FDA OKs Yale COVID-19 saliva test removing RNA extraction step

While the agency called the method potentially groundbreaking, one public health expert cautioned that the assay must be performed in highly specialized labs and is not considered a rapid test.

By Nick Paul Taylor • Aug. 17, 2020

HHS commits $6.5M to add Thermo Fisher, Beckman Coulter COVID-19 test supplies to Aegis, Sonic labs

The federal funding to scale testing, still dwarfed by government spending on vaccines, came the same week labs and providers urged the administration to update testing prioritization guidelines given limited resources.

By Greg Slabodkin • Aug. 14, 2020

Myriad names new CEO, reports sales sank 57% amid COVID-19 shutdowns

The beleaguered molecular diagnostic company had competitive weaknesses prior to the pandemic that remain unresolved. But SVB Leerink analysts contend Paul Diaz’s appointment could help it "turn the corner."

By Nick Paul Taylor • Aug. 14, 2020

Hospitals, docs pitch roadmap to keep essential surgeries going even with coronavirus surges

While many medtechs cast the worst of the pandemic's impact in the rearview mirror in recent financial reports, concerns from healthcare industry groups reflect a more nuanced picture. 

By Nick Paul Taylor • Aug. 14, 2020

Thermo Fisher-Qiagen deal falls apart after failing to secure shareholder support

Thermo Fisher recently raised its bid for Qiagen shares, taking into account the company's COVID-19 testing gains. But when the offer expired Monday, less than half of shares were tendered.

By Nick Paul Taylor , Maria Rachal , Greg Slabodkin • Updated Aug. 13, 2020

Inari Medical revenue rises in 1st quarterly report since public debut

Specializing in clot-removal devices for pulmonary embolism and deep vein thrombosis, the medtech's CEO downplayed new competition in the space, claiming that only 2% of the $3.6 billion market is penetrated.

By Susan Kelly • Aug. 12, 2020

Hologic jumps into COVID-19 pool testing, aimed at boosting lab capacity

LabCorp and Quest last month announced their own specimen pooling methods. Unlike Hologic, however, they have already been granted emergency use authorizations by FDA. 

By Nick Paul Taylor • Aug. 12, 2020

State coronavirus testing targets diverge, some plan declines by December

Monthly testing goals submitted to HHS show Connecticut and Illinois are among those looking to multiply monthly testing volumes, while Louisiana and Maine, for example, are projecting lower levels at the end of the year.

By Maria Rachal • Aug. 11, 2020

Guardant growth slows in Q2 but still beats expectations

The precision oncology company reported a 23% increase in sales, yet refrained from reinstating full-year guidance amid ongoing uncertainty about the impact of COVID-19. 

By Nick Paul Taylor • Aug. 7, 2020

BD sales slide below expectations, as COVID-19 antigen test gains momentum

In the month since the launch of its antigen test, CEO Tom Polen said BD shipped more Veritor readers than in a typical year. Still, the medtech's stock fell 9% Thursday amid pressure on other business lines.

By Greg Slabodkin • Aug. 6, 2020

ResMed beats Street with ventilators driving revenue up 9%, but tailwinds ebbing

"While we are still working on current and future contracts with hospitals, as well as city and national health authorities for these ventilators, the volumes will be significantly lower in the September quarter," said CEO Mick Farrell.

By Greg Slabodkin • Aug. 5, 2020

10 states now on board to buy Quidel, BD antigen tests

With the latest additions of Arkansas and Rhode Island, there are now five Democratic and five Republican governors each planning to acquire half a million of the rapid point-of-care diagnostics from the medtechs.

By Greg Slabodkin • Updated Aug. 19, 2020

Device maker Q2 reports show optimism on COVID-19 recovery, but flare-ups keep guidance at bay

Since March and April lows, business volume has improved sequentially. Still, many medtechs are tightlipped on what that may mean for financial performance for the rest of the year.

By Maria Rachal • Aug. 3, 2020

House panel asks IG to investigate Trump admin bungling of Philips ventilator deal

The Subcommittee on Economic and Consumer Policy on Thursday sent a letter to the acting inspector general requesting a probe into findings that HHS overpaid by $500 million in a contract negotiated with the Dutch medtech. 

By Susan Kelly • Updated Aug. 7, 2020

Quidel says COVID-19 antigen test buoys 270% rise in rapid diagnostics unit, demand 'more than we can satisfy'

The company late Thursday reported second quarter total sales of $201.8 million, an 86% increase over the prior year, with strong demand for its PCR and antigen tests for the coronavirus.

By Greg Slabodkin • Updated July 31, 2020

Hologic blows away earnings expectations on COVID-19 testing surge

The manufacturer said it has ramped production capacity to at least 1.5 million coronavirus tests a week, estimating it provided a quarter to a third of the test results delivered in the U.S. during the recent quarter.

By Susan Kelly • July 30, 2020

Teleflex reports rapid rebound in UroLift sales, driving Q2 beat

The medical device maker also disclosed an unspecified number of job cuts and a DOJ investigation during its earnings call Thursday.

By Nick Paul Taylor • July 30, 2020

Baxter takes $180M revenue hit in thick of COVID-19

While acute therapies saw over 40% growth during the quarter, sales in Baxter's advanced surgery, medication delivery and pharma businesses were hurt by lower rates of hospital admissions and elective surgeries.

By Greg Slabodkin • July 30, 2020

Dexcom nixes plan to begin G7 launch this year

After growing revenues 35% in Q2, the diabetes tech company is focused on building out manufacturing for its continuous glucose monitoring systems and re-emphasizing its direct-to-consumer advertising.

By Maria Rachal • July 29, 2020

Boston Scientific sees sharp US recovery in Q2, CEO says 'procedures can't be deferred forever'

Organic revenue was down 29% during the quarter but beat analyst estimates, thanks in part to new patients in the pipeline and procedures performed in outpatient settings.

By Maria Rachal • July 29, 2020

Coronavirus could fuel clinical lab M&A by stressing smaller hospital players

Consultancy Kaufman Hall predicts a ramp-up of deals throughout the year, as hospital-owned labs seek support amid the pandemic. That forecast meshes with comments from Quest's CEO last week.

By Nick Paul Taylor • July 29, 2020

Smith & Nephew falls short of expectations, citing COVID-19 headwinds

The medtech's sales slumped in the second quarter, causing first-half trading profit to miss analyst consensus by $53 million. Though CEO Roland Diggelmann called July a "good" month, he opted against sharing guidance.

By Nick Paul Taylor • July 29, 2020

Robot redux: Pandemic scrambles competitive timelines for Intuitive, J&J, Medtronic

Surgeons expect a gradual recovery of robot-assisted procedure volumes in the back half of the year, but the outlook for new robot system placements in hospitals is less optimistic due to freezes in capital equipment budgets.

By Susan Kelly • July 28, 2020

Hologic wins HHS-DOD contract to boost COVID-19 test supplies production

Some analysts peg Hologic's current share of the U.S. COVID-19 molecular testing market between 25% and 30% and predict the manufacturing expansion could create a $150 million windfall in quarterly revenue.  

By Susan Kelly • July 28, 2020

LabCorp says COVID-19 testing 'more than' offsets still-recovering base business

LabCorp's improving average turnaround time for reporting molecular diagnostic test results stands in contrast to Quest, which for most of July has reported average result wait times for non-priority patients of a week or more.

By Greg Slabodkin • July 28, 2020