Fresenius Medical Care announced today that it launched the newest version of its home hemodialysis (HHD) machine, the NxStage Versi HD with GuideMe software. The new machine features enhancements designed to simplify treatment, increase ease of learning and improve user experience. NxStage Versi HD with GuideMe software picked up FDA clearance in 2023. Fresenius Medical […]
Blood Management
Obvius Robotics earns FDA breakthrough nod for central venous catheterization access system
Obvius Robotics announced today that the FDA granted breakthrough device designation for its Certa access system for central venous catheterization (CVC). CVC procedures require access to one of the great veins (internal jugular, subclavian, or femoral) to place a multi-lumen catheter for rapid replacement of blood volume, administration of emergency medicines and analgesics, and hemodynamic […]
SurGenTec wins FDA nod for bone marrow aspirate kit
SurGenTec announced today that it received FDA 510(k) clearance for its proprietary B-MAN bone marrow aspirate kit. Boca Raton, Florida-based SurGenTec says its B-MAN kit offers a cutting-edge approach to bone marrow aspiration. It utilizes a centrifuge-free method to collect high-quality aspirate with minimal contaminants. The kit’s integrated, diamond-tip trocar works simultaneously with CELLect filtration […]
Haemonetics kicks off full market launch of venous closure device
Haemonetics today announced the full market release of its Vascade MVP XL mid-bore venous closure system. The company made Vascade MVP XL fully available to U.S. hospitals as an option to promote rapid hemostasis. Haemonetics began the initial rollout for the system, which holds FDA premarket approval, in June. That limited launch reached about 80 […]
Diality wins FDA clearance for hemodialysis system
Diality announced today that it received FDA 510(k) clearance for its Moda-flx smart, flexible hemodialysis system. Irvine, California–based Diality designed the system to provide kidney care professionals with a wide range of variable flow rate ranges, integrated reverse osmosis water filtration and an intuitive, easy-to-use graphical user interface. It provides clinicians with the flexibility to […]
VenoStent raises $20M for bioabsorbable perivascular wrap
VenoStent announced today that it picked up an additional $4 million to round out a $20 million Series A financing round. Houston-based VenoStent received the $4 million from Norwest Venture Partners. Good Growth Capital and IAG Capital Partners co-led the entire Series A round. It also received a $3.6 million Small Business Innovation Research (SBIR) […]
Xeltis wins FDA IDE approval for restorative vascular access conduit pivotal trial
Xeltis announced today that it received FDA investigational device exemption (IDE) to begin a pivotal study of its restorative vascular access conduit. aXess enables the creation of a new, permanent, living vessel for hemodialysis vascular access. It combines the safety and patency of arteriovenous fistula (AVF) with the speed to treatment of arteriovenous grafts (AVG). […]
DeepQure wins FDA IDE nod for renal denervation study
DeepQure announced today that it received FDA investigational device exemption (IDE) approval for a study of its HyperQure system. The Seoul, South Korea–based company designed HyperQure to perform renal denervation (RDN) through an extravascular (laparoscopic) approach. DeepQure says it’s the world’s first extravascular RDN medical device for treating resistant hypertension. Though it faced clinical trial […]
FDA clears portable blood, IV fluid warmer from Mequ
Mequ announced today that the FDA granted 510(k) clearance to its M Warmer system, a portable blood and IV fluid warmer platform. The Copenhagen, Denmark–based medtech company offers the warmer for both military and civilian use. It features a portable, user-friendly design that enables the warming of blood and IV fluids regardless of location. That […]
Solventum VP leaves for blood collection kits company
Kurin (San Diego) announced that it has hired a VP out of Solventum, the recently completed spinoff of 3M’s healthcare business. Christine Arme most recently served as VP of Healthcare Systems at Solventum; she joined 3M in 2015. She led the key account organization for the healthcare business’s largest business group, the Medical Surgical business […]
Haemonetics announces $525M offering
Haemonetics announced its intention to offer $525 million in convertible senior notes due 2029 in a private offering. The Boston-based company’s notes accrue interest payable semi-annually in arrears. They mature on June 1, 2029, unless earlier repurchased, redeemed or converted. Haemonetics also expects to grant initial purchasers of the notes an option to purchase up […]
