Eitan Medical (formerly Eitan Group) announced today that the FDA has granted 510(k) clearance to its upgraded Sapphire infusion pump system software Rev15, which includes the infusion pump, administration sets and accessories. The Sapphire infusion system is the company’s flagship infusion device and is used across the U.S. within alternate sites, homecare markets, emergency medical […]
Locate Bio lands FDA breakthrough nod for bone infection device
Regenerative medicine company Locate Bio announced today that the FDA has granted breakthrough device designation to a bone graft/antibiotic combination designed to combat chronic bone infection, also known as osteomyelitis. Osteomyelitis is a progressive, inflammatory infection of the bone, usually caused by bacteria and is estimated to account for up to 50% of all non-trauma […]
Evonik buys polymers business from Durect Corp.
Evonik said today that it has acquired the Lactel PLGA-based polymers business from Durect Corp. All Durect employees associated with the Lactel business in Birmingham, Ala., accepted the offer to join Evonik in similar roles, according to Essen, Germany-based Evonik. The deal closed Dec. 31, 2020. Evonik will integrate the Lactel biodegradable polymers line into its […]
Appeals court nixes GSK’s petition for new trial in Vectura patent spat
The Federal Circuit Court has rejected Glaxo Smith Kline’s (NYSE:GSK) petition for a new trial in a patent case brought by British inhaler company Vectura. The circuit court upheld a May 2019 jury verdict in U.S. District Court for the District of Delaware, awarding Ventura $89.7 million damages for the period from August 2016 through […]
Medtronic launches ‘smart’ insulin pen
Medtronic (NYSE:MDT) today announced the launch of its InPen “smart” insulin pen integrated with real-time Guardian Connect continuous glucose monitor (CGM) data. The Fridley, Minn.-based medtech giant is touting InPen as the first and only FDA-cleared smart insulin pen on the market for people on multiple daily insulin injections. The system is designed to provide real-time […]
Medtronic must face infusion pump lawsuit
A federal judge in Missouri has blocked an effort by Medtronic (NYSE:MDT) to dismiss a lawsuit alleging that the failure of one of its infusion pumps caused “severe and permanent injuries.” Plaintiff Carissa Sullivan, who has cerebral palsy and spastic quadriplegia, claims that the SynchroMed II infusion pump she had implanted in 2011 failed in 2015, causing […]
FDA produces list of ‘essential’ devices, drugs for health, military emergencies
The FDA has released a list of essential medical devices, medicines and “medical countermeasures” that the Trump administration ordered the agency to buy domestically to fight the novel coronavirus and future health and military crises. Devices on the list include diagnostic testing kits and supplies for rapid test development and processing, personal protective equipment, devices […]
What you need to know about analytical testing for drug-device combinations
Pharmaceutical manufacturers need to understand the compatibility and performance of the primary packaging system with both the drug and its delivery system. Jennifer Riter, West Pharmaceutical Services As more pharmaceutical manufacturers develop combination products, they identify new and complex interactions among packaging components and delivery systems. Understanding this interplay is critical to developing a successful […]
Abbott touts Xience DES study results
A pair of studies of Abbott’s Xience drug-eluting stent showed no difference between shorter courses of treatment with dual antiplatelet therapy (DAPT) compared with 12 months of DAPT following implantation of the XIENCE drug-eluting stent (DES) in patients who are at a high risk of bleeding. Abbott presented the late-breaking data today at TCT Connect, the […]
Dexcom, Lilly partner on diabetes management for healthcare providers
Eli Lilly (NYSE:LLY) and Dexcom (NSDQ:DXCM) today announced a joint program for U.S. healthcare providers that includes Lilly’s new, rapid-acting Lyumjev mealtime insulin pen and Dexcom G6 continuous glucose monitoring (CGM) systems. The program is designed to help clinicians use data to inform diabetes management, including promoting the benefits of a new mealtime insulin dose, the companies […]
