Haemonetics (NYSE:HAE) announced that it acquired next-generation whole blood coagulation testing system developer Enicor GmbH for an undisclosed amount. Munich, Germany-based Enicor develops the ClotPro system designed for viscoelastic diagnostics touted to offer more assays than any other hemostasis analyzer on the market. Haemonetics said in a news release that ClotPro is set to be coupled […]
CHF Solutions increases production staff for Aquadex Smartflow due to COVID-19
CHF Solutions (NSDQ:CHFS) announced today that it is increasing the production staff that assembles its next-generation Aquadex SmartFlow consoles after increased demand from hospitals as a result of the COVID-19 pandemic. The Aquadex SmartFlow system is designed to remove excess fluid from patients suffering from hypervolemia (fluid overload). It is indicated for temporary (up to eight […]
FDA clears Siemens Healthineers blood analyzer
Siemens Healthineers (ETR: SHL) announced today that it won FDA clearance for its RapidPoint 500e blood gas analyzer for diagnosing and monitoring people in the intensive care unit, operating room or emergency room. RapidPoint 500e is designed to generate blood gas, electrolyte, metabolite, CO-oximetry and neonatal bilirubin results that are then used to diagnose and […]
CHF Solutions prices $2.2m offering
CHF Solutions (NSDQ:CHFS) announced today that it priced a registered direct offering of common stock worth approximately $2.2 million. The Eden Prairie, Minn.-based ultrafiltration therapy developer is offering more than 5.1 million shares of its common stock at a public price of approximately 43¢ per share. CHF Solutions expects gross proceeds of $2,226,000 prior to the […]
Smiths Medical warns on LogiCal blood sampling system sets
Smiths Medical issued an urgent field safety notice to warn of corrective action for its LogiCal 5 ml closed blood sampling system sets and HemoDraw Plus closed blood sampling sets with the LogiCal pressure monitoring system. The company said in the notice out of Germany that it became aware that customers using the LogiCal and […]
BD recalls hundreds of thousands of Alaris pumps due to multiple issues
The FDA today warned on a Class I recall of Becton Dickinson (NYSE:BDX) Alaris system infusion pumps due to multiple system errors, software errors, and use-related errors. All lots of five different models of the Alaris system were included in the recall that Becton Dickinson initiated on Feb. 4. In total, the company recalled 774,000 devices […]
CHF Solutions wins FDA nod for Aquadex SmartFlow pediatric indication
CHF Solutions (NSDQ:CHFS) announced today that it received FDA 510(k) clearance for its next-generation Aquadex SmartFlow console for use in adult and pediatric patients weighing 20 kg or more. Eden Prairie, Minn.–based CHF Solutions said it submitted an application for clearance for the next-generation console last month, having previously offered its Aquadex FlexFlow system that wasn’t […]
Fist Assist announces CE Mark and European launch
Fist Assist Devices recently announced that it received CE Mark approval for its Fist Assist device for vein enhancement and enlargement. Los Altos Hills, Calif.-based Fist Assist Devices said it has begun commercialization and marketing of the device in the European Union. The Fist Assist device is a non-invasive external platform designed to utilize a […]
CHF Solutions secures distribution arrangement in central Europe
CHF Solutions (NSDQ:CHFS) announced today that it initiated distribution agreements with Neucomed Group and its affiliates to cover Germany, Austria and Switzerland. With the new distribution agreements, Eden Prairie, Minn.–based CHF Solutions is further expanding its commercial presence in Europe, as the company now has distribution partnerships covering 13 different countries across the globe, according to […]
Laminate Medical completes enrollment in U.S. pivotal trial
Laminate Medical Technologies announced that it completed enrollment into its VasQ external support U.S. pivotal study of patients in need of an arteriovenous fistula (AVF) for hemodialysis. The study prospectively enrolled 144 male and female patients, both brachiocephalic and radiocephalic AVF patients, across 17 sites in the U.S. They are slated to be followed for […]
Thrombolex raises $9.8m for its endovascular catheters
Thrombolex filed an amendment to its SEC Form D to reveal that the company sold nearly $10 million in a debt offering. The New Britain, Pa.-based company made the first sale in the offering of debt and convertible promissory notes on April 6, 2017. No issuer size was disclosed for the offering, which included contributions […]
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