Diagnostics: Page 19
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Abbott blood test predicts death, unfavorable outcomes in traumatic brain injury patients, study finds
Abbott is pursuing FDA clearance for the breakthrough-designated TBI test to expand access to a diagnostic that predicted death and severe disability.
By Nick Paul Taylor • Aug. 12, 2022 -
As monkeypox cases increase, disease experts lament lack of testing access
“It’s the same problem that happened with COVID-19. This is exactly identical,” said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security in Baltimore.
By Elise Reuter • Aug. 10, 2022 -
Trendline
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 -
Roundup: Medical device industry confident it can ride out recession, wary of slowing capital sales
While companies may weather a recession, they still face challenges like hospital staffing shortages, supply chain disruption and inflation, RBC Capital Markets analysts wrote.
By Nick Paul Taylor • Updated Aug. 10, 2022 -
Senate passes $740B bill to lower healthcare costs after months of wrangling
While Republicans successfully challenged a planned $35 insulin price ceiling for patients on private insurance, the law still has implications for makers of diabetes devices.
By Nick Paul Taylor • Aug. 8, 2022 -
FDA’s breakthrough device designations poised for another record year
At the midpoint of the year, the FDA had granted 129 designations, suggesting it will break the previous full-year record of 206.
By Nick Paul Taylor • Aug. 8, 2022 -
QuidelOrtho reports 37.5% sales growth in first quarter since $6B merger
The testing firm is increasing sales after Quidel merged with Ortho, opening opportunities to cut costs and increase point-of-care and molecular diagnostics revenue.
By Nick Paul Taylor • Aug. 5, 2022 -
Biden administration declares monkeypox a public health emergency
Federal health officials said Thursday that U.S. monkeypox testing capacity is at about 80,000 tests per week, although only 10% of capacity is currently being used.
By Ricky Zipp • Aug. 4, 2022 -
BD’s base business growth in Q3 offset by drop in COVID-19 testing
The company reported a year-over-year drop of about $224 million in COVID-19 testing revenue compared to 2021, with the testing slowdown expected to continue.
By Ricky Zipp • Aug. 4, 2022 -
Siemens Healthineers stumbles as lockdowns, falling COVID-19 sales and rising costs hit business
Lockdowns in China caused a steep decline in equipment orders and a big setback to the firm’s core diagnostic business, even as the company expects to meet full year revenue targets.
By Nick Paul Taylor • Aug. 3, 2022 -
North American Diagnostics latest to recall COVID-19 tests, gets Class I label from FDA
The recall adds to a list of medtech firms that have been forced to withdraw illegally distributed COVID-19 tests, amid concerns they could yield false results.
By Ricky Zipp • Aug. 2, 2022 -
Illumina vows to fight EU efforts to block $8B Grail merger
Illumina acquired the liquid biopsy company in 2021, despite pending anti-competitiveness investigations on both sides of the Atlantic.
By Elise Reuter • Updated Aug. 2, 2022 -
FDA reauthorizes Meridian’s COVID-19 test after changes to enable omicron detection
The renewed emergency use authorization comes as SD Biosensor works to close its $1.53 billion takeover of Meridian.
By Nick Paul Taylor • Aug. 1, 2022 -
Core diagnostic growth offsets falling COVID-19 sales at Hologic, Thermo Fisher, Qiagen
Rising demand for core diagnostics offset better-than-feared declines in COVID-19 test sales, shedding light on the companies’ post-pandemic futures.
By Nick Paul Taylor • July 29, 2022 -
Labcorp lowers forecast after Q2 slowdown, will spin off drug development unit
A drop in COVID-19 testing contributed to the company’s second quarter decline, while its base business grew by 1.2% compared to last year.
By Ricky Zipp • July 28, 2022 -
MedTech Europe pushes for semiconductor prioritization as US moves to increase local supply
The trade group wants political action to stop patient harm from “a growing divergence” between semiconductor supply and demand.
By Nick Paul Taylor • July 27, 2022 -
Philips shares hit 10-year low as supply chain challenges weigh on revenue
Sleep apnea machine recall adds to woes as sales forecast is slashed for remainder of 2022.
By Elise Reuter • July 25, 2022 -
Johns Hopkins sepsis alert tool reduced patient deaths, studies find
Three prospective studies of a machine learning tool developed by a Johns Hopkins spinout found it led to earlier antibiotic treatment and reduced patient mortality.
By Elise Reuter • July 22, 2022 -
Q&A
Friday Q&A: Matthew Binnicker, Mayo Clinic's director of clinical virology, talks COVID-19, monkeypox testing
With cases of both viruses rising across the U.S., clinical laboratories are bringing in staff to ramp up monkeypox testing, even as demand falls for clinical diagnostics of COVID-19.
By Elise Reuter • July 22, 2022 -
Roche CEO Schwan, who guided company as cancer drug powerhouse, to step down next year
The drugmaker’s current diagnostics chief Thomas Schinecker will take over as CEO in March, while Schwan will seek election as chair of Roche’s board.
By Jonathan Gardner • July 21, 2022 -
Test makers urge House, Senate to include diagnostic reforms in user-fee bill
AdvaMedDx, Abbott and Roche are among companies asking lawmakers to address the “urgent public health issue.”
By Nick Paul Taylor • July 21, 2022 -
Quest Diagnostics raises 2022 revenue forecast amid continued demand for COVID testing
The company boosted its outlook for the diagnostics unit even as the division posted a 31% decline in revenue in the second quarter.
By Ricky Zipp • July 21, 2022 -
Abbott's Q2 sales boosted by COVID-19 testing; outlook for diagnostics demand remains uncertain
The company’s $2.3 billion in COVID-19 testing sales beat J.P. Morgan and Stifel analysts’ estimates by about $1 billion, while CEO Robert Ford cautioned that forecasting demand remains challenging.
By Ricky Zipp • July 20, 2022 -
Sonic Healthcare joins CDC's monkeypox testing push to further grow capacity
Providers can order the Sonic Healthcare test as they would any other service, opening another pathway to diagnose a virus that has now infected almost 2,000 people in the U.S.
By Nick Paul Taylor • July 19, 2022 -
Diagnostic sector faces a 'challenging set-up' amid economic slowdown: analysts
Goldman Sachs warned there will be “limited visibility over the course of the year,” adding that companies may need to focus more on demonstrating their paths to profitability.
By Nick Paul Taylor • July 19, 2022 -
Illumina fails to block EU antitrust review of $8B Grail merger
By siding with the European Commission, the General Court has cleared the EU to resume a review that could lead to it blocking the deal and fining Illumina.
By Nick Paul Taylor • July 18, 2022