Outset Medical (NSDQ:OM) announced today that it appointed Jean-Olivier Racine as its new chief technology officer. Racine, a veteran of more than two decades in the technology industry, previously worked as the head of engineering and science for Amazon Web Services (AWS) Health AI, where he managed Amazon Comprehend Medical, Amazon HealthLake and more health […]
Blood Management
VoluMetrix’s venous waveform monitor wins FDA breakthrough designation
VoluMetrix announced today that it received FDA breakthrough device designation for its NIVA HF venous waveform monitor. Nashville, Tenn.–based VoluMetrix designed the investigational NIVA HF device to monitor the venous waveform, a novel physiologic signal in heart failure patients, through its non-invasive venous waveform analysis (NIVA) technology. According to a news release, a fast-track grant […]
Apple Watch may someday detect blood sugar, blood pressure levels
Rockley Photonics indicated in an SEC filing that it may work with Apple in the future to introduce new monitoring functions to the Apple Watch. The Telegraph first reported on the filing, which indicated that the company’s operating financial results will depend on revenue that is attributable to a few of its large customers, including […]
Vascular Therapies touts surgical stenosis treatment trial despite missed primary endpoint
Vascular Therapies announced today that a Phase 3 clinical trial of its Sirogen sirolimus formulation showed encouraging outcomes. Cresskill, N.J.-based Vascular Therapies designed its Sirogen proprietary sirolimus formulation for intraoperative local drug delivery to reduce surgical stenosis in blood vessels. The Phase 3 clinical trial evaluated Sirogen in elderly end-stage renal disease patients, according to a […]
CHF Solutions changes name, broadens focus
CHF Solutions announced that it has changed its name to Nuwellis to reflect its focus on pediatric care, critical care and heart failure fluid imbalance. Eden Prairie, Minn.–based Nuwellis made the change effective on Tuesday, April 27, 2021, and, in conjunction with the name change, changed its ticker symbol on the Nasdaq from CHFS to […]
Abbott Xience stent gains expanded CE mark
Abbott (NYSE:ABT) announced today that its Xience stent received CE mark approval for a shorter duration of dual anti-platelet therapy (DAPT). The European approval for the stent allows for the DAPT to go as short as 28 days, the shortest indication available in the world for patients with high bleeding risk (HBR), according to a news […]
Medtronic recalls oxygenator used for cardiopulmonary bypass among kids
The FDA has designated a recall of a Medtronic oxygenator used on kids as Class I, its most serious level. The Affinity Pixie oxygenator and cardiotomy/venous reservoir with Balance biosurface is designed for treating newborns, infants and small pediatric patients requiring cardiopulmonary bypass. The system adds oxygen to the blood and removes carbon dioxide, while the […]
Racial disparities remain despite increased mechanical clot removal in stroke patients
Data presented at the American Stroke Association’s International Stroke Conference 2021 shows that racial disparities persist in stroke treatment. According to a news release, mechanical removal of blood clots causing a stroke is increasing, but there remain racial differences in the treatment, a study shows. Get the full story at our sister site, Medical Design […]
CHF Solutions prices $18.1M offering
CHF Solutions (NSDQ:CHFS) announced today that it priced an underwritten public offering of common stock worth $18.1 million. Eden Prairie, Minn.-based CHF Solutions is offering more than 3.3 million shares of its common stock to the public at $5.50 per share, totaling the $18.1 million expected in proceeds before deducting underwriting discounts and commissions and offering […]
Military blood transfuion set recall is serious
The FDA last week announced a Class I recall — the most serious kind — for transfusion sets made by Combat Medical Systems. Included in the recall was the Valkyrie LTOWB Collection and Administration set, Low Titer Type O Transfusion Set and Low Titer Type O Donor Collection Set and the Fresh Whole Blood Transfusion […]
FDA approves EndoClot hemostat for GI bleeding
EndoClot Plus this week announced that it has received FDA approval for its EndoClot Polysaccharide Hemostatic System (PHS). EndoClot PHS is a nonthermal, nontraumatic method for achieving hemostasis with GI bleeds and is designed to help gastroenterologists stop bleeding rapidly and reliably. The single-use device has a starch-based powder hemostat that is applied directly to […]
