Monkeypox to be renamed by WHO; ‘mpox’ will phase in over next year

The name change comes amid an outpouring of “racist and stigmatizing” language, the organization said. 

By Peter Green • Nov. 28, 2022

Masimo’s pulse oximeter has no significant racial bias, study finds

The company said the result reflects its use of four additional signal processing engines that cut the impact of factors including skin pigmentation.

By Nick Paul Taylor • Nov. 28, 2022

Explore the 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

‘Tripledemic’ concerns spur FDA to issue emergency authorization for flu-COVID-19 combination test

Experts have warned “a viral hurricane is making landfall” as cases of RSV, influenza and COVID-19 rise simultaneously.

By Nick Paul Taylor • Nov. 23, 2022

AI-powered blood test detects liver cancer, opening opportunity to improve screening

Researchers claim the blood test can double the number of liver cancer cases detected and increase early cancer detection.

By Nick Paul Taylor • Nov. 22, 2022

Q3 Earnings Wrap: Bumpy time for medtech with inflation, FX, supply woes

Macroeconomic pressures were a persistent theme for the industry, with workforce reductions a part of the fallout for some companies.

By Susan Kelly • Nov. 21, 2022

Apple Watch app for monitoring Parkinson’s symptoms earns FDA clearance

The technology has been validated in a clinical trial, positioning h2o to create an app that enables real-time sharing of Parkinson’s symptom data.

By Nick Paul Taylor • Nov. 21, 2022

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

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

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