Tag: FDA

CMS proposal to end inpatient only list draws strong industry response

Editor's Note The plan to eliminate the Medicare Inpatient-Only (IPO) List and expand the Ambulatory Surgery Center Covered Procedures List (ASC-CPL) from the Centers for Medicare & Medicaid Services (CMS) has generated widespread reaction, with more than 3,900 comments submitted during the official feedback period, Ambulatory Surgery Center News September…

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By: Tarsilla Moura
September 22, 2025
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FDA flags device recalls while clearing new technologies for surgery, critical care

Editor's Note The Food and Drug Administration (FDA) has issued multiple high-risk medical device recalls in recent weeks, mid-September FDA announcements report. On August 21, Medline alerted customers that some of its convenience kits contain recalled Medtronic DLP Left Heart Vent Catheters. These catheters, used in cardiopulmonary bypass, may fail…

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By: Tarsilla Moura
September 16, 2025
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Drug that makes tumors glow is transforming cancer surgery

Editor's Note A new drug is giving surgeons a sharper view of cancer in the OR and helping preserve healthy tissue, Fast Company August 28 reports. Cytalux is an FDA-approved fluorescent agent that makes cancer cells glow green under infrared light, allowing surgeons to spot and remove malignant lesions with…

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By: Tarsilla Moura
September 2, 2025
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Surgical robotics market accelerates as new players challenge industry giants

Editor's Note Dozens of companies are racing to stake a claim in the rapidly expanding surgical robotics market, with multiple launches, partnerships, and regulatory milestones signaling a pivotal moment for the field. Challengers to established leaders are advancing soft tissue systems, targeting specialty niches, and building executive teams to scale…

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By: Tarsilla Moura
August 28, 2025
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FDA issues early alerts on multiple high-risk device recalls from J&J, Medtronic, Baxter, Boston Scientific

Editor's Note The Food and Drug Administration (FDA) has issued a series of early alerts this month regarding high-risk recalls from several leading medical device makers, citing patient safety risks ranging from pump failures to vascular complications. These alerts highlight issues with products from Johnson & Johnson’s (J&J’s) Abiomed unit,…

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By: Tarsilla Moura
August 28, 2025
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Robots reshape surgical services, part 1: Emerging tech, rising risks

Takeaways • Robot-assisted surgery (RAS) is now an option in many specialties and for adult and pediatric patients; RAS-related ethical issues include access and patient privacy. • Intuitive Surgical continues to dominate the marketplace, but many companies are working on expanding their range of options. • Some current trends and…

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By: Cynthia Saver
August 27, 2025
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UC Davis secures $2M to study bone health in prostate cancer, prevent post-injury arthritis

Editor's Note The UC Davis Department of Orthopaedic Surgery has received more than $2.2 million in Department of Defense funding for two research projects addressing bone health in prostate cancer and preventing arthritis after joint injuries, a UC Davis Health July 15 news release reports. The larger grant, $1.8 million,…

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By: Tarsilla Moura
August 20, 2025
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FDA: National IV saline shortage over after years of strained supply

Editor's Note The Food and Drug Administration (FDA) officially declared the nationwide shortage of sodium chloride 0.9% injection products over, saying a critical supply line for hospitals and surgical teams is restored. According to an August 8 statement from FDA Commissioner Martin A. Makary, MD, MPH, the resolution marks a…

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By: Tarsilla Moura
August 14, 2025
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FDA announces Class 1 recall for Draeger breathing filters

Editor's Note The FDA has issued a Class 1 recall—the most severe category indicating risk of serious injury or death—for Draeger Filter SafeStar 90 Plus (MP05785), Filter SafeStar 55 Plus (MP05790), Filter SafeStar 60A Plus (MP05795), and Filter/HME TwinStar HEPA Plus (MP05801) breathing system filters, affecting all lot numbers. Draeger…

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By: Matt Danford
August 13, 2025
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FDA orders opioid label changes to highlight long-term risks

Editor's Note The US Food and Drug Administration (FDA) is requiring safety labeling changes for all opioid pain medications to better emphasize and explain the risks associated with long-term use, according to a July 31 announcement. These changes follow a May advisory committee meeting where the agency reviewed data on…

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By: Matt Danford
August 6, 2025
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