BD (NYSE:BDX) announced today that it will build a more than $200 million drug delivery device manufacturing facility in Spain. The approximately $201.5 million (€165 million) high-tech manufacturing facility in Zaragoza, Spain, is expected to create up to 600 jobs by 2030, according to a news release. Get the full story at our sister site, Drug […]
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BD enrolls first patients in arteriovenous endovascular fistula post-market trial
BD (NYSE: BDX) recently announced that it has begun enrollment for its post-market surveillance study of its WavelinQ arteriovenous endovascular fistula device. The Connect-AV trial is a prospective, single-arm, open-label study that will follow WavelinQ EndoAVF system patients for 24 months. Its dual primary effectiveness endpoints are the percentage of subjects dialyzing with successful 2-needle cannulation […]
MedTech 100 roundup: Largest slide for industry in 2021
The medtech industry’s 2021 performance has been all over the place and the past weekend highlighted its topsy-turvy nature. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — had been on the rise since the beginning of April, with its mark of 112.25 on April 16 representing an all-time best and […]
BD to spin off its diabetes business, Q2 earnings beat The Street
BD (NYSE: BDX) announced today that it will spin off its Diabetes Care business as an independent, publicly traded company during the first half of 2022. The Diabetes Care business saw $1.1 billion in sales during BD’s fiscal year ended Sept. 30, 2020, nearly half outside the U.S. The business manufactures roughly 8 billion injection […]
BD’s Alaris pump hit with another serious recall
A medical supply company is recalling BD (NYSE:BDX) Alaris infusion pumps — the third Class I recall for the pumps in recent months, according to the FDA. North Carolina-based Avante Health Solutions issued the Alaris pump recall March 24, 2021, because the bezel repair posts may crack or separate, leading to the inaccurate delivery of […]
4 catheter-based devices to watch for in 2021
Medical device companies are working to gain regulatory approvals and launch new catheter-based devices as the world slowly returns to normal after reeling from the COVID-19 pandemic. As of April 19, the FDA had approved 11 medical devices this year — two of them catheter-based. In comparison, the regulatory agency approved 19 devices by April 19 last year. However, […]
BD names Elizabeth McCombs as chief technology officer
BD today said it has appointed Elizabeth McCombs as executive VP and chief technology officer, effective April 26. McCombs succeeds John DeFord and will be responsible for driving the company’s category innovation strategy and leading research and development activities. “Beth has been an influential leader since joining BD, leading R&D for the medical segment to […]
BD applies for FDA clearance to start shipping Alaris pumps again
BD (NYSE:BDX) said today that it has applied to the FDA for a new clearance for its recall-plagued Alaris infusion pump system. BD has had shipments of Alaris pumps on hold after the FDA called for a comprehensive 510(k) submission to cover a host of software fixes needed following a Class I-level recall in March 2020. Pumps are only […]
Pump problem prompts another Alaris recall
Days after classifying one recall for the Alaris infusion pump, the FDA has issued another Class I recall for the device. On Friday of last week, the FDA issued a Class I recall — the most serious kind — for the BD (NYSE:BDX) Alaris because there is a risk of the keypad lifting up due to fluid entry, […]
Another BD Alaris infusion pump recall is Class I
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 […]
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 […]