ReCor Medical said this week that the FDA approved a new pivotal study of the company’s Paradise ultrasound denervation system for the treatment of hypertension. The Palo Alto, Calif.-based company reported that its trial, Radiance-II, will be a randomized, sham-controlled study in patients with moderate hypertension. The study is designed to demonstrate the Paradise system’s […]
Blood Management
Haemonetics closes $700m debt refi
Haemonetics (NYSE:HAE) said today that it closed the refinancing of some $700 million in debt as part of its restructuring plan. Last November the Braintree, Mass.-based blood management company unveiled plans to cut roughly 11% of its global workforce as it looked to pare $80 million from its annual cash burn by the end of fiscal 2020. […]
Roche launches CoaguCheck Vantus blood coagulation monitor
Roche (OTC:RHHBY) said today it is launching its CoaguCheck Vantus system designed for monitoring blood coagulation, specifically for patients on warfarin therapy. The Switzerland-based company said the CoaguCheck Vantus features built in Bluetooth technology to allow patients to use their smart devices and a compatible application to send results of the coagulation testing to their healthcare […]
Fresenius Medical Care, Humacyte ink $150m strategic partnership deal
Fresenius Medical Care (NYSE:FMS; ETR:FRE) said today it inked a $150 million strategic partnership deal with Humacyte through which Fresenius will gain exclusive rights to commercialize Humacyte’s Humacyl bioengineered blood vessel technology. Research Triangle Park, N.C.-based Humacyte is exploring the use of its Humacyl human acellular vessel as a conduit for hemodialysis in patients with end-stage renal […]
Baxter touts Theranova HDx dialysis tech study data
Baxter (NYSE:BAX) today released new data from studies exploring expanded hemodialysis with its Theranova dialyzer, touting the device’s ability to clear large middle molecules at a higher rate than standard hemodialysis and equal or faster removal rates compared to high-volume hemodiafiltration. Results from a number of studies and poster presentations on the Theranova dialyzer were presented […]
T2 Biosystems wins FDA nod for T2 Bacteria panel, plans offering
T2 Biosystems today announced it won FDA clearance for its T2 Bacteria panel for detecting bacterial species in human blood from patients with suspected bloodstream infections, and announced plans for an upcoming offering. The Lexington, Mass.-based company said that it won approval for the detection of specific sepsis-causing bacterial pathogens as acquired from a whole […]
Saranas raises $3m in Series C to support Early Bird bleed monitor
Internal bleeding detection device developer Saranas said today it raised $2.8 million in a Series C funding round slated to support its Early Bird bleeding monitor system. The Early bird device is designed as a standard vascular access sheath which is embedded with sensors which detect bleeding from accidentally ruptured blood vessels during cardiac procedures, including transcatheter […]
EuroPCR 2018 Roundup: Medtronic touts BP reductions, no major adverse events in renal denervation trial
Medtronic (NYSE:MDT) today released six-month results from a trial of its Symplicity Spyral renal denervation system exploring its use treating hypertensive patients who are already taking anti-hypertension medications, touting significant reductions in blood pressure and no major adverse safety events. Results were presented at the 2018 EuroPCR annual meeting in Paris and were published in The […]
Report: Google’s Verily developing painless blood draw device
Google (NSDQ:GOOG) parent Alphabet‘s (NSDQ:GOOGL) Verily is developing a painless blood collection system using microneedles and magnets, according to a new CNBC report. The system has already been implemented in a working prototype by Verily’s Silicon Valley team, though the company is exploring multiple form factors for the device, according to the report. Commercialization of the moonshot device, which […]
Cook Medical wins FDA de novo nod for Hemospray
Cook Medical said yesterday it won FDA de novo clearance for its Hemospray endoscopic hemostat designed for treating bleeding in the gastrointestinal tract. The Hemospray product won indications from the FDA for treating non-variceal GI bleeds, the Bloomington, Ind.-based company said. Hemospray is a single-use device designed to deliver an aerosolized spray of a mineral blend […]
Haemonetics swings to black for fiscal Q4, 2018
Haemonetics (NYSE:HAE) eked out a sales-and-earnings beat with its fiscal fourth-quarter and 2018 numbers today, posting swings to black ink for both periods. The Braintree, Mass.-based blood management company reported profits of $11.9 million, or 22¢ per share, on sales of $233.6 million for the three months ended March 31, compared with losses of -$51.1 million […]