Concept Medical said yesterday that it won breakthrough designation from the FDA for its MagicTouch AVF drug-coated balloon. MagicTouch AVF is designed to treat stenotic lesions of arteriovenous fistulae or arteriovenous graft in hemodialysis treatment of renal failure. India-based Concept Medical’s device is indicated for use in percutaneous transluminal angioplasty. The PTA procedure, using Concept […]
Eitan taps InfuSystem for Sapphire pump maintenance deal
Eitan Group said today that it inked a deal with InfuSystem (NYSE:INFU) for repair services on its fleet of Sapphire infusion pumps. Madison Heights, Mich.-based InfuSystem plans to offer flat and al-la-carte options for Sapphire service and repair, citing a three-business-day turnaround goal on repairs. “Our partnership with Eitan Group will create savings and improve […]
Senseonics touts long-term safety data on home-use Eversense
Senseonics (NYSE:SENS) yesterday touted real-world data it said demonstrated the safety and lack of adverse events with its Eversense continuous glucose monitoring system for people with diabetes. Eversense is a long-term, implantable GCM sensor with a transmitter that sends discreet vibrations to alert users of low or high glucose. The device can be removed, recharged and […]
Surmodics reaps $10m from Abbott on SurVeil balloon milestone
Surmodics (NSDQ:SRDX) said today that it’s due for a $10 million milestone payment from Abbott (NYSE:ABT) after closing enrollment for the Transcend pivotal trial of its SurVeil drug-coated balloon for treating peripheral artery disease. Abbott in February 2018 paid $25 million up front for the global commercialization rights to the SurVeil device, which uses a proprietary […]
Whistleblowers accuse Fla. VA hospital of ignoring Alaris recall
Staff members at a Florida U.S. Veterans Affairs Dept. hospital reportedly said leadership ignored the recall of the Alaris infusion pump made by Becton Dickinson (NYSE:BDX). Leaders at the James Haley Veterans’ Hospital in Tampa dismissed repeated warnings about BD’s device over multiple weeks, even after a patient’s life was endangered, the Military Times reported. […]
Senseonics touts real-world CGM data
Senseonics (NYSE:SENS) announced yesterday that real-world data from its Eversense continuous glucose monitoring system reflected strong performance and safety. The data, published in Diabetes Technology and Therapeutics, included the first 205 U.S. patients to use Germantown, Md.-based Senseonics’ Eversense system over a 90-day wear period. Zero device or procedure-related adverse events were reported with the […]
Enable Injections inks deal with Genentech
Enable Injections said yesterday that it entered a developmental partnership with Genentech for the Enable enFuse device. Cincinnati-based Enable’s enFuse is an on-body drug delivery platform containing a drug transfer system compatible with syringes and vial containers. Currently, the enFuse is being developed for subcutaneous delivery of large volumes potentially rising to 50 mL. The […]
FDA wants more on new manufacturing process from Clearside Biomedical
Clearside Biomedical (NSDQ:CLSD) said today that the FDA ordered the company to provide stability data on its new manufacturing process for triamcinolone acetonide suspension, pushing the timeline on the agency’s decision into next year. Alpharetta, Ga.-based Clearside’s Xipere device is a suprachoroidal injection designed for the treatment of macular edema associated with uveitis. Clearside said […]
Baxter foundation, Direct Relief ink diabetes pact
Baxter (NYSE:BAX) and Direct Relief announced today that they are launching a three-year program awarding funding to health centers and free and charitable clinics that are working to improve diabetes outcomes for patients. The program, Transformative Innovation Awards for Community Health: Incorporating Nutrition to Improve Diabetes Health Outcomes, will award $750,000 to the centers and […]
Adherium inks digital health deal with Summatix
Adherium (ASX:ADR) announced a data-based initiative with Summatix to allow clinicians to improve care of patients with asthma and chronic obstructive pulmonary disease across the world. New Zealand-based Adherium and Australia-based Summatix plan to build upon an existing relationship, as the former will gain access to Summatix’s platform to release data from its Hailie sensors […]
