Inspira Technologies this week announced it appointed Adi Rizansky Nir as chief medical officer. Nir will play a critical role in overseeing and guiding Inspira’s medical operations and strategic initiatives. She will collaborate closely with the company’s executive leadership team, medical stage and scientific advisory board to develop and implement innovative strategies that enhance patient […]
Blood Management
Onward completes first-in-human use of movement-restoring lead
Onward Medical announced today that it successfully completed the first-in-human use of its investigational ARC-IM lead. Eindhoven, the Netherlands-based Onward designed the lead to restore movement, function and independence in people with spinal cord injury (SCI). The company developed ARC-IM to deliver targeted electrical pulses to the spinal cord. It represents a key component of […]
FDA clears vascular biometric monitor from CardieX
CardieX announced today that it received FDA 510(k) clearance for its Conneqt Pulse vital signs monitor system. Irvine, California-based CardieX designed Pulse for vital signs monitoring for use at home, by clinicians and in clinical trials. It provides measurements of both brachial blood pressure and central blood pressure, plus other vascular health biomarkers. Pulse uses […]
Abbott wins duo of FDA clearances for CentriMag life support system
Abbott announced today that it received two FDA clearances for its CentriMag system for life support. The agency cleared the CentriMag blood pump for longer-term use in adults using the CentriMag system. These adults require extracorporeal membrane oxygenation (ECMO) to save their life. Longer-term support provides physicians more time to assess the next steps and […]
Fresenius Kabi launches single-needle option for extracorporeal photopheresis
Fresenius Kabi announced the availability of a single-needle venous access option for its Amicus extracorporeal photopheresis (ECP) system. The company announced its availability at the 49th annual meeting of the European Society for Blood and Marrow Transplantation (EBMT). Fresenius Kabi first launched the Amicus Blue system with online ECP in Europe in 2019 with double-needle venous access […]
Olympus launches EndoClot products for gastrointestinal procedures
Olympus announced the launch of its EndoClot offerings for use in gastrointestinal (GI) procedures in the Europe, Middle East and Africa (EMEA) region. The EndoClot portfolio supports hemostasis and lifting in endoscopic submucosal dissection or resection in GI procedures. Olympus launched the EndoClot adhesive, the EndoClot polysaccharide hemostatic spray and the EndoClot submucosal injection solution. […]
BD unveils ultrasound tech for IV insertions
BD announced today that it launched a new ultrasound device to help clinicians achieve optimal IV placement. The new, easy-to-use, advanced ultrasound device — called the Prevue II — features a special probe. BD designed the Prevue II to address an unmet need in IV access through real-time needle depth markers. Franklin Lakes, New Jersey–based […]
Getinge’s Datascope has its second Class I recall in a month
The FDA issued a notice determining another recall of Getinge subsidiary Datascope’s Cardiosave intra-aortic balloon pumps (IABPs) as Class I, the most serious kind. This recall relates to the Swedish medtech company’s Cardiosave Hybrid and Cardiosave Rescue IABPs. Both devices were subject to a separate Class I recall earlier this month. The company also initiated recall that […]
Study backs LimFlow system for treating chronic limb-threatening ischemia
LimFlow announced today that new study results demonstrated statistically significant survival with its chronic limb-threatening ischemia (CLTI) treatment. Paris-based LimFlow’s results came from its Promise II U.S. pivotal trial. They were published in today’s issue of the New England Journal of Medicine (NEJM). Data demonstrated 66% amputation-free survival at six months with the LimFlow system. This […]
Getinge’s Datascope has another serious intra-aortic balloon pump recall
The FDA issued a notice determining a recall of Getinge subsidiary Datascope’s Cardiosave intra-aortic balloon pumps (IABPs) as Class I, the most serious kind. This recall relates to the Swedish medtech company’s Cardiosave Hybrid and Cardiosave Rescue IABPs. Both devices were subject to a separate recall that the FDA determined was Class I in December […]
FDA clears Haemonetics next-gen autotransfusion system software
Haemonetics (NYSE:HAE) announced today that it received FDA 510(k) clearance for next-generation software for the Cell Saver Elite+ autotransfusion system. Boston-based Haemonetics began a full market release for the software update, named Intelligent Control. It designed the software to offer key enhancements to simplify operations, support efficiency and improve user experience. Cell Saver Elite+ allows […]
