Diagnostics: Page 16
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How wearable devices with skin-like stretchability may pave way for better health tracking
An AI-enabled prototype based on the stretchable technology was more than 95% effective at correctly identifying electrocardiogram signals.
By Nick Paul Taylor • Nov. 21, 2022 -
AEYE Health wins FDA clearance for AI-powered eye test to expand diabetic screening
Approval is a first step to letting primary care physicians use a hand-held camera backed by AI to diagnose potential diabetic-related sight issues.
By Nick Paul Taylor • Nov. 18, 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 -
Exact Sciences founders raise $56M for new liquid biopsy venture
The new firm, called Haystack Oncology, is looking to make a test that can detect residual cancer.
By Elise Reuter • Nov. 17, 2022 -
Roche gets EUA for high-throughput monkeypox test
The test targets two regions of the monkeypox genome, which were picked as they are less prone to mutations than other parts of the virus.
By Nick Paul Taylor • Nov. 17, 2022 -
How Labcorp, Abbott, BD, Siemens plan to expand home testing market
As demand wanes for COVID-19 testing, businesses see an opportunity in direct-to-consumer diagnostics.
By Elise Reuter • Nov. 16, 2022 -
Illumina cuts workforce by 5% amid supply chain woes, sales slowdown
The layoffs come as the firm wrestles with flat growth and a possible forced divestiture of its GRAIL cancer-detection unit.
By Nick Paul Taylor • Nov. 15, 2022 -
Mayo Clinic creates product to test AI models for bias and inaccuracy
The proliferation of AI models has led to concerns about whether they work as intended.
By Nick Paul Taylor • Nov. 14, 2022 -
Green light shows promise in addressing oximetry racial bias: study
Researchers created a noninvasive device that performed comparably to Abbott’s invasive i-STAT in a small clinical trial.
By Nick Paul Taylor • Nov. 14, 2022 -
Q&A
Friday Q&A: GE HealthCare’s Shetty on building accurate AI tools
The executive, who leads the company’s effort to create an integrated suite of AI tools for hospitals, warns against overloading clinicians with unconnected information.
By Elise Reuter • Nov. 11, 2022 -
Roche starts OTC sales of COVID-19 test in first push into US market
CVS, Amazon and the Optum Store are stocking the product, rebranded Pilot.
By Nick Paul Taylor • Nov. 11, 2022 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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