BD announced today that it plans to initiate a patient data registry for its Rotarex atherectomy system. The registry aims to measure real-world outcomes for patients with peripheral artery disease (PAD). XTRACT, a multi-center, single-arm, post-market registry assesses Rotarex’s clinical performance in U.S. patients with PAD lesions. Co-principal investigators Dr. Prakash Krishnan, an interventional cardiologist, […]
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BD warns on esophagogastric balloon tamponade tubes after death
The FDA issued a notice highlighting a letter issued by BD and its C.R. Bard Urology and Critical Care subsidiary warning of new balloon device instructions. This warning follows one death associated with the device issue. BD sent affected customers a notice updating instructions for all lots of certain esophagogastric balloon tamponade tubes. Such devices, […]
BD files patent infringement lawsuit against Baxter over infusion pump tech
BD (NYSE:BDX) has alleged patent infringement by Baxter (NYSE:BAX) in a new legal complaint related to infusion pump technology. Our sister site, Drug Delivery Business News, reports today that BD filed its complaint in the U.S. District Court for the District of Delaware on May 12, 2025, alleging the “infringing manufacture, use, importation, offer for sale, […]
BD posts mixed Q2, adjusts guidance for tariff impact
BD shares took a hit today on second-quarter results that were mixed compared to the consensus forecast.. Shares of BD dipped 5% to $196.51 apiece in pre-market trading today. The Franklin Lakes, New Jersey–based medtech giant company reported profits of $308 million. That equals $1.07 per share on sales of $5.27 billion for the three […]
BD launches bioabsorbable mesh for hernia repair following FDA nod
BD announced today that it received FDA 510(k) clearance for its Phasix ST umbilical hernia patch. The company has now initiated the launch of Phasix ST, the first and only fully absorbable hernia patch on the market designed specifically for umbilical hernias, according to a news release. Phasix ST features Poly-4-hydroxybutyrate (P4HB), a biologically-derived material. […]
BD launches next-gen AI-powered hemodynamic monitoring tech
BD announced today that it launched a new hemodynamic monitoring platform using predictive AI algorithms. The new technology — HemoSphere Alta — can help clinicians proactively address blood pressure instability and optimize blood flow, according to BD. It helps to avoid potential life-threatening situations during procedures. Franklin Lakes, New Jersey–based BD says HemoSphere Alta becomes […]
BD warns on intravascular catheter
The FDA shared an alert that BD and its Bard subsidiary warned customers of an issue with certain intravascular catheters. BD recommended the removal of certain unused PowerPICC intravascular catheters from use or sale. In-use PowerPICC intravascular catheters also received updated instructions for use. Affected products include the 4 Fr. single lumen PowerPICC, SOLO and […]
Medtech stocks sink in trade war
The past week has been tough on the stocks of major medtech companies, which, like many, are figuring out how to manage the Trump administration’s new global trade war. The S&P 500 briefly entered bear market territory today as it swung wildly in response to chaotic news reports about what the administration and other countries […]
Report: BD is in talks with competitors to sell Life Sciences biz
The Financial Times reports today that BD began discussions with a handful of competitors for the sale of its Life Sciences business. In February, the BD board unanimously authorized management to pursue the separation of its Life Sciences business. The company plans to separate its Biosciences and Diagnostic Solutions unit from the rest of BD. […]
BD treats first patient in study of bioabsorbable scaffold in breast implant revision surgery
BD announced today that investigators treated the first patient in a study of its GalaFlex Lite scaffold system. The FDA investigational device exemption (IDE) trial evaluates GalaFlex Lite in decreasing capsular contracture (CC) recurrence during breast revision surgery. BD aims to use findings to advance its efforts to pick up FDA premarket approval (PMA) for […]
Staar Surgical, BD, Acutus Medical announce layoffs in Southern California
Staar Surgical, BD, and Acutus Medical all filed layoff notices with the state of California over the past month, with more than 200 jobs affected. The WARN notices to the California Employment Development Department this month included: Staar Surgical is letting go of 100 employees in Monrovia and five in Aliso Viejo, with the separations […]
