Die US-amerikanische Arzneimittelbehörde FDA hat dem Medizintechnikunternehmen PROCEPT BioRobotics die Genehmigung erteilt, eine klinische Studie zur Behandlung von Prostatakrebs mit ihrem AquaBeam Robotic System durchzuführen[1]. Diese Entscheidung markiert einen wichtigen Schritt in der Entwicklung neuer Therapieoptionen für Prostatakrebspatienten. Innovative Technologie gegen eine häufige Krebsart Prostatakrebs ist die häufigste Krebserkrankung bei Männern in Deutschland. Jährlich werden etwa 65.000 Neuerkrankungen diagnostiziert[2]. Die Erkrankung geht vom Drüsengewebe der Prostata aus und verläuft in frühen Stadien oft symptomlos[2]. Risikofaktoren sind vor allem ein hohes Lebensalter und eine familiäre Vorbelastung[4]. Das AquaBeam Robotic System von PROCEPT BioRobotics verwendet eine Kombination aus Bildgebung, robotergestützter Steuerung und Wasserstrahlablation. Diese Technologie ermöglicht eine präzise und schonende Entfernung von Prostatagewebe. Hoffnung auf verbesserte Behandlungsmöglichkeiten Die nun genehmigte Studie soll die Wirksamkeit und Sicherheit des Systems bei der Behandlung von Prostatakrebs im Frühstadium untersuchen. Dr. Nikolai Aljuri, Gründer und CEO… 

The U.S. Food and Drug Administration (FDA) has announced a significant milestone in the field of artificial intelligence and machine learning (AI/ML) in healthcare. As of August 7, 2024, the agency has authorized a total of 950 AI/ML-enabled medical devices for use in the United States. This remarkable figure underscores the rapid advancement and adoption of AI technologies in the medical field. The FDA has been diligently tracking and evaluating these innovative devices, which span across various medical disciplines. To provide transparency and inform the public, the FDA has compiled a comprehensive list of these authorized AI/ML-enabled devices. This list, which is regularly updated, includes detailed information such as the device name, manufacturer, date of approval, and its primary intended use. The FDA emphasizes that all listed devices have undergone rigorous evaluation to ensure they meet the agency’s stringent safety… 

On October 3, 2024, Baxter provided an update on the impact of Hurricane Helene on their North Cove manufacturing site in Western North Carolina[1]. The facility experienced significant damage due to unprecedented rain and storm surge, resulting in water permeating the site[1]. Baxter’s top priorities are supporting affected employees, restoring the facility, and ensuring continued supply to patients[1]. Site Status While progress has been made since the storm, Baxter does not yet have a specific timeline for resuming operations at North Cove[1]. The company is committed to restarting operations as quickly as possible, with CEO Joe Almeida pledging to spare no resource in this effort[1]. Key Areas of Focus Employees: Baxter has established contact with most of their 2,500+ colleagues but is still working to confirm the well-being of some employees due to cell phone access issues[1]. An employee assistance… 

iota Biosciences, Inc., a wholly-owned subsidiary of Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, „Astellas“) announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) for an Early Feasibility Study (EFS). The EFS will evaluate the safety and feasibility of an investigational implantable device designed to deliver electrical stimulation directly to the bladder wall, inducing contractions that facilitate bladder emptying in individuals impacted by underactive bladder (UAB). The FDA granted a staged approval of the EFS for this novel device. The first stage will include enrollment of three participants (at least one male and one female). Following successful safety outcomes from Stage 1, the FDA approved expanding the study to a total of 10 participants. UAB is characterized by a combination of lower urinary tract symptoms related to detrusor underactivity.…