The Latest
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Courtesy of Outset Medical
Outset Medical gets FDA nod for dialysis accessory months after halting sales
Outset paused shipments of its TabloCart with prefiltration last year after receiving a warning letter from the FDA.
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Courtesy of CMR Surgical
CMR Surgical names new CFO
Shlomi Cohen takes over the role as the surgical robotics company focuses on global expansion and competing with market leader Intuitive Surgical.
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Courtesy of Masimo
Masimo’s at-home baby monitor cleared for use without prescription
A proposed separation of Masimo’s consumer business, which is currently under consideration, would likely include the Stork monitoring system.
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Courtesy of Medtronic
Medtronic wins approval to sell renal denervation device in China
Medtronic expects sales in China of the Symplicity Spyral blood pressure treatment to “be modest in the short-term.”
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Permission granted by Nextbeam
Deep DiveEtO causes cancer. Device sterilizers are scrambling to find alternatives.
No one solution can match the scope and scale of ethylene oxide, but a “multi-pronged approach” can help reduce emissions, an FDA official said.
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Nuthawut Somsuk via Getty Images
Karius raises $100M to expand access to multi-pathogen blood test
Karius plans to use the funding to expand the test outside of the hospital setting and support research of the company’s DNA technology beyond infectious diseases.
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Courtesy of Hologic
Hologic to lay off 190 workers as it closes European facilities
Three months after announcing unspecified international facility closures, Hologic has disclosed the number of affected employees and estimated $12.2 million in severance costs.
Updated May 6, 2024 -
Justin Sullivan via Getty Images
FDA qualifies Apple Watch AFib feature for use in clinical trials
Officials will accept atrial fibrillation data collected by the wearable as a secondary endpoint in studies of cardiac ablation devices.
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Courtesy of QuidelOrtho
QuidelOrtho names ex-Abbott exec Brian Blaser as CEO
Blaser is coming out of retirement to take charge of QuidelOrtho, after the diagnostics company fired former CEO Doug Bryant in February.
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Courtesy of Cue Health Press Kit
Cue Health to cut 230 employees
Declining COVID-19 test sales have forced Cue to eliminate hundreds of jobs in multiple rounds of layoffs over the past several years.
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sanjeri via Getty Images
Lab test overhaul: FDA to regulate LDTs as medical devices
Stricter review of new tests developed by laboratories is coming, but some fear the changes will be expensive, time-consuming and discourage innovation.
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Ramberg via Getty Images
UK sets out position on regulating AI as a medical device
Some AI products that currently can be put on the market without conformity assessment will move to a higher risk class, requiring more scrutiny.
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Courtesy of Quest Diagnostics
Quest to ramp up AI capabilities with purchase of PathAI’s diagnostic lab
PathAI is selling its diagnostics assets, including a Tennessee laboratory, but will continue to support its biopharmaceutical customers.
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Retrieved from Food and Drug Administration.
Cardinal receives FDA warning letter over unapproved syringes
The agency has recently increased scrutiny of plastic syringes made in China because of safety concerns, including blocking imports from two Chinese manufacturers.
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N/A via Getty Images
Philips reaches major settlements related to respiratory devices recall
A judge recently finalized an economic claims settlement, and Philips said it reached an agreement on medical claims.
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Nastassia Samal via Getty Images
Medline to buy Ecolab’s surgical products for nearly $1B
The medical products supplier will acquire Ecolab’s sterile drapes and fluid temperature management systems.
