Fresenius Medical Care announced today that it received FDA clearance for its 5008X hemodialysis system. The company said this marks a step toward bringing a new standard of care in dialysis therapy to the U.S. Bad Homburg, Germany-based Fresenius can now begin U.S.-based clinical evaluations and user studies ahead of a broad launch in 2025. […]
Blood Management
J&J’s Cerenovus launches next-gen stroke revascularization catheter
Johnson & Johnson MedTech’s Cerenovus today announced the launch of its next-generation CereGlide 71 intermediate catheter with TruCourse. The catheter’s indication covers the revascularization of patients suffering from acute ischemic stroke. It joins the company’s planned CereGlide family of catheters set to enhance the Cerenovus Stroke Solutions portfolio. The company said it optimized the system […]
Procyrion raises $57.7M Series E for circulatory support device
Procyrion announced today that it completed a $57.7 million Series E funding round to support its Aortix device. Fannin Partners led the round, which included the conversion of $10 million in interim financing. New and existing family/multi-family office investors partnered with Fannin Partners in the financing. Returning investors, including BlueBird Ventures and an undisclosed strategic […]
Onward begins neurostim study to address post-spinal cord injury hemodynamic instability
Onward Medical announced today that it began the HemON NL clinical feasibility study to evaluate its ARC-IM neurostimulation therapy. Onward said that, in late 2023, a study participant received the investigational ARC-IM neurostimulator and lead implant. This study aims to assess the safety and effectiveness of the therapy to address hemodynamic instability after spinal cord […]
LivaNova to wind down advanced circulatory support unit, focus on cardiopulmonary, neuromod
LivaNova announced today that it intends to begin winding down its advanced circulatory support (ACS) business unit. The orderly wind-down is part of an effort to focus on the company’s core cardiopulmonary (CP) and neuromodulation units. ACS generated approximately just 4% of LivaNova’s net revenue for the nine months ended Sept. 30, 2023. The company […]
FDA clears fingertip blood collection device from BD
BD announced today that the FDA granted 510(k) clearance to its MiniDraw novel blood collection device. Franklin Lakes, New Jersey-based BD’s device obtains blood samples from a fingerstick, producing lab-quality results for commonly ordered blood tests. BD designed MiniDraw as a less invasive device compared to traditional venous blood draw. A trained healthcare worker can […]
Procyrion enrolls first patient in IDE trial for mechanical circulatory support tech
Procyrion announced today that it enrolled the first patient in its investigational device exemption trial of the Aortix system. The DRAIN-HF study evaluates the Aortix percutaneous mechanical circulatory support (pMCS) technology. Patients in the trial present acute decompensated heart failure (ADHF) and remain unresponsive to standard medical therapy. Dr. Bassem Chehab enrolled the first patient […]
Medtronic reports first patient treated with Symplicity Spyral renal denervation system
Medtronic announced that doctors completed the first commercial case in the U.S. with its Symplicity Spyral renal denervation (RDN) system. Also known as the Symplicity blood pressure procedure, Symplicity Spyral treats high blood pressure, or hypertension. The first procedure follows the landmark approval for the system earlier this month. Approval made Medtronic the second company […]
Cytovale raises $84M Series C for sepsis diagnostic
Cytovale announced today that it raised $84 million in a Series C funding round to support its rapid sepsis diagnosis test. San Francisco-based Cytovale plans to use the funds to further expand the reach of its FDA-cleared IntelliSep sepsis test. The FDA cleared IntelliSep, which aids hospital emergency departments and health systems, in January. IntelliSep […]
Ethicon unveils hemostatic sealing patch in Europe
Johnson & Johnson MedTech’s Ethicon today announced the European approval and introduction of Ethizia, its hemostatic sealing patch. The adjunctive hemostat solution helps to achieve sustained hemostasis in difficult to control bleeding situations. Ethizia features unique synthetic polymer technology for maximum adaptability. Ethicon said it’s the first and only hemostatic matrix designed to be equally […]
BD launches next-gen needle-free blood draw tech
BD announced today that it launched new, FDA-cleared needle-free blood draw technology. The launch of the technology helps to further enable the company’s “One-Stick Hospital Stay” initiative. BD announced this initiative more than two years ago in an effort to transform the patient experience. With FDA 510(k) clearance, BD can now offer its new PIVO […]