Der Grund für den Rückruf vom Februar 2024 ist, dass bestätigt wurde, dass das Siemens DCA HbA1c-Reagenzkit eine positive Abweichung anzeigt, ohne den Benutzer zu warnen. Die möglichen Auswirkungen des Defekts sind, dass fehlerhafte Testergebnisse gemeldet werden könnten und dies möglicherweise zu einer falschen Behandlung der Glukosekontrolle durch den Patienten führen könnte. Eine positive Abweichung kann bei elf betroffenen HbA1c-Chargen beobachtet werden. Eine positive Abweichung wurde beobachtet, als die Leistung dieser fünf HbA1c-Chargen mit NGSP-gepoolten Patientenproben mit zugewiesenem Zielwert verglichen wurde, und die maximale beobachtete Abweichung betrug 19 %. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=206139

Das Zentrum für Innovation und Digitalisierung (ZID) Bernapark und DragonLabz haben ein Förderprogramm für digitale Start-ups aufgelegt. In einem achtwöchigen Kurs sollen Talente bis zur Unternehmensbildung gebracht werden.     Das im Bernapark ansässige Zentrum für Innovation und Digitalisierung (ZID) und der Start-up-Förderer DragonLabz mit Sitz in Hergiswil haben ein Förderprogramm für Start-ups im Bereich der […] ZID Bernapark und DragonLabz fördern digitale Start-ups

Caves would protect earthlings from cosmic solar radiation. CAPE CANAVERAL. A team of scientists has confirmed that there is a cave on the moon, not far from where American astronauts Neil Armstrong and Buzz Aldrin landed 55 years ago, that could serve as a base for building permanently habitable bases. In an article published in… They found a cave on the moon that may be useful in building a base

Houston, Texas and Tuebingen, Germany, July 18, 2024 – Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today announced that the first proof-of-concept clinical data for its next-generation, half-life extended TCR Bispecific molecule, TCER® IMA401 (MAGEA4/8), will be presented during an oral presentation… Immatics Announces Upcoming Oral Presentation at ESMO Congress 2024

The Heme Foundation and Bioxytran join forces to address the global blood supply shortage The post Bioxytran Launches Joint Venture with the Heme Foundation for Development of Universal Oxygen Carrier appeared first on Bio Tech Winners. Bioxytran Launches Joint Venture with the Heme Foundation for Development of Universal Oxygen Carrier

Dies ist die Geschichte eines wissenschaftlichen Abenteuers. Aus dieser Sicht ist die Genetik ein „großzügiges“ Fach, in dem sich die Geschichten einzelner Menschen mit denen ihrer Familien, manchmal ganzer Länder oder geografischer Gebiete, verflechten. Und mit denen von Forschern und Ärzten, die zwischen Labors und Krankenhausstationen pendeln. Dramatische Geschichten, aber auch Geschichten von Hoffnung und… Brustkrebs, die Jolie-Mutation in Italien bereits vor 3000 Jahren

Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) („Acurx“ or the „Company“), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, today announced that a new patent has been granted by the United States Patent and Trademark Office (USPTO) on July 16, 2024. This patent relates to ibezapolstat and its use to treat C. difficile Infection (CDI) while reducing the recurrence of the infection, as well as improving the health of the gut microbiome. This is the latest in the series of granted patents and pending patent applications that Acrux has filed to protect its proprietary technologies in the field of antimicrobials.

InMode Ltd. (NASDAQ: INMD), a leading global provider of innovative medical technologies, is pleased to announce an additional FDA 510(k) clearance for the Morpheus8 technology. Morpheus8 is the first and only fractional radiofrequency (FRF) microneedling technology cleared for contraction of soft tissue. The U.S. Food and Drug Administration (FDA) has cleared the use of the Morpheus8 Applicators for the delivery of fractional radiofrequency use in dermatologic skin procedures where coagulation/contraction of soft tissue or hemostasis is needed. This FDA action expands Morpheus8’s existing FDA clearance, emphasizing the versatility of the technology for physicians and patients. Coinciding with this clearance is the launch of the new IgniteRF and OptimasMAX platforms, which include the Morpheus8 family of handpieces. The modular portfolio of tips, including Prime 12 pin, Morpheus8 24 pin, Resurfacing 24 pin, and Morpheus8 40 pin, makes this technology a versatile… 

Biotheryx, Inc., a biopharmaceutical company discovering and developing a portfolio of first-in-class protein degraders with a focus on validated targets in cancer and inflammatory diseases, today announced that the first patient has been dosed in its Phase 1 clinical trial evaluating BTX-9341, an investigational oral and bifunctional degrader of cyclin-dependent kinase 4 (CDK4) and cyclin-dependent kinase 6 (CDK6), as a monotherapy and in combination with fulvestrant for patients with advanced and/or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer who have previously received CDK4/6 inhibitor therapy either in the adjuvant or metastatic setting.

Full analysis of first-in-class CNS-101 study measuring functional neurophysiology at home in patients living with mild Alzheimer’s dementiaPoster presentations scheduled for the Technology and Dementia Preconference on Saturday, July 27th at 8:00 A.M. EST and main Alzheimer’s Association International Conference (AAIC) Annual Meeting on Tuesday, July 30th at 8:00 A.M. EST in Philadelphia, Pennsylvania