Becton Dickinson (NYSE:BDX) last week issued a notice to warn on potential vulnerabilities with its Alaris infusion pumps. The notification applies to BD’s Alaris PC unit, model 8015, versions 9.33.1 and earlier, as well as the Alaris systems manager, versions 4.33 and earlier, according to a news release. BD was made aware of a network session […]
Drug-Device Combinations
Baxter lands major DoD contract
The U.S. Defense Dept. (DoD) announced that it awarded Baxter (NYSE:BAX) $40 million for its infusion pumps and accessories. Baxter’s contract includes a maximum $40 million fixed-price award with economic-price-adjustment and indefinite-delivery/indefinite-quantity for its infusion pumps and accessories. The competitive acquisition had 105 offers received. Get the full story at our sister site, Drug Delivery Business […]
ICU Medical ticks up on Street-beating Q3, raised guidance
ICU Medical (NSDQ:ICUI) shares rose today on third-quarter results that came in ahead of the consensus forecast. The San Clemente, Calif.-based infusion therapy and critical care technology developer posted profits of $25 million, or $1.16 per share, on sales of $318.6 million for the three months ended Sept. 30, 2020, for a -5.9% bottom-line slide on […]
BD beats The Street in Q4, posts 2021 guidance
Becton Dickinson (NYSE:BDX) reported Street-beating fourth-quarter financial results and revealed its 2021 fiscal guidance. The Franklin Lakes, N.J.-based company posted profits of $128 million, or 36¢ per share, on sales of $4.8 billion for the three months ended Sept. 30, 2020, for a -21.5% bottom-line slide on sales growth of 4.4%. Adjusted to exclude one-time items, […]
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, […]
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 […]