Visby Medical™ announced that it has received 510(k) clearance and was granted a CLIA waiver from the U.S. Food and Drug Administration for its second generation point of care (POC) test. The Visby Medical Sexual Health test is a fast, polymerase chain reaction (PCR) diagnostic test for the detection of sexually transmitted infections (STIs) caused by Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis in women.
DISC Surgery Center at Newport Beach ("DISC") has deepened its partnership with Blue Shield of California ("Blue Shield") to both advance and increase access to leading-edge spine care in the outpatient setting.Announcement is the result of a thoughtful and swift negotiation. DISC, through parent company TriasMD, was one of the first surgery centers in California to work directly with Blue Shield in 2023 to establish a new and expansive contract.
PENTAX Medical Americas, a division of HOYA Group, is excited to announce that it has obtained CE marks, clearing it for commercialization in the European Union for two of its latest innovations: the PENTAX Medical INSPIRA™ premium video processor and the i20c video endoscope series.
Children's Minnesota is thrilled to announce it is the first health system in North America to open a pediatric hybrid intraoperative magnetic resonance imaging (iMRI) suite equipped with both moving-scanner and moving-patient MRI technology in the same surgical space.
Co-Diagnostics, Inc.a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced that it has commenced clinical evaluations for its at-home and point-of-care Co-Dx PCR
Hologic Inc. (Nasdaq: HOLX), a global leader in women's health, has announced approval of the NovaSure® V5 global endometrial ablation (GEA) device in Canada and Europe.
Tasso, Inc., the leading provider of patient-centric, clinical-grade blood collection solutions, announced that the TassoOne™ Plus, a new high-volume liquid blood collection device, has received CE Mark certification and successfully fulfilled all of the performance,safety, and relevant product requirements.
Cardiawave SA, a deeptech medical device manufacturer that has developed Valvosoft®, an innovative non-invasive medical device to treat aortic stenosis, the most prevalent heart valve disease in adults, announces the issuance of 3 new patents in the United States.
LivaNova announces limited commercial release of Essenz Perfusion System for cardiopulmonary bypass procedures in select European centers. The system includes a next-gen heart-lung machine and a patient monitor that provides data-driven decisions during life-saving CPB procedures.
BD,a leading global medical technology company, had announced that it has received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) for a new molecular diagnostic combination test for SARS-CoV-2, Influenza A + B and Respiratory Syncytial Virus (RSV) to help combat illness in the current and future respiratory virus seasons.