Diagnostics: Page 18
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Phynart Studio/Getty via Getty Images
Medtech execs ‘rethink’ long-term strategies as care settings shift: Accenture report
The move from hospitals to ambulatory and at-home care is only just beginning, the survey found.
By Nick Paul Taylor • Nov. 10, 2022 -
Courtesy of Dr. Nada Ali/University of Washington
Affordable alternative: Smartphone-based hearing test for infants targets developing countries
The off-the-shelf alternative has a material cost of $10, giving children in impoverished regions easier access to vital monitoring and diagnosis.
By Nick Paul Taylor • Nov. 9, 2022 -
Retrieved from Siemsens Website on July 01, 2022
Siemens Healthineers beats sales forecasts on imaging demand as diagnostic pressures prompt restructuring
Siemens Healthineers is revamping its diagnostics unit after concluding that “external headwinds [are] outweighing operational improvements.”
By Nick Paul Taylor • Nov. 9, 2022 -
James Mutter via Getty Images
Quest broadens access to COVID-19 multiplex tests as flu cases rise
The new procedure is meant to encourage the use of tests that detect multiple respiratory viruses as the U.S. prepares for a challenging flu season.
By Elise Reuter • Nov. 3, 2022 -
Courtesy of Hologic
Hologic quarterly sales beat forecast even as demand for COVID tests wanes
The company expects its surgical and breast health businesses to rebound in fiscal 2023.
By Nick Paul Taylor • Nov. 1, 2022 -
Courtesy of Thermo Fisher Scientific
Thermo Fisher will buy The Binding Site for $2.6B to gain specialty diagnostics portfolio
The U.K.-based firm makes two blood tests for multiple myeloma.
By Elise Reuter • Oct. 31, 2022 -
Gorodenkoff/Stock.adobe.com
Brain surgery may get boost from new steerable catheter using minimally invasive robot
The steerable needle could help surgeons more accurately reach the deep, delicate parts of the brain than existing rigid catheter technologies.
By Nick Paul Taylor • Oct. 31, 2022 -
koto_feja via Getty Images
Researchers develop light-based sensor to overcome diagnostic limitations of electrodes
The technology could enable “ultra-miniature” interfaces for heart and nerve devices both in clinical diagnostics and laboratory research.
By Nick Paul Taylor • Oct. 31, 2022 -
Sarah Silbiger via Getty Images
FDA breakthrough device designations fall in Q3 but record year still within reach
If activity accelerates after the summer months, the agency will post another record year for designations.
By Nick Paul Taylor • Oct. 31, 2022 -
Courtesy of Labcorp
Labcorp lowers 2022 forecasts after Q3 profit falls on labor costs, declining COVID-19 revenue
To help reboot earnings, a planned spinoff of the Clinical Development business has been accelerated and the company will continue to acquire testing facilities from hospital systems across the country.
By Peter Green • Oct. 27, 2022 -
Courtesy of Thermo Fisher Scientific
Thermo Fisher raises full-year revenue forecast after posting extra $200M in COVID-19 test sales in Q3
With COVID test sales expected to fall to an “endemic run rate level” in the fourth quarter, the company expects growth to come from the pharma services and bioproduction units.
By Nick Paul Taylor • Oct. 27, 2022 -
GE HealthCare revenue rose 6% in Q3 as supply chain woes ease
The medtech company says global healthcare spending is solid, particularly in Europe and Asia.
By Elise Reuter • Oct. 25, 2022 -
Sarah Silbiger via Getty Images
Accelerate Diagnostics withdraws BD-partnered device after FDA demands 510(k) clearance
An analyst said they were “somewhat surprised” by the FDA’s decision as “Arc does not directly lead to a patient result.”
By Nick Paul Taylor • Oct. 25, 2022 -
Retrieved from Analytical Chemistry on October 21, 2022
Algorithm cuts disease biomarker analysis from hours to minutes in ‘leap forward’ for diagnosis
The new process could accelerate diagnosis, replacing existing tests that take hours or require multistep processes run on specialized equipment.
By Nick Paul Taylor • Oct. 21, 2022 -
adamkaz via Getty Images
FDA moves to make effect on health equity part of breakthrough device considerations
If it finalizes the proposal, the agency will expand its breakthrough program to devices that improve accessibility.
By Nick Paul Taylor • Oct. 21, 2022 -
Courtesy of Quest Diagnostics
Quest Diagnostics raises 2022 revenue forecast even as Q3 sales slump; shares climb
The diagnostics firm says a shift in emphasis away from COVID-19 testing is paying off.
By Peter Green • Oct. 20, 2022 -
Brendan Hoffman via Getty Images
Testing overhaul faces a ‘narrow pathway’ to pass before year end, industry groups say
Despite bipartisan support, a bill to allow the FDA to regulate lab-developed tests still faces hurdles to inclusion in an omnibus spending package.
By Elise Reuter • Oct. 20, 2022 -
Courtesy of Abbott
Abbott Q3 device sales slowed by supply chain pressures; COVID-19 tests exceed expectations
The company raised its earnings forecast for 2022 on the back of an expected $7.8 billion in annual sales related to COVID-19 testing.
By Elise Reuter • Oct. 19, 2022 -
Courtesy of Magnolia
BD forms co-promotion pact with Magnolia to reduce blood culture contamination
Magnolia’s blood collection device diverts the first 1.5 to 2 milliliters of blood samples that may be contaminated with flecks of skin, paving the way for more accurate diagnosis of sepsis.
By Nick Paul Taylor • Oct. 19, 2022 -
Sarah Silbiger via Getty Images
FDA seeks feedback on plans to draft and finalize medical device guidance in 2023
The agency’s review includes guidance on transitioning away from emergency use authorizations, while abandoning plans for guidance on software as a medical device.
By Nick Paul Taylor • Oct. 19, 2022 -
Joe Raedle / Staff via Getty Images
Avellino, Cepheid, GeneMatrix update COVID-19 test EUAs amid shift in FDA’s approach
COVID-19 test manufacturers have amended their fact sheets to state that diagnostics cleared or approved by the agency should be used instead of their emergency-authorized kits.
By Nick Paul Taylor • Oct. 17, 2022 -
Retrieved from Abbott/PRNewswire on June 15, 2020
Abbott, J&J and Intuitive to lead off medtech earnings season; procedures, supply chain in spotlight
Results from the three companies are expected to shed light on how the economic slowdown is affecting procedure trends in the industry.
By Nick Paul Taylor • Oct. 17, 2022 -
Permission granted by Becton Dickinson
Q&AFriday Q&A: BD’s Broache talks women’s health, at-home testing
Test adoption has increased as more customers have installed BD’s testing machines and the company hopes to offer more at-home assays in the U.S.
By Elise Reuter • Oct. 14, 2022 -
Vladimir Vladimirov/Getty Images via Getty Images
GE shores up contrast supply through deal with Chilean miner
A multiyear agreement with a Chilean mining company and the addition of a manufacturing line in Ireland will help GE insure against supply-chain disruptions.
By Elise Reuter • Oct. 13, 2022 -
GE advances healthcare spinoff plan, providing close look at workings of the unit
Localization requirements, third-party servicers, and more sophisticated data security threats are cited as risks to the healthcare unit.
By Nick Paul Taylor • Oct. 13, 2022
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