Becton, Dickinson and Co. (BD) (NYSE:BDX) reported revenue of $4.23 billion for the first quarter of fiscal year 2020, ended Dec. 31, up 1.6% from the same period a year ago. Revenue grew 2.5% on a currency-neutral basis. However, an unexpected regulatory hurdle for its Alaris infusion pumps caused the Franklin Lakes, N.J.-based company to lower its 2020 revenue and earnings guidance. Despite the shadow cast by the Alaris news, BD beat Street expectations for the quarter – clocking in at $4.23 billion vs. $4.18 billion. Read More
Aria CV Inc., which focuses on pulmonary arterial hypertension (PAH), has won a breakthrough device designation from the U.S. FDA for the Aria CV pulmonary hypertension (PH) system. The implanted Aria CV PH system aims to restore the benefits of a healthy, elastic pulmonary artery, which in turn reduces cardiac workload and enhances blood flow. Read More
The FDA has awarded a breakthrough device designation to a polymer film implant to create an artificial endothelial layer in the eye. Known as Endoart, it is designed to replace a non-functioning endothelium, which is the single layer of cells on the inner surface of the cornea. Without it, excess fluid flows into the cornea and can result in severe vision loss. Read More
FDA warning letters to device makers have been conspicuous in their paucity in recent years, but they have been surfacing with greater frequency over the past few months. Read More
Lineage Cell Therapeutics Inc. CEO Brian Culley told BioWorld that concerns about the pace of the company’s dry age-related macular degeneration (AMD) phase I/IIa trial have been alleviated after an independent data safety monitoring board (DSMB) decreed that the study’s protocol-mandated treatment stagger can be removed. Read More
BEIJING – Share prices of Chinese biotechs that partner with Gilead Science Inc. have surged in China this week, after the U.S. firm’s remdesivir was identified as the most promising drug candidate to treat 2019-nCoV. Read More
Med-tech firms raising money in public or private financings, including: Connectyx Technologies, Lunaphore Technologies, Pentixapharm, Rewalk Robotics. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bgi, Bioventrix, Curetis, Fibroline, Gatt Technologies, MGI Tech, Nano-X Imaging, Quaphaco, Smith & Nephew, USArad Holdings. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aria CV, Atlantic Therapeutics, In2bones, Life Spine. Read More
Keeping you up to date on recent developments in diagnostics, including: Raman spectroscopy to monitor blood glucose; A score to predict progressive chronic liver disease; From African genomes, big insights with small sample size. Read More
