Leo Pharma and Portal Instruments this week announced a global collaboration and license agreement to develop a needle-free drug delivery system. Through the agreement, Leo Pharma’s investigational and approved medicines will be used in combination with Portal’s needle-free drug delivery system. Portal’s needle-free jet injector platform allows patients to self-administer biologics without needles. It features […]
Senseonics launches Eversense CGM System with non-adjunctive claim
Senseonics (NYSE:SENS) this week said it launched its Eversense continuous glucose monitoring system with its mobile app that can dose based on the system’s readings. The Eversense System is a long-term, implantable CGM sensor that features a transmitter that sends discreet vibrations to alert users of low and high glucose levels. The system with the CGM […]
How human factors created a new generation of drug delivery devices
Human factor testing is beneficial early on in the design process, rather than as a confirmation at the end. Here’s how testing for usability and desirability helped spark three generations of drug delivery devices. West Pharmaceutical Services has multiple generations of its SmartDose products under its belt since it started working on the drug delivery […]
Glaukos completes Avedro buy
Glaukos (NYSE:GKOS) today said it completed its acquisition of Avedro for an undisclosed amount. Avedro develops single-use drug formulations that are designed to strengthen corneal tissues and stop the progression of degenerative corneal ectatic disease keratoconus. “Today marks an important day for Glaukos as Avedro will serve as the cornerstone of our new corneal health franchise,” […]
Owlstone Medical partners with Thermo Fisher Scientific for breath biopsies
Owlstone Medical last week announced that it has forged a partnership with Thermo Fisher Scientific‘s (NYSE:TMO) to advance non-invasive breath sampling in disease detection. Through the agreement, both companies will integrate the Thermo Scientific Q Exactive GC Hybrid Quadrupole-Orbitrap MassSpectrometer into Owlstone Medical’s Breath Biopsy platform. The collaboration will hopefully qualify the mass analyzer for […]
Eitan Group launches preventative maintenance servicing tool for Sapphire infusion pumps
The Eitan Group last week said it launched a new preventative maintenance servicing tool to cut maintenance costs and runtime on its Sapphire infusion pumps. The new FasTestPM (preventative maintenance) replaces Eitan Group subsidiary Q Core’s previous maintenance kit and will allow users to quickly perform full maintenance tests on their Sapphire infusion pumps. Applicable […]
Indian CDSCO announces medical device, IVD regulatory updates
By Stewart Eisenhart, Emergo Group India’s Central Drugs Standard Control Organization (CDSCO) has rolled out several changes to its regulatory process for medical devices and in-vitro diagnostic products. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those […]
EU regulators clarify Notified Body requirements ahead of MDR
By Stewart Eisenhart, Emergo Group The European Medical Device Coordinating Group (MDCG) has updated a Question and Answer resource document covering compliance requirements related to Notified Bodies and joint assessments under the upcoming Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR). Get the full story here at the Emergo Group’s blog. The […]
West Pharmaceutical Services launches two elastomer products
West Pharmaceutical Services (NYSE:WST) yesterday said it launched two new elastomer products, the 4040/40 formulation elastomer and an extension of its AccelTRA component program. The 4040/40 formulation was created using customer insights to improve performance and reliability. It comes in two stopper designs in 13mm and 20mm sizes with a universal design to deliver high functionality […]
EU MDCG weighs in on medical device certification issues
By Ronald Boumans, Emergo Group On October 4, the Medical Devices Coordination Group (MDCG) issued a guidance document on the validity of certificates issued under the (Active Implantable) Medical Devices Directive (AIMDD), following the Date of Application of the Medical Devices Regulation (EU) 2017/745 (MDR). These so-called “legacy devices” can be placed on the market […]
- « Previous Page
- 1
- 2
- 3
- 4
- …
- 48
- Next Page »
Drug Delivery Business News
@DrugDeliveryNow
LinkedIn