The Latest
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Tandem reports 224 injuries related to faulty insulin pump app
A problem with Tandem’s iPhone app could drain the battery of the connected insulin pump, causing it to power down sooner than expected.
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FDA tells providers to stop using Getinge heart devices
After months of safety concerns, the FDA said Getinge has yet to “sufficiently” address the problems and risks.
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Samsung Medison to buy AI ultrasound company Sonio
Sonio’s software uses deep learning to improve image quality. Its software will remain compatible with all ultrasound machines, the company said.
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Geneoscopy wins FDA approval for Labcorp-partnered colon cancer test
Evercore and Cowen analysts expect Colosense to have a limited impact on Exact Sciences’ rival Cologuard test.
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Integra still addressing problems at Boston plant
A third-party audit of the Boston facility identified more issues, forcing Integra to keep Surgimend and Primatrix off the market for the foreseeable future.
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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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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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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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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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Deep Dive
EtO 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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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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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 -
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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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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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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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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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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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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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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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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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.