The FDA has released draft guidance for developers of AI-enabled medical devices, offering recommendations aimed at ensuring the safety and effectiveness of the devices.
Supply Chain
The FDA is alerting healthcare providers about a potential high-risk issue with certain Baxter Healthcare Solution Sets with Duo-Vent Spikes.
UPS is shifting its focus from traditional parcel delivery to building a robust healthcare logistics business in an effort to offset slowing revenue from its core package services, Bloomberg reported Jan. 6.
Port workers represented by the International Longshoremen's Association are threatening to strike on Jan. 15, as contract negotiations with the United States Maritime Alliance, or USMX, remain stalled over issues of automation and job protections.
The FDA has issued an early warning regarding Medline Fluid Delivery Sets, which may pose a significant health risk due to a potentially incorrect assembly, according to a Dec. 30 news release from the agency.
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McKesson Medical-Surgical will shut down its Rock Hill, S.C.-based distribution center in the spring, marking the end of its decade-long operation in the area, The Post and Courier reported Dec. 30.
Medline Industries confidentially filed a proposed initial public offering with the U.S. Securities and Exchange Commission.
Baxter has announced a significant milestone in its recovery efforts following Hurricane Helene, with eight of the 10 manufacturing lines at its North Cove site now restarted. This brings the site to approximately 85% of its pre-hurricane capacity.
In the healthcare supply chain, "resilience" has become a ubiquitous term. It emerged as a critical focus during the COVID-19 pandemic, when hospitals and health systems struggled to procure personal protective equipment, ventilators and medications.
Boston Scientific has issued a recall for its POLARx Cryoablation Balloon Catheters after four deaths and seven reported injuries linked to astrio-esophageal fistulas, a severe complication during atrial fibrillation ablation procedures.