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While Bridgefield will serve as the division's new owner, its products will continue to carry the Philips name, through an international licensing deal set to span up to 15 years. [ABSTRACT FROM AUTHOR]

The new 510(k) clearance expands the portfolio of the company's Zoom aspiration system to add the Zoom 88, with its 0.088 inch-wide opening. [ABSTRACT FROM AUTHOR]

The FDA has tapped Sara Brenner to serve as acting commissioner as it awaits new leadership from the Trump administration to complete the congressional confirmation process. [ABSTRACT FROM AUTHOR]

The author of the seminal cancer biography The Emperor Of All Maladies and the co-founder of LinkedIn are looking to develop new medicines. [ABSTRACT FROM AUTHOR]

Intuitive said the limited rollout of its da Vinci 5 system has so far shown strong adoption and contributed to a rise in worldwide procedures. [ABSTRACT FROM AUTHOR]

The cobas liat system received a new FDA clearance, as well as a waiver from mandates requiring that certain clinical tests be analyzed within a lab. [ABSTRACT FROM AUTHOR]

The medtech has tapped Katie Szyman for the role, who served as head of Edwards' critical care business, which was sold last year to BD. [ABSTRACT FROM AUTHOR]

The company is set to begin trading on the Nasdaq between $14 and $16 per share—a range that would give Beta Bionics about a $625 million valuation. [ABSTRACT FROM AUTHOR]

The company's medical device division alone grew 13.4% during the past 12 months, when accounting for foreign currency exchanges, to log $18.99 billion in revenue. [ABSTRACT FROM AUTHOR]

Among his first actions as president, Trump rescinded an order that directed the U.S. government to develop safeguards for AI programs. [ABSTRACT FROM AUTHOR]

With results in about 30 minutes, the benchtop TriVerity test is designed to help emergency department clinicians determine whether a patient is fighting off a bacterial or viral infection, and to see if they may be at risk for developing sepsis. [ABSTRACT FROM AUTHOR]

The deal includes facilities in Atlanta, Georgia and St. Paul, Minnesota; the financial details were not disclosed. [ABSTRACT FROM AUTHOR]

Shortages of appropriate devices may force clinicians to adapt with equipment for adults, adding increased risk, said CDRH Director Michelle Tarver. [ABSTRACT FROM AUTHOR]

The project will launch a Care Innovation Hub within UCSF's Department of Radiology & Biomedical Imaging, bringing together the university's oncology and brain research and GE HealthCare's product development efforts. [ABSTRACT FROM AUTHOR]

According to Philips and the FDA, some cardiac events recorded by electrocardiogram were not correctly flagged and routed to clinicians for review. [ABSTRACT FROM AUTHOR]

The blood sugar tracking company offered a preliminary look at its annual and fourth quarter earnings report at the J.P. Morgan Healthcare Conference in San Francisco. [ABSTRACT FROM AUTHOR]

Illumina and Regeneron are taking stakes in health data company Truveta to help fund research that may dwarf previous DNA sequencing projects. [ABSTRACT FROM AUTHOR]

The CE mark allows the company to begin rolling out the treatment immediately, essentially as a software update, to both new and existing patients. [ABSTRACT FROM AUTHOR]

In an early look at its 2024 earnings, Guardant's $737 million total topped not only Wall Street estimates, but its own financial forecast. [ABSTRACT FROM AUTHOR]

Johnson & Johnson MedTech announced that it has paused U.S. procedures and sales of its recently approved Varipulse pulsed field ablation system following reports of four patient strokes. [ABSTRACT FROM AUTHOR]

The series C round was co-led by Arboretum Ventures and Solas BioVentures, and joined by backers at Orlando Health Ventures, Coloplast and Tonkawa. [ABSTRACT FROM AUTHOR]

Set to close within the first half of the year, the deal could see Boston Scientific compete in the future against systems from Abbott, Philips and J&J, among others. [ABSTRACT FROM AUTHOR]

Stryker said the addition of Inari's devices for venous thromboembolism will complement its current neurovascular business. [ABSTRACT FROM AUTHOR]

The FDA also handed down a breakthrough designation to FIRE1's Norm system, with a minimally invasive sensor to help monitor for unsafe fluid buildup. [ABSTRACT FROM AUTHOR]

The FDA has published a set of long-awaited recommendations to the industry to help ensure pulse oximeters work correctly across all skin tones. [ABSTRACT FROM AUTHOR]

An independent literature review searched for contaminants in tampons, including metals, phthalates, parabens and volatile organic compounds. [ABSTRACT FROM AUTHOR]

This year may bring major changes in how artificial intelligence shapes the healthcare industry—and vice versa—and tempering hype for the technology with ensuring patient safety will be essential. [ABSTRACT FROM AUTHOR]

Abbott and Dexcom have agreed to settle all of their remaining international legal disputes over patents related to their continuous glucose monitors for people with diabetes. [ABSTRACT FROM AUTHOR]

Humacyte's tissue-based Symvess is designed to be universally implantable, to help rapidly reconnect the vascular system when a patient is facing the loss of a limb. [ABSTRACT FROM AUTHOR]

The deal, valued at about $9 million in cash to start, will see NeuroMetrix become an electroCore subsidiary. [ABSTRACT FROM AUTHOR]

The effort focuses on updating instructions for the POLARx system, after reports of damage to the esophagus, including seven injuries and four deaths. [ABSTRACT FROM AUTHOR]

Developed by neurosurgeons at the University of Calgary, the hybrid polymer-metal ReSolv stent slows the flow of blood to form a clot within the aneurysm. [ABSTRACT FROM AUTHOR]

Boston Scientific said it has seen two reported patient deaths linked to the issue. [ABSTRACT FROM AUTHOR]

Pleno plans to launch its Raptor benchtop analyzer early next year, and it's poached Illumina's Vik Vaz to lead its commercialization. [ABSTRACT FROM AUTHOR]

The agency expanded its previous approvals for the Impella 5.5 and CP pumps for children weighing at least 30 kg and 52 kg, respectively. [ABSTRACT FROM AUTHOR]

The U.S. Preventive Services Task Force updated its guidelines for cervical cancer screening, endorsing HPV testing over Pap smears for certain women. [ABSTRACT FROM AUTHOR]

With a focus on treating mitral and tricuspid valve disease, Capstan's robotic approach handles the final steps of guided implant placement and deployment. [ABSTRACT FROM AUTHOR]

AngioDynamics obtained a green light for its NanoKnife prostate cancer ablation system, designed to target tissue without delivering excess heat. [ABSTRACT FROM AUTHOR]

Artivion has secured a green light from the FDA for its stentlike implant designed to help remodel the interior of the aortic arch following rare and severe tears within the lining of the major blood vessel. [ABSTRACT FROM AUTHOR]

After securing Medicare coverage this year for its kIQ wearable neurostimulator, Cala raised $50 million to boost its commercial trajectory. [ABSTRACT FROM AUTHOR]

Donald Trump has named tech investor David Sacks to be "A.I. & Crypto Czar" as a newly created role in his administration next year, to help guide its approaches toward artificial intelligence. [ABSTRACT FROM AUTHOR]

Working with real-world cancer data company COTA, the former Fierce 15 winner put up its PreciseBreast test against Exact Sciences' Oncotype DX. [ABSTRACT FROM AUTHOR]

A federal jury has sided with Insulet over claims that the South Korea-based EOFlow had stolen trade secrets related to its wearable insulin pump, in a case that complicated Medtronic's acquisition plans late last year. [ABSTRACT FROM AUTHOR]

Led by Insight Partners and joined by Battery Ventures, the nine-figure total adds to Cleerly's $223 million series C round from mid-2022. [ABSTRACT FROM AUTHOR]