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, […]
Drug-Device Combinations
FDA approves Boston Scientific’s Ranger drug-coated balloon
Boston Scientific (NYSE:BSX) today said it received FDA approval for its Ranger drug-coated balloon for peripheral artery disease. The balloon’s creators designed it to treat peripheral artery disease (PAD) in the superficial femoral artery and proximal popliteal artery — with a low therapeutic drug dose and coating to transfer the drug into the tissue. Get the […]
Baxter has a serious infusion pump recall
Baxter (NYSE:BAX) has issued an urgent device correction involving hundreds of thousands of Sigma Spectrum infusion pumps in which it warns that improper cleaning could cause corrosion around the batteries. So far, Baxter has received 16 reports of serious injuries related to the problem. FDA has labeled the recall as Class I, its most serious level. […]
ivWatch appoints new COO
Continuous IV monitoring system developer ivWatch announced that it appointed Jaclyn Lautz as its new chief operating officer. Lautz assumes the newly created position at the company, having previously led its research and development division. Her new role will include manufacturing, human resources and operations as well in an effort to drive efficiency and scalability of […]
Kala Pharmaceuticals wins FDA nod for dry eye treatment
Kala Pharmaceuticals announced that it received FDA approval for its Eysuvis treatment for signs and symptoms of dry eye disease. Watertown, Mass.-based Kala’s Eysuvis loteprednol etabonate ophthalmic suspension uses the company’s Ampplify mucus-penetrating particle (MPP) drug delivery technology to enhance the penetration of loteprednol etabonate (LE) into target tissue on the ocular surface, according to […]
Amazon, Onica to support digital health for Teva’s Digihaler
Teva Respiratory (NYSE:TEVA) announced that it is collaborating with Amazon Web Services (AWS) and Onica to build and host its digital health platform. The Teva Pharmaceuticals affiliate’s digital health platform is a cloud-based backend data system designed to support its FDA-approved Digihaler portfolio of breath-actuated digital inhalers and its companion mobile app that tracks inhaler events […]
J&J exec denies pressure to rush COVID-19 vaccine
Johnson & Johnson’s (NYSE:JNJ) chief scientific officer said today that the first doses of his company’s COVID-19 vaccine could be available for frontline healthcare workers in January or February, but added the company isn’t rushing it. If granted an emergency use authorization by the FDA, that’s the earliest Dr. Paul Stoffels said the single-dose vaccine developed […]
J&J exec denies pressure to rush COVID-19 vaccine
Johnson & Johnson’s (NYSE:JNJ) chief scientific officer said today that the first doses of his company’s COVID-19 vaccine could be available for frontline healthcare workers in January or February, but added the company isn’t rushing it. If granted an emergency use authorization by the FDA, that’s the earliest Dr. Paul Stoffels said the single-dose vaccine developed […]
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 said […]
HHS gives Vaxxas $22M to support vaccine patch tech
Vaxxas announced today that it has received a $22 million award from the Biomedical Advanced Research and Development Authority (BARDA) at U.S. HHS to support a clinical study involving the company’s vaccine-delivery patch. The money will mostly pay for a Phase 1 clinical study in which Vaxxas’ high-density micro-array patch (HD-MAP) delivering pandemic influenza vaccine to […]
FDA labels another BD Alaris recall Class I
The FDA announced today that the August recall of a Becton Dickinson (NYSE:BDX) Alaris pump module is Class I, the most serious kind. BD Alaris pump module model 8100 and the Alaris pump module door assembly replacement kits (part numbers 49000346, 49000239, 49000438 and 49000439) were included in the Aug. 4 recall. Those models and parts were […]