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Medical Device News Magazine, in addition to offering a comprehensive view of the latest medical device news and industry information, publishes news on topics such as artificial intelligence (AI), medical manufacturing, other services, and more.
ProKidney Announces Purchase of Manufacturing Facility in Greensboro, NC
“This purchase represents an important component of our strategic manufacturing buildout,” said Dr. Tim Bertram, Chief Executive Officer of ProKidney. “With a staged investment strategy based on the clinical trial success of REACT, potential regulatory approval, and ultimately commercial demand, if approved, we intend, along with our current Winston-Salem facility, to supply enough REACT to match initial commercial demand. Subject to the outcome of the proact 1 and proact 2 clinical trials, we are targeting a Biological Licensing Agreement submission for Food and Drug Administration approval of REACT in 2026.
Pearl Receives Industry-First EU-MDR Certification for Second Opinion AI Platform
Second Opinion uses computer vision and machine learning to assist dentists by automatically detecting a broad range of dental conditions in bitewing, periapical and panoramic radiographs of permanent teeth in patients 12 and older.
RaySearch Signs Agreement with B dot Medical for Development of Advanced Software Solutions for Proton Therapy
B dot Medical is a Japanese company dedicated to the development of an ultra-compact proton therapy system with a non-rotating gantry, which is focused on achieveing exceptional irradiation performance, including cutting-edge features such as high-speed scanning and respiratory-gated irradiation.
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Aptar Digital Health and Tasso Combine Capabilities to Facilitate Blood Sample Collection for Multiple Indications Including Chronic Conditions and Oncology
The Tasso blood collection devices will be available to patients included in Aptar Digital Health randomized-clinical trials and real-world studies, as well as to life science companies with whom Aptar Digital Health collaborates to develop digital health solutions, such as digital therapeutics, disease management platforms and digital PSPs.
BD Launches New Robotic System to Automate Clinical Flow Cytometry
The BD FACSDuet™ Premium Sample Preparation System leverages liquid-handling robotics to automate the entire sample preparation process, for both in vitro diagnostics (IVD) and user-defined tests, including cocktailing, washing and centrifuging – and then automatically transfers samples to the physically integrated BD FACSLyric™ Clinical Flow Cytometry System, without human interaction. By being integrated with the flow cytometer, the BD FACSDuet™ Premium System enables a "walkaway" workflow solution that requires fewer manual steps, fewer resources and less user hands-on time than previous solutions.
Topcon Healthcare Launches Customer Care Portal
The Customer Care Portal is available to Topcon Healthcare customers in the U.S., Canada, and Latin America, and can be accessed by visiting support.topconhealthcare.com and registering for a free account.
Wolters Kluwer Webinar Brings Together Nursing Leaders to Discuss New Technologies
“In the midst of rapid adoption of AI-based technologies globally, a range of concerns ranging from academic integrity to plagiarism to misinformation has heightened the awareness among educators surrounding a need for action,” said Vikram Savkar, Senior Vice President & General Manager, Medicine Segment, Health Learning, Research & Practice at Wolters Kluwer Health. “The academic landscape must examine the best ways to benefit from these technologies while understanding the risks that may come with the implementation.”
Fairtility Expands European Market Penetration with CHLOE EQ ™, as Clinics in Five Countries Embrace Breakthrough AI Technology in IVF
“We selected CHLOE EQ because of its ability to provide quantifiable biological data on embryo development, quality and viability. This transparency and interpretability set it apart from other AI-based decision support tools available,” said Shabana Sayed, Senior Embryologist and IVF Lab Manager at Klinikk Hausken, part of Medicover. “Our embryologists see this system as a companion that helps augment and standardize decision making. It speaks to them in a language they understand –human biology.”
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