Tag Archives: FDA

The FDA recently approved a revolutionary device by Novocure, named Optune Lua, designed to treat non-small cell lung cancer through the creation of electric fields. These fields, according to the manufacturer, interfere with the division of malignant cells, offering a new avenue of treatment when combined with standard therapies such as immunotherapy or chemotherapy. This […]

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In its planning for the fiscal year 2025, the Food and Drug Administration (FDA) has announced an agenda resourced with several crucial topics related to medical devices. The agenda, released by the FDA’s Center for Devices and Radiological Health, prominently features guidance on laboratory developed tests (LDTs), artificial intelligence (AI), and cybersecurity. This dynamic focus […]

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In recent events, the Ascension health system endured a notable ransomware attack, bringing substantial disruption by shutting systems across several states. This induced operational hindrances like pharmacy closures and forced clinicians to revert to paper records. The incident underscored a growing concern: the increasing frequency of cyberattacks targeting healthcare facilities. These cybersecurity challenges were a […]

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The Food and Drug Administration (FDA) has classified the recall of Cue Health’s COVID-19 test kits as a Class II event, indicating that the products in question could cause temporary or medically reversible adverse health consequences, though the likelihood of serious health issues is considered remote. This classification follows a series of difficulties for Cue […]

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At the MedTech Conference in Toronto, discussions centered around the pivotal topic of artificial intelligence (AI) in medical devices, involving key regulators from the U.S. and Canada. The Food and Drug Administration (FDA) and Health Canada highlighted their ongoing and future regulatory strategies in view of the rapid integration of AI technologies in medical settings. […]

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In a recent paper published in the Journal of the American Medical Association (JAMA), key figures from the Food and Drug Administration (FDA), including Commissioner Robert Califf, delved into the complexities surrounding the regulation of Artificial Intelligence (AI) in healthcare. The paper highlighted not only the significant strides made in AI deployment but also the […]

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Onward Medical is focused on advancing neurostimulation technologies to significantly enhance the quality of life for individuals with paralysis, as highlighted by CEO Dave Marver during his discussion at the 2024 STAT Summit in Boston. The company, a Swiss-Dutch medical device innovator, is channeling its efforts towards pioneering devices, including a promising solution to manage […]

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Big data analysis plays a crucial role in the healthcare and life sciences fields, allowing for detailed insights into drug prescriptions, physician networks, and treatment trends. In an environment where data aggregation and analytics companies are proliferating, standing out is becoming increasingly challenging. Pharmaceutical companies, hospitals, payers, and others in the healthcare sector must differentiate […]

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Medtronic has recently secured approval from the Food and Drug Administration (FDA) to conduct an early feasibility trial for its advanced Affera mapping and ablation system combined with the Sphere-9 catheter. This trial is aimed at treating patients with sustained ventricular tachycardia (VT), a serious condition where the heart’s lower chambers beat unusually fast due […]

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Hologic, a notable player in the medical technology field, recently announced its acquisition of Gynesonics for $350 million, a strategic move to enhance its portfolio in gynecological treatments. Gynesonics is recognized for its innovative Sonata system, a non-invasive treatment option for uterine fibroids that utilizes ultrasound guidance and radiofrequency energy to effectively ablate fibroids without […]

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