Smiths Medical is recalling half a million Normoflo irrigation fluid warmers and warmer sets due to the potential for aluminum ions to leach into warmed fluids. The recall has been designated as a Class I recall — the most serious kind — by the FDA. According to an FDA notice, when fluid circulates through a […]
Blood Management
Stryker completes Gauss Surgical acquisition
Stryker (NYSE:SYK) announced today that it acquired Gauss Surgical and its Triton platform for an undisclosed amount. Menlo Park, California-based Gauss Surgical designed the Triton artificial intelligence-enabled platform for the real-time monitoring of blood loss during surgery. The platform has demonstrated improvements in maternal and surgical care through earlier recognition of hemorrhage leading to earlier […]
Boston Scientific initiates trial for EkoSonic endovascular system
Boston Scientific (NYSE:BSX) announced today that it began enrollment for a clinical trial of its EkoSonic endovascular system (EKOS). Marlborough, Mass.–based Boston Scientific’s HI-PEITHO trial, a collaborative research study with the Pulmonary Embolism Response Team (PERT) Consortium and the University Medical Center of the Johannes Gutenberg University of Mainz, will compare EkoSonic in combination with […]
Philips wins breakthrough nod for laser-assisted IVC filter removal device
Royal Philips (NYSE:PHG) announced today that it received FDA breakthrough device designation for its laser-assisted IVC filter removal device. Amsterdam-based Philips designed its laser-assisted inferior vena cava (IVC) filter removal device to ablate tissue to remove an IVC filter when previous methods of removal have failed, according to a news release. IVC filters are used […]
BD announces ‘One-Stick Hospital Stay’ blood collection initiative
BD (NYSE:BDX) announced today that it plans to transform the patient experience through a “One-Stick Hospital Stay” blood collection solution. Franklin Lakes, N.J.–based BD said in a news release that its recent acquisition of Velano Vascular and its needle-free technology for high-quality blood draws from existing peripheral intravenous catheter (PIVC) lines offers a way to […]
Surmodics acquires Vetex Medical and its mechanical thrombectomy catheter
Surmodics (NSDQ:SRDX) announced that it acquired Vetex Medical, a developer and manufacturer of venous clot removal solutions. Buying Galway, Ireland–based Vetex Medical provides Surmodics a second FDA-cleared device for its thrombectomy portfolio. Vetex designed the ReVene thrombectomy catheter to remove large, mixed-morphology blood clots commonly found with venous thromboembolism (VTE). Get the full story at our sister […]
Outset Medical CFO to leave, interim replacement named
Outset Medical (NSDQ:OM) announced that CFO Rebecca Chambers will step down and Nabeel Ahmed will take over in an interim capacity. San Jose, Calif.-based Outset said in a news release that Chambers will depart to pursue other opportunities, effective on July 16, 2021. Ahmed, current VP of finance at the company, will assume the role […]
Abbott wins new FDA approvals for stent family including nod for next-gen Xience Skypoint
Abbott (NYSE:ABT) announced today that the Xience stent family received FDA approval for one-month dual antiplatelet therapy (DAPT) labeling. The FDA’s approval for one-month (as short as 28 days) DAPT labeling applies to high bleeding risk (HBR) patients in the U.S., according to a news release. The company also recently received CE mark approval in […]
Quanta Dialysis Technologies raises $245M for portable hemodialysis system
Quanta Dialysis Technologies announced that it raised $245 million in an oversubscribed and upsized Series D financing round. Alcester, England/Beverly, Mass.-based Quanta touted the financing as the largest private funding round for a dialysis device company in history, according to a news release. “We are delighted to attract such a strong syndicate of investors, which […]
RapidAI launches workflow platform for pulmonary embolism
RapidAI announced today that it launched its mobile and web-based app to aid in the treatment of pulmonary embolism (PE). San Mateo, Calif.-based RapidAI made available the Rapid Workflow for PE, which it designed to align hospital teams on the treatment of patients suspected of having a pulmonary embolism, according to a news release. Rapid […]
Outset Medical hires Amazon’s top health AI engineer as its CTO
Outset Medical (NSDQ:OM) announced today that it appointed Jean-Olivier Racine as its new chief technology officer. Racine, a veteran of more than two decades in the technology industry, previously worked as the head of engineering and science for Amazon Web Services (AWS) Health AI, where he managed Amazon Comprehend Medical, Amazon HealthLake and more health […]
