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BIOTECHNOLOGY

Medical Device News Magazine reports breaking biotechnology news including new biotech developments, pharmaceuticals and more.

BD CEO Tom Polen Addresses FDA 510(k) Clearance of BD Alaris™ Infusion System

“Now that we have FDA clearance, we are eager to return to full commercial operations with an enhanced and updated Alaris System that we believe is the most comprehensive and innovative infusion solution on the market. The updated Alaris System addresses all open recalls, with the latest hardware, a new version of software, and important cybersecurity updates. With this release, we’ve improved the fundamental capabilities and features of the Alaris System. This further embodies and demonstrates BD’s commitment to quality and developing smart, connected devices to support the safe and efficient care of patients.

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PathogenDx’s New Rapid, Single Test Detects Salmonella and 13 Serotypes in Poultry as Foodborne Illness Remains a Significant Threat to Public Health in the US

“Salmonella outbreaks are a huge issue facing poultry producers, particularly when you look at the astronomical risk and costs associated with an outbreak,” said PathogenDx Co-founder and CEO Milan Patel. “For every confirmed case of Salmonella, another 30 go undetected. In fact, the Centers for Disease Control and Prevention (“CDC”) estimates that each year one in six Americans – or 48 million people – get sick, 128,000 are hospitalized and 3,000 die of foodborne diseases.

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Grifols Meets Enrollment Target in Phase 3 Study of Two Dose Regimens of Prolastin®-C in Patients with Emphysema Due to Alpha-1-Antitrypsin Deficiency

“While alpha-1 patients currently benefit from recommended AAT augmentation therapy, we hope to show clinical evidence of benefit with the current approved dose and a greater impact by doubling the single dose to 120 mg/kg weekly,” said Sandra Camprubi, Grifols Senior Director Clinical Operations. “We look forward to providing topline data from this study in 2026 and evaluating the next regulatory steps to provide emphysema patients impactful treatment options for alpha-1.”

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