Refine by
Drug Device Articles & Analysis
146 news found
STEMart, a US-based provider of comprehensive services for all phases of medical device development, announced the expansion of its service offerings to include the Bacterial Reverse Mutation Test (Ames) service. ...
BySTEMart
Watertown, MA - June 29, 2025 - Biopharma PEG, a leading innovator in high-quality polyethylene glycol (PEG) derivatives, today announced it has successfully obtained Drug Master File (DMF) approval from the U.S. Food and Drug Administration (FDA) for its self-developed HZ-PEG-HZ (1K) product. ...
Key Product Highlights: · PEG Derivatives o A vast inventory of over 3000 high-quality PEG derivatives. o Monodispersed PEG linkers and multi-arm PEGs. o Scalable production from R&D to GMP commercial levels. o Applications spanning ADCs, PROTACs, LNP drug delivery, medical devices, and more. · Pharmaceutical Intermediates o Comprehensive ...
These hydrogels are pivotal in medical devices, regenerative medicine, drug delivery systems, 3D cell culture, and wound healing." ...
Biomedical Polymers Biomedical polymers have and still continue to play an important role in how we support and treat patients with various diseases through their use in tissue and blood interacting medical devices and drug delivery systems. Electrofunctional Polymers Conducting electroactive polymers such as polypyrroles, polythiophenes and polyanilines are a ...
Clinical trial managers work on cutting-edge studies and contribute to developing drugs and devices. What can clinical trial managers do to hone their skills and be prepared for future opportunities? ...
Nasaldrugdeliveryblog.com opens lines of communication between drug delivery researchers, device manufacturers. The first blog to address issues related to nasal drug delivery formulation, research, delivery, and devices was launched by Kurve Technology, Inc., a leading developer of nasal drug delivery ...
-based provider of comprehensive services for all stages of medical device development, has recently introduced API Impurity Identification services for clients in the medical device, pharmaceutical product, and consumer product industries using a variety of techniques under standard guidance. ...
BySTEMart
Broomfield Colorado 6/16/2022. Aktiv Pharma Group (Aktiv) announced today the acceptance of its novel glass-free, film-based flexible primary drug container (PDC) technology for sterile injectables named ARCH, into the US Food and Drug Administration (FDA) Emerging Technology Program (ETP). The ETP is a collaborative effort which supports the FDA’s mission to facilitate modernization in ...
The award, stage-gated based on achievement of pre-determined milestones and deliverables, provides funding for Enalare to perform pre-clinical toxicology, human clinical studies, drug and device manufacturing, and regulatory file submission for a formulation of ENA-001 suitable for community use. ...
The jointly developed therapy features a micro-infusion device that tightly controls drug delivery to a region of the brain for patients with medically refractory epilepsy. ...
The application for approval to commence VISABL-VT was submitted to the Ethics Committee at the Leipzig Heart Centre (the lead clinical site) as well as the German Federal Institute for Drugs and Medical Devices (BfArM), the German Competent Authority. Both submissions took place on September 15th. ...
ByImricor
Empirical Spine, Inc., a company developing advanced solutions for the surgical treatment of spinal disorders, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) for its LimiFlex™ Paraspinous Tension Band. ...
The funds will be used to develop the drug powder formulation and the delivery device (DryNeb) as well as other pre-IND studies. ...
Called the COPA system, the proprietary, hand-held drug dispensing device is meant to provide at-home methadone administration as part of treatment for opioid use disorder (OUD). ...
CardioWise, Inc., is pleased to announce that Perry Johnson Registrars, Incorporated has audited the CardioWise Quality Management System (QMS) and determined CardioWise is in conformance with ISO 13485:2016. Perry Johnson Registrars Certificate C2022-02910 was issued July 16, 2022, and represents the first step in the process of obtaining a CE mark and Medical Device Registration for the ...
Schmid brings extensive operations and business development leadership experience in diabetes and drug delivery. As Vice President of Operations and Business Development at Insulet Corporation, he was instrumental in the development, manufacturing, and commercialization of wearable smart drug delivery pumps such as the Omnipod Diabetes Management System, the ...
DSR (Direct Sodium Removal) heart failure drug development: Completed enrollment in SAHARA I[i] with first-generation DSR product (“DSR 1.0”) – extending study with second-generation DSR product (“DSR 2.0”) to support US IND[ii] filing by year end Proof-of-concept delivered in diuretic-resistant heart failure patients with dramatic and durable improvements in ...
– July 12, 2022 – Ancora Heart, Inc., a company developing a novel device-based therapy to address heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch® Ventricular Restoration System. ...
Renowned for helping prevent migraine attacks, a new FDA clearance paves way for more Cefaly devices that can now stop a migraine in progress and prevent a future episode too. CEFALY Technology announces today the release of two new U.S. Food and Drug Administration (FDA)-cleared migraine treatment devices. Cefaly®, already the first ...
ByCEFALY