base testing volumes. But recent outbreaks have sent numbers down again in July.

By Greg Slabodkin • July 23, 2020

Boston Scientific to begin limited US launch of latest Watchman device

The medtech hopes the updated version of its high-growth stroke technology will help boost its interventional cardiology unit as elective procedures pick back up.

By Maria Rachal • July 22, 2020

Thermo Fisher rakes in $1.3B in coronavirus-related Q2 revenue

The company expects momentum to continue in the third quarter after posting springtime results showing a more than 70% jump in its diagnostic and healthcare end market sales fueled by soaring demand for COVID-19 testing.

By Nick Paul Taylor • July 22, 2020

AdvaMed launches COVID-19 test registry to address shortages

Created in partnership with Abbott, Roche, Siemens and others, the database is aimed at helping ensure sufficient testing supply by providing weekly state- and national-level updates on the number of tests shipped.

By Nick Paul Taylor • July 22, 2020

4 healthcare sticking points as Congress weighs next coronavirus relief bill

Senate Republicans may limit allocations for testing efforts, as labs struggle to keep up with demand and return results in a timely enough fashion to leverage contact tracing.

By Rebecca Pifer , Samantha Liss • July 21, 2020

NuVasive surprises analysts with sooner-than-expected spine surgery sales rebound

Preliminary second quarter results show sales were down 30% year over year but were about a third higher than average analyst expectations, adding to evidence of a faster-than-predicted COVID-19 recovery in the medtech sector.

By Nick Paul Taylor • July 21, 2020

FDA eases rules on viral transport media to boost availability for COVID-19 testing

In some cases, a dearth of key materials has constricted efforts to widen COVID-19 testing. Now, the agency is allowing commercial manufacturers to ship products without filing a 510(k) or meeting UDI requirements.

By Nick Paul Taylor • July 21, 2020

As pandemic rages on, hip and knee surgeons lay out elective procedure guidance

An international group of orthopaedic experts outlined recommended changes to hospital protocols to prevent transmission of COVID-19 when elective procedures resume.

By Susan Kelly • July 20, 2020

Quidel says its COVID-19 antigen test is now on par with PCR accuracy

Results suggest the product is more sensitive than a rival test sold by BD. Some analysts say that could help shore up concerns about the faster, point-of-care tests' accuracy. 

By Greg Slabodkin • July 20, 2020

Quest coronavirus test becomes 1st with FDA OK for sample pooling

The technique is "not a magic bullet," Quest's chief medical officer said, with demand for its COVID-19 services still overwhelming capacity. However, rival LabCorp said it has reduced its average turnaround time for results.

By Maria Rachal • July 20, 2020

Philips sees double-digit COVID-19 connected care bump amid Q2 sales dip

Headwinds won out this spring, dragging total sales down 6%. Still, management predicted the return of elective procedures will help tip the balance to growth for the rest of the year.

By Nick Paul Taylor • July 20, 2020

3 Quest COVID-19 assays get FDA OK for at-home collection via telehealth

The agency this week granted new emergency use authorizations to three tests, previously granted EUAs, so users can self-collect nasal swab samples while being observed by a healthcare provider remotely.

By Greg Slabodkin • July 17, 2020

Thermo Fisher ups Qiagen offer by 10% after investor backlash cites COVID-19 growth

The acquisition was announced weeks before the U.S. doubled down on its need for widespread coronavirus testing, which provided a big business opportunity for Qiagen that it capitalized on during the second quarter.

By Maria Rachal • July 16, 2020

J&J device sales fell by one-third in Q2, but June rebound drives better 2020 outlook

Device sales in some areas returned to around 90% of pre-pandemic levels by the end of the quarter, causing J&J to improve its 2020 worst-case scenario for the division by $1.75 billion.

By Nick Paul Taylor • July 16, 2020