Nephros (OTC:NEPH) said today it won FDA 510(k) clearance for its EndoPur 10″ endotoxin filter designed for dialysis systems. The River Edge, N.J.-based company said the newly cleared EndoPur 10″ filter is designed to produce hemodialysis quality water for dialysis systems, and fits into existing filter cartridge housings. Nephros touted the device as having the smallest […]
Baxter (NYSE:BAX) announced earlier this month it tapped former Medtronic (NYSE:MDT) senior VP of medicine and tech Stephen Oesterle for its board of directors, bringing the total seats on the board to 12. Oesterle moved to the venture capital firm New Enterprise Associates last Sept from his position at Medtronic. Before moving to NEA, Oesterle served […]
Nephros (OTC:NEPH) said today it won FDA 510(k) clearance for its water ionizer review designed for water bacterial filtration. The River Edge, N.J.-based company said its HydraGuard 10″ UltraFilter is designed to provide 6 months of bacterial protection and filtration for potable water sources such as endoscope re-processors, surgical humidifiers and ice machines. “The HydraGuard is a […]
Nephros (OTC:NEPH) said today it signed a distribution agreement with CS Medical to distribute Nephros’ DSU-H ultrafilter as an option with CS Medical’s TD 100 automated trans-esophageal echocardiogram probe disinfector. The DSU-H filter from Nephros has FDA 510(k) clearance and is designed to provide ultrapure water as an aid in infection prevention and control, CS Medical […]
Nephros (OTC:NEPH) said last week it received a notice from the FDA closing out a warning letter the company received last May concerning issues with the manufacturing of a variety of its filtration systems. The warning from the federal watchdog to River Edge, N.J.-based Nephros included warnings on a failure to document and evaluate potential suppliers and […]
MannKind Corporation said last week it picked up ex-Insulet (NSDQ:PODD) CEO Duane DeSisto as its new prez and CEO, effective January 5, 2016. DeSisto will replace interim CEO Alfred Mann, who has held the spot since November. DeSisto will also join the company’s board of directors, according to a press release from the Valencia, Calif.-based company. […]
NeuSpera Medical said it snagged the former R&D senior vice president at Cyberonics, Milton Morris, for its corner office as it gears up to raise a Series A round for its neuromodulation technology. NeuSpera, formerly known as Vivonda Medical, is developing injectable neuromodulation devices, so called “electroceuticals,” using licensed mid-field powering technology. The Santa Clara, […]
Mirandola-based Bellco is focused on providing dialysis and extracorporeal blood purification technology. The 2 companies have extended their deal until Dec. 31, 2021, according to a press release.