Emmaus Life Sciences, Inc. (OTC: EMMA), a leader in sickle cell disease treatment, announced revised prescribing information for Endari® to better inform healthcare professionals and sickle cell disease patients.
Company provides physicians with first portfolio comprised of drug-eluting stent and drug-coated balloon for the treatment of patients with peripheral artery disease
The Research Center Pharmaceutical Engineering GmbH (RCPE), a global leader in pharmaceutical engineering sciences, has been awarded FDA funding for two projects commencing in the 4th quarter of 2020
IlluminOss Medical, a medical device company focused on minimally invasive orthopedic fracture repair, announced an expanded U.S. Food and Drug Administration (FDA 510k) clearance for its Photodynamic Bone Stabilization System.
This 7th FDA clearance further solidifies DiA's leadership in the ultrasound AI space.
First FDA-cleared thermoset bioresorbable synthetic polymer
The First Ever Solution to Enable Digitization and Analysis of Full Field Peripheral Blood Smears with Decision Support System (DSS) Tailored to Augment Hematology Diagnostics
Dr. David Berger of Wholistic Pediatrics & Family Care comments on FDA's actions concerning public input on COVID-19 vaccine
Comprehensive portfolio is the first of several planned plating releases for the distal extremities
Fresenius Medical Care North America Announces Next Generation Solution Bags to Support Continued Home Dialysis Expansion
Personalized digital surgery platform can simulate surgery and print 3D surgical splints and guides for the operating room
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!
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
GI Windows Medical Corp, a clinical-stage, privately-held medical device company pioneering new advancements in anastomosis technology announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the self-forming magnetic compression anastomosis device indicated for small bowel end to end anastomosis for ileostomy reversal or tissue resection.