AIDOC: Granted AI industry-first FDA clearance for triage of incidental pulmonary embolism
This is the company's 6th FDA clearance and further solidifies its leadership as the most comprehensive acute AI vendor in the market
This is the company's 6th FDA clearance and further solidifies its leadership as the most comprehensive acute AI vendor in the market
Comprehensive portfolio is the first of several planned plating releases for the distal extremities
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of ASP0367/MA-0211 ("ASP0367") as a potential treatment for primary mitochondrial myopathies (PMM).
Ezra's Prostate AI is the first to ever be cleared by the FDA for prostate and lesion segmentation using AI
Fresenius Medical Care North America Announces Next Generation Solution Bags to Support Continued Home Dialysis Expansion
Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the Company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), for OPD5 - a second drug candidate based on the proprietary Peptide Drug Conjugate platform (PDC).
Personalized digital surgery platform can simulate surgery and print 3D surgical splints and guides for the operating room
Alkermes plc (Nasdaq: ALKS) announced positive voting outcomes from the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the U.S. Food and Drug Administration (FDA).
First compound from pipeline of six early-stage oncology programs to advance into clinical development-
RLF-100™ therapy associated with a 9-fold increased probability of survival and recovery from respiratory failure in an open-label, prospective study
World's Simplest High Throughput RT-PCR Test for COVID-19 has the potential to increase testing capacity by millions per week
WAKIX is the first and only non-scheduled treatment approved for excessive daytime sleepiness or cataplexy in adult patients with narcolepsy
Ajinomoto Bio-Pharma Services ("Aji Bio-Pharma"), a leading provider of biopharmaceutical contract development and manufacturing services, is pleased to announce that the US FDA has approved the first commercial drug manufactured via Aji Bio-Pharma's proprietary AJIPHASE® production process.
Automated, dual antigen serological testing for SARS-CoV-2 IgG antibodies now EUA approved and ready to ship!
Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative hematology solutions to drive better patient outcomes, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its NexSys PCS® system with Persona™ technology.
BD FACSDuet™ Sample Preparation System, now available in the U.S., as the first fully automated sample-to-answer solution when integrated with the BD FACSLyric™ Flow Cytometer
2nd Investigational Gene Therapy in Clinic, Potential 3rd Therapy in PKU Franchise, 15+ Year Commitment to PKU Community
MCRA's CRO assisted Simplify Medical with the management of the clinical study, including leading data management, Clinical Events Committee (CEC), and monitoring support for the successful PMA approval.
The Access Interleukin-6 (IL-6) assay is designed to assist physicians in the identification of severe inflammatory response in COVID-19 patients
Announced engaging Saul Kaye the founder of iCAN (www.israel-cannabis.com) and CannaTech (www.canna-tech.co) to provide an independent review of PAOG's RespRx research for the treatment of Chronic Obstructive Pulmonary Disease (COPD), and to help prepare RexpRx for engaging with a contract research organization (CRO) to advance an investigational New Drug application (IND) with the Food and Drug Administration (FDA).