Diagnostics: Page 15
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Courtesy of LabCorp
Labcorp hires ex-Quintiles CEO to lead clinical development unit ahead of upcoming spinoff
Thomas Pike, who oversaw the transformational merger of Quintiles and IMS Health, will be in charge of a CRO for the first time since 2016.
By Nick Paul Taylor • Jan. 6, 2023 -
Lisa Maree Williams via Getty Images
AstraZeneca extends C2i pact to validate minimal residual disease solid tumor blood test
The technology could improve cancer treatment and support clinical trial recruitment and monitoring.
By Nick Paul Taylor • Jan. 6, 2023 -
Explore the Trendline➔
Sitthiphong via Getty Images
TrendlineMedical 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 -
Courtesy of Illumina
Illumina signs new $750M credit agreement after bumpy year
The fallout from Illumina’s takeover of Grail and macroeconomic challenges have weighed on the company’s share price, which has fallen about 45% in the past 12 months.
By Nick Paul Taylor • Jan. 5, 2023 -
iStock via Getty Images
Roche receives first European IVDR certificate for companion diagnostic
Receipt of the certificate clears Roche to sell a companion diagnostic for immune checkpoint inhibitors in the European Union.
By Nick Paul Taylor • Jan. 5, 2023 -
Peter S Green/MedTech Dive
GE HealthCare starts trading on Nasdaq as independent company
The company’s stock gained in morning trading after debuting at $56 per share.
By Elise Reuter • Jan. 4, 2023 -
Permission granted by Freenome
Q&AFreenome CEO Mike Nolan talks colorectal cancer test, clinical trials
The San Francisco-based company recently enrolled a clinical trial for its blood-based cancer test but faces competition in the market for minimally invasive cancer tests.
By Elise Reuter • Dec. 22, 2022 -
Brendan Hoffman via Getty Images
Diagnostic testing reform missing from Congress’ year-end spending bill
A provision that would have brought in-vitro diagnostic tests and lab-developed tests under one regulatory framework was not included in the omnibus spending bill.
By Elise Reuter • Dec. 21, 2022 -
Courtesy of Odin Vision
Olympus agrees to $80M takeover of artificial intelligence endoscopy startup Odin Vision
The acquisition gives Olympus control of cloud-based AI systems to help detect and characterize cancerous and precancerous tissues during colonoscopies and gastroscopies.
By Nick Paul Taylor • Dec. 21, 2022 -
Fujifilm agrees to buy Inspirata’s Dynamyx in challenge to Philips for digital pathology market
Fujifilm struck the deal after customers told it “digitizing pathology will be the most transformative thing they do for their practice.”
By Nick Paul Taylor • Dec. 21, 2022 -
Guardant Health
Pivotal data on Guardant’s colorectal cancer blood test raise doubts about commercial prospects
Guardant’s share price fell 27% after the release of the news, which raised questions about whether the test can drive sales growth.
By Nick Paul Taylor • Dec. 19, 2022 -
Christian Cantarelli via Getty Images
Pfizer to partner with Mayo Clinic spinoff on early cardiac amyloidosis detection
Anumana and Pfizer will build an algorithm using ECG data to identify patients who may be at risk of developing the serious heart condition.
By Elise Reuter • Dec. 16, 2022 -
Courtesy of Grail
Illumina defends Grail acquisition before FTC amid potential divestiture order in Europe
Acquiring Grail would let Illumina help bring cancer tests to market sooner, saving thousands of lives, the company argues.
By Elise Reuter • Dec. 15, 2022 -
Courtesy of SD Biosensor
SD Biosensor postpones closing of $1.53B Meridian acquisition to complete financing
SD Biosensor, a company known in the West for its work with Roche, struck the deal to buy Meridian in July to expand into the U.S. in vitro diagnostic market.
By Nick Paul Taylor • Dec. 14, 2022 -
Brendan Hoffman via Getty Images
Healthcare groups urge Congress to pass diagnostic testing reform before year’s end
After the VALID Act was dropped from an FDA funding package, healthcare groups are asking legislators to add it to a year-end funding bill.
By Elise Reuter • Dec. 13, 2022 -
Peter S Green/MedTech Dive
Q&A
Friday Q&A: GE Healthcare’s Arduini, Zodl talk about spinoff, M&A, margins, Jack Welch
The CEO and CFO of the company spoke with MedTech Dive just weeks before the healthcare business formally separates from General Electric.
By Peter Green • Dec. 9, 2022 -
Permission granted by Apple
Apple prevails in AliveCor patent dispute ahead of potential Watch import ban
Patent board ruled that all 30 claims are unpatentable because they are obvious in view of other patents.
By Nick Paul Taylor • Dec. 8, 2022 -
Phynart Studio/Getty via Getty Images
AI detects prediabetes in CGM data, opening up new use for device: study
By correctly identifying many patients with prediabetes or Type 2 diabetes, researchers say CGMs can be used to prevent the disease.
By Nick Paul Taylor • Dec. 6, 2022 -
Johnny Greig via Getty Images
The 10 biggest medtech stories of 2022
MedTech Dive reporting this year has explored how companies maintained momentum even amid supply shortages and rising inflation rates.
By MedTech Dive staff • Dec. 3, 2022 -
Drew Angerer via Getty Images
Google Health licenses breast cancer detection AI to iCAD
Applying Google’s AI to breast-cancer screening algorithms may alleviate a shortage of trained physicians and enable faster tumor treatment.
By Nick Paul Taylor • Nov. 29, 2022 -
Joe Raedle via Getty Images
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 -
Wavebreakmedia via Getty Images
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 -
Mario Tama via Getty Images
‘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 -
sorbetto via Getty Images
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 -
Adeline Kon/Healthcare Dive/MedTech Dive
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
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