Baxter (NYSE:BAX) announced today that study findings supported stroke volume and cardiac monitoring for predicting patient outcomes. The Baxter-sponsored study found that monitoring stroke volume and cardiac output trends for patients with critical conditions may offer vital insight into cardiac function and aid in predicting patient outcomes, including mortality. Deerfield, Illinois-based Baxter’s study findings were […]
Blood Management
FDA clears Baxter’s continuous renal replacement therapy system
Baxter (NYSE:BAX) announced today that it received FDA 510(k) clearance for its ST Set in continuous renal replacement therapy (CRRT). Deerfield, Illinois-based Baxter designed the ST Set as a pre-connected, disposable, extracorporeal circuit that provides blood purification through a semipermeable membrane for use with the PrisMax or Prismaflex control units. The platform has been available […]
Olympus enters exclusive U.S. distribution agreement with EndoClot Plus
Olympus (TYO:7733) announced today that it entered into a strategic distribution agreement with EndoClot Plus. EndoClot Plus develops technologies in the hemostasis space, including the EndoClot PHS — a nonthermal, nontraumatic method for achieving hemostasis with GI bleeds designed to help gastroenterologists stop bleeding rapidly and reliably. The biomaterial therapeutic solution developer is based in […]
ReCor Medical completes enrollment in renal denervation trial for treating hypertension
ReCor Medical announced today that it completed enrollment in its Radiance-II pivotal trial of the Paradise ultrasound renal denervation (uRDN) system. The Radiance-II trial of the Paradise uRDN system will evaluate the platform in the treatment of uncontrolled hypertension in patients on zero-to-two antihypertensive oral medications. ReCor Medical designed its Paradise platform as a device-based, […]
FDA clears Biobeat’s remote vital sign monitoring system
Biobeat announced today that it received FDA 510(k) clearance for its wearable remote patient monitoring device. FDA clearance allows the wearable device to monitor respiratory rate and body temperature in addition to cuffless blood pressure, blood oxygen saturation and pulse rate. Petah Tikva, Israel-based Biobeat’s wireless wrist and chest monitoring devices became the first of […]
Merit Medical Systems recalls some Access hemostasis valves
Merit Medical (Nasdaq:MMSI) issued an urgent field safety notice in Europe to alert users to a recall of some of its hemostasis valves. South Jordan, Utah-based Merit initiated the voluntary recall of its Access-9 and AccessPLUS hemostasis valves as a result of a defect relating to a recent design change made to improve manufacturability, according […]
Haemonetics names James D’Arecca as chief financial officer
Haemonetics (NYSE:HAE) this week appointed James D’Arecca as chief financial officer, effective on April 11. D’Arecca will oversee the company’s treasury, controllership and accounting, investor relations, tax, information technology and financial planning and analysis functions. He will report directly to president and CEO Chris Simon. He succeeds William Burke who will remain with Haemonetics in an […]
FDA clears Terumo’s next-gen plasma collection device
Terumo (TSE: 4543) announced today that the FDA cleared its Rika next-generation automated plasma collection system. Lakewood, Colorado-based Terumo designed the Rika system to include safety features that minimize operator errors while collecting plasma in 35 minutes or less. According to a news release, the company developed Rika in response to the industry’s need for […]
Merit Medical wins FDA breakthrough nod for microspheres for treating knee osteoarthritis
Merit Medical (Nasdaq:MMSI) announced today that it received FDA breakthrough device designation for its Embosphere microspheres. South Jordan, Utah-based Merit Medical’s breakthrough nod covers the Embosphere microspheres for the genicular artery embolization (GAE) indication for reducing blood flow to the knee to reduce pain and disability caused by knee osteoarthritis. Merit Medical said in a […]
Nuwellis posts mixed bag Q4
Nuwellis (NSDQ:NUWE) shares were up today on fourth-quarter results that were mixed compared to the consensus forecast. The Minneapolis-based fluid overload treatment developer — formerly known as CHF Solutions — posted losses of $4.4 million, or 41¢ per share, on sales of $1.6 million for the three months ended Dec. 31, 2021, for a bottom-line […]
Front Line Medical expands availability of COBRA-OS arterial occlusion system
Front Line Medical recently announced that it expanded the availability of its COBRA-OS aortic occlusion device to meet growing demands. The Ontario, Canada-based company is increasing production of the COBRA-OS (control of bleeding, resuscitation, arterial occlusion system) occluder following patient success rates and expanded interest from hospitals to treat trauma. Get the full story on […]