Renata Medical’s Minima Growth Stent Gains FDA Approval for Aortic Coarctation and Pulmonary Artery Stenosis
Renata Medical has announced that the U.S. Food and Drug Administration (FDA) has approved its innovative Minima Growth Stent, designed specifically for neonates, infants, and young children. This unique stent is engineered to be re-expanded as the child grows, offering…
ASM Announces Retirement of Founder and CEO Trung Phan
Applied Statistics & Management Inc. (ASM), a top provider of medical staff credentialing and privileging solutions, has announced the retirement of its founder, President, and CEO, Trung Phan. Trung Phan will step down from his role on August 30, 2024,…
RebrAIn Secures Second FDA Clearance for Enhancing Targeting in Neurosurgery
RebrAIn, a leader in precision neuro-surgery platforms, has secured its second FDA 510(k) clearance for its OptimMRI software. The latest version includes a machine learning model designed to aid in targeting the infero-lateral part of the VIM for lesioning techniques…
Median Technologies’ eyonis™ LCS Lung Cancer Diagnostic Hits All Study Endpoints
Median Technologies (FR0011049824, ALMDT, PEA/PME scheme eligible) announced that its AI-powered diagnostic tool, eyonis™ LCS, met the primary and all secondary endpoints in the REALITY study, the first of two pivotal trials required for marketing approval in the U.S. and…
Kaneka Completes New Medical Device Plant in Hokkaido
Kaneka Corporation (Headquarters: Minato-ku, Tokyo; President: Kazuhiko Fujii) (TOKYO: 4118) has opened its Tomatoh Manufacturing Site in the Tomakomai Tobu Area of Hokkaido, marking its seventh domestic business location and the first new site in 54 years. An opening ceremony…
Alnylam Shares HELIOS-B Phase 3 Results on Vutrisiran for ATTR Amyloidosis at ESC Congress
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, has announced detailed results from the HELIOS-B Phase 3 study of vutrisiran, an investigational RNAi therapeutic for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM). The data were presented at…
Novotech Reaccredited as Employer of Choice for Gender Equality
Novotech, a global full-service clinical Contract Research Organization (CRO), is pleased to announce its renewal as a Workplace Gender Equality Agency (WGEA) Employer of Choice for Gender Equality (EOCGE) for 2024. This accolade highlights Novotech’s ongoing dedication to maintaining an…
Allurion Publishes Data Showing Continued Weight Loss After One Year on Its Program
Allurion Technologies, Inc. (NYSE: ALUR) has announced new study results showing an average weight reduction of 10.5% at four months, improving to 13.7% at one year with the Allurion Program. This data highlights that not only can weight loss be…
Azitra Doses First Patient in Phase 1b ATR-12 Trial for Netherton Syndrome
Azitra, Inc. (NYSE American: AZTR), a leader in precision dermatology, has begun dosing the first patient in its Phase 1b trial of ATR-12 for Netherton syndrome. The trial will involve around 12 adult patients receiving twice-daily treatment for 14 days.…
BostonGene Highlights AI Multiomics Platform and Immune Profiling Advances at World Biomarkers Summit
BostonGene, a leader in AI-driven molecular and immune profiling, will showcase its advanced technologies at the 14th World Clinical Biomarkers & CDx Summit 2024, held from September 3 – 6 in Boston. The summit gathers professionals to advance biomarker-driven clinical…
SDC Capture Transforms Clinical Trials with New BYOD ePRO Solution
Statistics & Data Corporation (SDC), a leader in life sciences biometrics and technology solutions, has introduced its innovative Bring Your Own Device (BYOD) electronic Patient Reported Outcomes (ePRO) solution. This new solution is set to revolutionize clinical trial processes. Statistics…
Modivcare and ACC Launch Caring Hearts Initiative in New Jersey
Modivcare Inc. (Nasdaq: MODV), a technology-driven healthcare services company, is teaming up with the American College of Cardiology (ACC) to launch the Caring Hearts Initiative in Camden County, New Jersey. This initiative, through Modivcare’s Higi service, aims to deliver crucial…