Diagnostics: Page 13
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Retrieved from SD Biosensor / FDA on May 30, 2023
Recall of Roche partner’s COVID tests labeled as Class I
The at-home COVID tests, made by SD Biosensor and distributed by Roche, were recalled for bacterial contamination.
By Elise Reuter • Updated June 8, 2023 -
Courtesy of Grail
Illumina accused of ‘playing delay tactics’ to push back EU decision on divesting Grail: Financial Times
Delaying the decision to divest Grail could let Illumina sell the liquid biopsy business when the market is more favorable.
By Nick Paul Taylor • May 30, 2023 -
Permission granted by Abbott
Abbott’s remote heart failure monitoring system reduces hospitalizations in clinical trial
The study is the third randomized, controlled trial globally to link CardioMEMS to a significant health benefit.
By Nick Paul Taylor • May 26, 2023 -
Neilson Barnard via Getty Images
Illumina chair loses to Icahn pick as proxy battle ends
The decision to replace board Chair John Thompson could change the company’s course as it decides whether to divest liquid biopsy company Grail.
By Elise Reuter • Updated May 25, 2023 -
Stock via Getty Images
Slump in medtech VC activity continues as inflation keeps investors on the sidelines
Investors struck deals worth $1.8 billion over the first three months of the year, down from $3.0 billion across the start of 2022.
By Nick Paul Taylor • May 25, 2023 -
Courtesy of Acurable
Acurable prepares to challenge ResMed for sleep apnea diagnosis market
The company’s device records the sounds of the patient’s respiratory and cardiac functions and monitors blood oxygen levels to assess suspected obstructive sleep apnea.
By Nick Paul Taylor • May 25, 2023 -
Kevin Dietsch via Getty Images
Illumina, Icahn prepare for proxy showdown
Can Carl Icahn bend Illumina to his will? Shareholders will vote Thursday on removing the company’s CEO and chairman from the board and replacing them with nominees from the activist investor.
By Elise Reuter • May 24, 2023 -
Scott Olson via Getty Images
Abbott cuts 199 jobs amid dwindling demand for COVID tests
The staff reductions at Abbott’s Westbrook manufacturing plant come as the company forecasts decreasing demand for the tests in 2023.
By Elise Reuter • May 24, 2023 -
Justin Sullivan via Getty Images
PulseAI algorithm beats Apple Watch software at detecting atrial arrhythmias
In a head-to-head comparison with Apple’s pre-installed software for interpreting ECG data, Pulse AI’s algorithm was better at detecting atrial arrhythmias.
By Nick Paul Taylor • May 23, 2023 -
Retrieved from Istock.
Thermo Fisher gets FDA clearance for first blood test of severe preeclampsia risk
A study found the test is a better predictor of the risk of developing preeclampsia with severe features than standard clinical measures.
By Nick Paul Taylor • May 22, 2023 -
Courtesy of Abbott
Abbott gains edge over cardiac monitor rivals with FDA clearance of 6-year device
Rival devices sold by Biotronik, Boston Scientific and Medtronic have battery lives ranging from three to 4.5 years.
By Nick Paul Taylor • May 19, 2023 -
ArtemisDiana via Getty Images
Rapid AI adoption could cause medical errors, patient harm, WHO warns, urging oversight
Warning that caution is not being exercised with use of artificial intelligence in healthcare, the World Health Organization called for rigorous oversight of the new technology.
By Susan Kelly • May 17, 2023 -
Courtesy of Grail
Icahn bolstered by another proxy advisor in battle with Illumina
The DNA-sequencing company defended its board chair, John Thompson, and drew attention to a new disclosure that Icahn’s firm is being investigated by the U.S. attorney for the Southern District of New York.
By Susan Kelly • Updated May 15, 2023 -
Patrik Stollarz / Staff via Getty Images
Philips agrees to pay SEC more than $62M to settle China corruption charges
Resolving charges that employees, distributors and subsidiaries may have engaged in improper bidding in China lets Philips put the issue behind it without admitting guilt.
By Susan Kelly • May 12, 2023 -
Courtesy of GE HealthCare
GE HealthCare’s order book raises questions about sales-growth potential, analysts say
BTIG analysts found “lower order growth than what is assumed” and shared concern the medtech company may face challenges just four months after it was spun off from parent General Electric.
By Nick Paul Taylor • May 12, 2023 -
Neilson Barnard via Getty Images
Icahn wins proxy firm nod to oust CEO from Illumina board
The recommendation from Glass Lewis is a boost for Icahn’s plan to force change at the DNA sequencer, as he and Illumina’s management battle for proxies ahead of a shareholder vote on May 25.
By Elise Reuter • May 11, 2023 -
Stock via Getty Images
Google adds image analysis capabilities to generative AI model, enabling dialogues with doctors
The Med-PaLM 2 has the ability to review X-rays and mammograms, write reports about images and respond to follow-up questions from caregivers.
By Nick Paul Taylor • May 11, 2023 -
Thermo Fisher, Pfizer partner to boost NGS cancer testing outside U.S.
The agreement is expected to increase access to next-generation sequencing for patients in more than 30 countries.
By Susan Kelly • May 10, 2023 -
Courtesy of GuardantHealth
Guardant blood test detects 83% of colorectal cancer cases, but fewer in early stage
Analysts said the test is likely to meet the bar for FDA approval, but its flaws in detecting early-stage cancer weaken its chances against Exact Sciences’ stool-based test, Cologuard.
By Elise Reuter • May 10, 2023 -
Courtesy of Grail
Illumina defends its board, calls Icahn campaign ‘character assassination’
The activist investor’s plan shows a lack of understanding of the company and genomics industry, the maker of DNA sequencers said.
By Susan Kelly • May 8, 2023 -
Neilson Barnard via Getty Images
Icahn says his Illumina board candidates will ‘ask the tough questions’
The billionaire investor repeated his call for the ouster of CEO Francis deSouza in a new letter to fellow shareholders.
By Susan Kelly • May 5, 2023 -
iStock via Getty Images
Algorithm may help avoid 40% of kidney transplant rejection misdiagnoses: study
The decision-support system “could have important clinical implications for the management and treatment of transplant recipients,” researchers found.
By Nick Paul Taylor • May 5, 2023 -
Permission granted by Becton Dickinson
BD raises full-year forecasts again, expects Alaris infusion pump approval
The company said revenue increases in a number of its product lines were faster than market growth rates, suggesting it’s gaining share.
By Susan Kelly • May 4, 2023 -
Courtesy of Hologic
Hologic, after overcoming chip shortage, starts considering larger M&A deals
The breast health unit “emphatically returned to growth” because of improvements to the supply of semiconductors.
By Nick Paul Taylor • May 2, 2023 -
Carl Court via Getty Images
Great Britain proposes allowing CE marks until 2030 to minimize Brexit disruption
The extended timeline to create a new regulatory system in England, Scotland and Wales is intended to prevent medical device shortages.
By Nick Paul Taylor • May 1, 2023
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