By Mark Leimbeck and Stewart Eisenhart, Emergo Group The US Food and Drug Administration has granted Recognized Consensus Standard status to the third edition of the ISO 14071 risk management standard for medical devices and IVD products. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]
Neurelis wins FDA approval for seizure rescue nasal spray
Neurelis today said it won FDA approval for its Valoco seizure rescue nasal spray. Valtoco is approved to use by a care partner outside of a medical setting to treat intermittent, stereotypic episodes of seizure activity. It is designed for people with epilepsy aged 6 or older. Valtoco also uses the company’s Intravail formula for […]
TriSalus launches TriNav Infusion System
TriSalus this week launched its TriNav Infusion System. The infusion system is powered by the company’s Pressure-Enabled Drug Delivery (PEDD) approach with SmartValve technology and is designed to help with the infusion barriers that can limit therapeutic uptake in solid tumors. It gives interventional radiologists intravascular tumor access and improved traceability, compatibility with standard angiographic […]
Tandem Diabetes Care appoints executive VP of strategy and corporate development
Tandem Diabetes Care (NSDQ:TNDM) this week said it appointed Elizabeth Gasser as executive VP of strategy and corporate development. Prior to joining the company, Gasser was an independent adviser for Tandem Diabetes Care. She has also led the corporate strategy function at Qualcomm and has held a number of leadership roles at Openwave Systems. “Liz has […]
Prasco launches generic NuvaRing
Prasco this week said it launched its authorized generic NuvaRing. The generic etonogestrel/ethinyl vaginal ring is a small, flexible vaginal ring that is used by women as a form of birth control. The NuvaRing releases a continuous low dose of hormones for three weeks at a time. “We are proud to launch the authorized generic […]
Medicina recalls IV Luer Slip syringes
Medicina is recalling its IV Luer Slip syringe due to incorrect packaging. According to the company, syringes were incorrectly packaged with a needle, which means they are not sterile and could cause a needle stick injury. The device affected by the recall is 3ml Luer Slip syringe without needle with Medicina product code IVS03, NHS […]
Eitan Group signs service agreement with Integrated Medical Systems
The Eitan Group this week said it signed a service partnership with integrated Medical Systems. Through the agreement, Integrated medical Systems will be the service provider for the Eitan Group’s Sapphire infusion pumps that are used in hospital-based and alternate site infusion. “For over two decades, IMS has worked to provide innovative solutions for alternate […]
FDA details framework for abbreviated 510(k) medical device review pathway
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has published a high-level framework for its Safety and Performance Based Pathway, an expedited 510(k) premarket review process for qualifying medical devices announced earlier in 2019. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]
Aptar wins FDA clearance for ready-to-use seizure treatment device
AptarGroup today said it won FDA approval for its Unidose Liquid System that treats acute repetitive seizures in people who have epilepsy. The Unidose Liquid System is a device that delivers a nasal rescue treatment that is ready-to-use when and where a seizure cluster occurs. “This approval and successful market launch further demonstrate the broad […]
Leo Pharma, Portal Instruments partner to develop needle-free drug delivery device
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 […]
