The FDA yesterday granted de novo clearance to a Medtronic (NYSE:MDT) device designed to provide continuous dialysis in critically ill young children. The Carpediem extracorporeal blood-filtration system was designed to provide continuous renal replacement therapy (CRRT) to critically ill patients weighing 5.5 to 22 lb. These patients must have a sudden or temporary loss of kidney […]
Dialysis
Baxter granted FDA EUA for Oxiris blood purification filter in COVID-19 treatment
Baxter (NYSE:BAX) announced that it received FDA emergency use authorization (EUA) for use of its Oxiris filter in treating COVID-19 patients. The authorization is for the use of Oxiris in patients admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure that are in need of blood purification therapy to reduce pro-inflammatory cytokine […]
Baxter hiring thousands to boost COVID-19 supply output
Baxter (NYSE:BAX) told investors today that it is looking to hire 2,000 permanent and temporary workers — including 800 in the U.S. — to produce more supplies needed to treat coronavirus patients. In a document related to its upcoming annual meeting, scheduled for May 5, 2020, the company said increased demand for its products spurred the […]
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 […]
Merit Medical wins FDA breakthrough nods
Merit Medical (NSDQ:MMSI) systems announced that it won two additional breakthrough device designations from the FDA for its Wrapsody endovascular stent graft system. Wrapsody is designed as a flexible, self-expanding endoprosthesis and won a breakthrough nod in November 2019 for hemodialysis treatment. Its latest indications include treating stenosis or occlusion within the dialysis outflow circuit, including […]
Outset Medical at-home dialysis system wins FDA approval
Outset Medical announced that it won expanded FDA clearance for patient use in the home with its Tablo hemodialysis system. Tablo’s existing indication included use in acute and chronic care facilities but, amid the COVID-19 pandemic, can now offer hemodialysis treatment from the home as in-hospital treatment is more of a challenge under current circumstances. […]
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 […]
CloudCath raises $12m for at-home dialysis monitoring software
CloudCath announced today that it completed a $12 million Series A financing round for its at-home dialysis monitoring treatment platform. San Francisco–based CloudCath’s system, which is its first product, is designed to enable remote, real-time monitoring for people undergoing at-home peritoneal dialysis to allow for earlier complication intervention. Proceeds from the funding round are also […]
Bluegrass Vascular Technologies wins de novo nod for ‘inside-out’ vascular access catheter
Bluegrass Vascular Technologies announced that it won FDA de novo clearance for its Surfacer inside-out access catheter system. The Surfacer is designed to obtain central venous access through its inside-out approach, facilitating catheter insertion to the central venous system in people with upper body venous occlusions or other conditions that limit central venous access through […]
Outset Medical raises $125m for its all-in-one dialysis system
Outset Medical has raised $125 million in a Series E equity financing round that will help support the commercial expansion of the Tablo hemodialysis system in the U.S. D1 Capital Partners led the round, with Fidelity Management and Research C., Partner Fund Management, Perceptive Advisors, and funds advised by T. Rowe Price Associates also participating. […]
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 […]