The FDA has identified another recall for the Alaris infusion pump from BD (NYSE:BDX) as Class I, the most serious kind of recall. BD’s latest recall, initiated on March 3, 2021, involves its BD Alaris infusion pump module system, which includes an infusion pump and vital signs monitoring system with a PC unit, the Guardrails Suite MX […]
BD
Vicarious Surgical to go public in $1.1B SPAC deal
Vicarious Surgical will go public through a $1.1 billion special purpose acquisition company (SPAC) deal, the robotic surgery pioneer announced today. Vicarious, which has sought to bring robotics and virtual reality to minimally invasive surgery, will trade on the New York Stock Exchange under the symbol RBOT after the merger with D8 Holdings. Hong Kong–based […]
BD lands FDA clearance for hemodialysis catheter
BD (NYSE:BDX) this week said it has received FDA 510(k) clearance for its Pristine long-term hemodialysis catheter. The catheter has a side-hole free symmetric Y-tip distal lumen design that is designed to minimize thrombus adhesion and help facilitate blood clot aspiration prior to hemodialysis treatment. Its symmetric tip is designed to help minimize recirculation rates […]
MedTech 100 roundup: Heading back to previous heights?
Although March brought on tough times for top stocks in the medtech industry, April is already showing signs of a rebound. The year’s strong start, during which MassDevice‘s MedTech 100 index notched an all-time best of 110.96 points (Feb. 15) came to an end later that month and carried over into March, with the index hitting its lowest […]
DTW Podcast: Earnhardt shares how Abbott shifted gears to counter pandemic; Grail still looks to upend oncology
This week, we’ll talk with Abbott’s medical devices EVP Lisa Earnhardt about how the life sciences giant pivoted during the pandemic. Earnhardt shares what programs were given greater priority when the lockdown’s impact became clear and why the company performed so well in one of its key businesses. We also explore this week’s news that […]
FDA authorizes use of over-the-counter COVID-19 tests for screening
The FDA announced today that it authorized several COVID-19 tests for over-the-counter use in asymptomatic screening. Among the tests authorized were the BinaxNow Ag card from Abbott (which includes point-of-care screening) and the Quidel Quick-View at-home test. FDA also authorized the BD Veritor Plus system for POC screening with a prescription. “BD is supporting the […]
FDA warns on use of certain surgical mesh in breast reconstruction
Two surgical mesh brands used off-label in breast reconstruction surgery have had “significantly higher major complication rates,” according to an FDA analysis. Patients implanted with FlexHD by MTF Biologics and AlloMax by BD had higher rates of explantation, reoperations and infections two years after surgery when compared with patients who received one of two other […]
BD plans $65M plant in Arizona
BD (NYSE:BDX) announced today that it will invest $65 million to build a state-of-the-art supply chain hub in Tucson, Ariz. Franklin Lakes, N.J.-based BD’s new 120,000 square-foot facility is slated to become a hub for the company’s supply chain by serving as a final-stage manufacturing and sterilization center, according to a news release. Get the full […]
Medtronic veteran Brooke Story to lead BD’s Integrated Diagnostic Solutions
Another Medtronic veteran is leaving the company to take on new challenges elsewhere, and this time it involves BD. Brooke Story will become worldwide president of BD Integrated Diagnostic Solutions, effective April 5. Story has been at Medtronic for 15 years, most recently serving as president of Pelvic Health and Gastric Therapies at the medtech […]
BD lands EUA for COVID/flu test
The FDA issued a letter to BD (NYSE:BDX) to confirm the emergency use authorization of its Veritor system for detecting COVID-19 and flu. According to the letter, dated last week, the Veritor system was authorized for the simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen and/or influenza A and B nucleoprotein antigens directly from […]
BD expands recall of ChloraPrep 3 ml applicator
BD announced that it revised a previous press release from last week to expand a voluntary recall of its ChloraPrep 3 mL applicator. Franklin Lakes, N.J.-based BD initiated the recall for specified catalog numbers of the applicator device on June 23, 2020, due to possible fungal contamination under certain environmental conditions, according to a news […]