The FDA has granted Sterilucent emergency use authorization (EUA) for its hydrogen peroxide sterilizer for use with N95 and N95-equivalent respirators — the latest in a string of mask sterilizers receiving EUAs amid the coronavirus pandemic. Minneapolis-based Sterilucent’s HC 80TT vaporized hydrogen peroxide sterilizer may now be used to decontaminate the single-use compatible respirators that […]
Latest pandemic-related shortages: Dialysis machines & supplies
Medtech manufacturers have begun responding to some unexpected shortages brought on by the coronavirus pandemic. Demand for kidney dialysis equipment and supplies has jumped in hospitals in COVID-19 hot spots, leading to spot shortages and taking healthcare providers by surprise, as they considered the virus a respiratory disease. Get the full story on our sister […]
Fresenius to launch a mechanical ventilators alternative in U.S.
Fresenius (NYSE:FMS) announced today that it has achieved a 510(k) clearance for its Novalung system — which reduces or eliminates the need for mechanical ventilation by pumping a person’s blood through an oxygenator for gas exchange. Fresenius boasted that the Novalung is the first extracorporeal membrane oxygenation (ECMO) system cleared to provide more than six hours […]
Fresenius Medical Care North America launches connected health platform
Fresenius (NYSE:FMS) recently announced that its Fresenius Medical Care North America (FMCNA) business has launched a connected health platform called TheHub. TheHub includes three integrated applications meant to enable people on dialysis, their care teams, and health providers to better collaborate. Fresenius officials see the system enhancing remote monitoring for people on home dialysis. The Trump administration […]
Fresenius Medical Care wins FDA breakthrough nod for clot-preventing dialysis device
Fresenius Medical Care North America (NYSE:FMS) said today that it won breakthrough device designation from the FDA for the new hemodialysis system it’s developing. Waltham, Mass.-based Fresenius said its Endexo antithrombogenic additive is being incorporated into the manufacturing of dialyzers and bloodlines. The device is a polymer made of modifying molecules designed to inhibit the adsorption […]
Report: Fresenius to shutter Ohio billing operation, lay off 57
Fresenius Management Services (NYSE:FMS; ETR:FRE) is reportedly closing its medical billing facility and laying off nearly 60 employees in North Olmsted, Ohio. The company filed a Worker Adjustment and Retraining Notification on Oct. 4 saying that it would lay off 56 employees on December 6 and add one more employee to the layoffs on Jan. […]
The 10 largest medical device companies in the world
The merger of the French lens manufacturer Essilor with Italian eyewear maker Luxottica boosted the new EssilorLuxottica into the top 10 of the Big 100 list of largest medical device companies in the world — produced by our sister site Medical Design & Outsourcing. Overall, consolidation continues to play a major role in shaping the […]
Dynatronics promotes COO Baker to replace von Jako as CEO | Personnel Moves, August 30, 2019
After deciding this week that its CEO needs to be based in Eagan, Minn., and with chief executive Chris von Jako unwilling to relocate his family, Dynatronics (NSDQ:DYNT) promoted COO Brian Baker to the corner office, effective August 28. “After thoughtful consideration, the board of directors determined that the company’s CEO needs to be based in […]
Trump reveals plan to overhaul kidney disease care
The Trump administration yesterday revealed its plan to overhaul the way kidney disease is treated in the U.S., looking to increase early detection and emphasize transplants and home hemodialysis instead of in-clinic treatment via executive order. Shares of dialysis providers DaVita Healthcare (NYSE:DVA) and Fresenius (NYSE:FMS) took a hit earlier this week on news of the changes. The executive […]
DaVita, Fresenius slide on Trump threat to overhaul dialysis market
Shares of dialysis providers DaVita Healthcare (NYSE:DVA) and Fresenius (NYSE:FMS) took a hit today after a report surfaced that the Trump administration is readying an overhaul of the kidney treatment market. The president plans to issue an executive order tomorrow that would seek to incentivize kidney transplants and home hemodialysis in a bid to lower the […]
Fresenius invests in BioIntelliSense
Fresenius Medical Care (NYSE:FMS; ETR:FRE) today announced an investment in BioIntelliSense for an undisclosed amount. Denver-based BioIntelliSense is developing a medical-grade data services platform for continuous remote health monitoring, predictive analytics and algorithmic clinical insights. Through the agreement, Fresenius will use the advanced analytics and artificial intelligence to develop medical wearables for clinical pathways that allow […]
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