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Blood Management
Nuwellis can’t get a quorum for shareholder vote
Nuwellis (Nasdaq:NUWE) announced today that it convened and adjourned its meeting of stockholders due to a failure to reach a quorum. The fluid overload treatment developer held the meeting on Dec. 7 without any business conducted due to the lack of quorum. Minneapolis-based Nuwellis develops the Aquadex SmartFlow system for ultrafiltration therapy. The company describes […]
FDA clears next-gen hemostasis system from HemoSonics
HemoSonics announced today that it received FDA 510(k) clearance for its Quantra hemostasis system with the QStat cartridge. FDA clearance expands the Quantra system’s indications to include trauma and liver transplantation procedures. Durham, North Carolina-based HemoSonics designed the next-generation system to increase Quanta’s overall diagnostic capabilities. It covers the broadest range of indications of any […]
Nasdaq grants Nuwellis 180-day extension to comply with listing requirement
Nuwellis (Nasdaq:NUWE) announced today that the Nasdaq market granted it a 180-day extension to regain compliance. Minneapolis-based Nuwellis must comply with the market’s minimum $1 bid price requirement for continued listing. The extension of 180 calendar days follows the expiration of its initial 180-day period to regain compliance on Nov. 28. As a result, Nuwellis […]
ReCor reports more positive ultrasound renal denervation results
ReCor Medical said its Paradise ultrasound renal denervation (uRDN) treatment showed consistent and significant blood pressure reductions in an analysis of pooled data from ReCor’s three Radiance randomized hypertension studies. “Pooling the data from the Radiance program demonstrates that treatment with the Paradise uRDN System results in a consistent reduction in blood pressure across differing […]
FDA clears heat purification, remote therapy from Fresenius
Fresenius Medical Care North America (FMCNA) recently announced FDA clearances for two of its technologies used in dialysis care. Today, the Waltham, Massachusetts-based company announced FDA clearance for the AquaA water system. The company designed it as a water purification system for hemodialysis. Yesterday, the FDA granted 510(k) clearance to upgrade Fresenius’ Liberty Select cycler. […]
Nuwellis appoints new CFO following $11M public offering
Nuwellis (Nasdaq:NUWE) today announced it appointed Lynn Blake as chief financial officer on news that it closed an $11 million underwritten public offering. Blake’s appointment is effective immediately. She brings more than two decades of senior financial leadership to the Minneapolis-based company. “Nuwellis is entering our next phase of commercial development with significant new opportunities in […]
Nuwellis prices $9.6M upsized offering
Nuwellis (Nasdaq:NUWE) announced today that it priced an underwritten public offering worth approximately $9.6 million. The Minneapolis-based fluid overload treatment developer formerly operated as CHF Solutions. Nuwellis is offering preferred stock, common stock and warrants. It expects gross proceeds to total $9.6 million before deducting discounts, commissions and offering expenses, according to a news release. […]
Haemonetics names Roy Galvin president of global plasma and blood center
Haemonetics (NYSE:HAE) announced today that it appointed Roy Galvin as president of its global plasma and blood center. Galvin’s position becomes effective Oct. 10, 2022. He will report to Haemonetics President and CEO Chris Simon. His responsibilities in the role include driving growth objectives and advancing the company’s leadership positions and innovation, according to a […]
FDA clears Nexpowder endoscopic hemostasis system from Medtronic
Medtronic (NYSE:MDT) announced that it received FDA clearance for its Nexpowder endoscopic hemostasis system. Nexpowder uses a noncontact, nonthermal and nontraumatic hemostatic powder. The powder sprays through a catheter that features a proprietary powder-coating technology for minimized clogging. The Nexpowder design provides improved visibility and control in the treatment of upper gastrointestinal (GI) nonvariceal bleeding. […]
ReCor Medical ultrasound renal denervation trial meets primary efficacy endpoint
ReCor Medical announced that a trial for its Paradise ultrasound renal denervation (uRDN) treatment met its primary efficacy endpoint. Palo Alto, California-based ReCor’s RADIANCE II pivotal trial evaluated Paradise as a treatment for hypertension. The trial operated under FDA investigational device exemption. ReCor presented results at TCT 2022 in Boston. They follow the company’s July […]