News Briefs

FDA Grants Breakthrough Designation for KidneyIntelX™ The US FDA has granted the designation Breakthrough Device to RenalytixAI for its lead diagnostic KidneyIntelX™. According to a press release from RenalytixAI, this is the first such designation for an AI-enabled diagnostic tool for kidney disease announced by any company. In an effort to curtail the estimated $114 billion annual cost of chronic ... Read More »

Supplemental New Drug Application for INVOKANA® Submitted Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration seeking a new indication for INVOKANA® to reduce the risk of end-stage renal disease, the doubling of serum creatinine, and renal or cardiovascular death in adults with type 2 diabetes and ... Read More »

WavelinQ™ 4F EndoAVF System Receives 510(k) Clearance from FDA In February, BD (Becton, Dickinson and Company), a global medical technology company, received 510(k) clearance from the US Food and Drug Administration for the BD WavelinQ™ 4 French (4F) endoAVF system. The system is a recent innovation in endovascular arteriovenous fistula (endoAVF) creation technology; it allows for the creation of an ... Read More »

In a recent press release, RenalytixAI announced the initiation of its clinical validation study for KidneyIntelX™. RenalytixAI develops artificial intelligence-enabled diagnostics for kidney disease. KidneyIntelX is designed to diagnose and improve clinical management of patients with type 2 diabetes and those of African ancestry with fast-progressing kidney disease. The expanded validation study program includes investigators from Johns Hopkins Medicine, Emory ... Read More »

RenalytixAI, a developer of artificial intelligence-enabled clinical diagnostics for kidney disease, has raised $29 million to support the development and commercialization of two product categories for the early detection of kidney disease and accurate management of kidney transplant rejection. The launch of the first product, KidneyIntelX™, is planned for 2019; the launch will be conducted in collaboration with the Icahn ... Read More »

The RAND Corporation has released results from a recent analysis demonstrating that providing specialized medical care and coordination in patients with reduced kidney function prior to the need for dialysis treatment could save the US health care system more than $1 billion each year. According to a press release from the RAND corporation, approximately 60% of the savings would be ... Read More »

Fresenius Awards $100,000 Grant to ANNA in Celebration of Nephrology Nurses Week   In recognition of the 50th anniversary year of the American Nephrology Nurses Association (ANNA) and in honor of Nephrology Nurses Week, September 9-15, Fresenius Medical Care North America has awarded ANNA a $100,000 grant. According to a press release from Fresenius Medical Care North America, the award ... Read More »

Study 206 Begins Treatment of Patients with ALLN-177 for Hyperoxaluria Allena Pharmaceuticals, Inc., a late-stage biopharmaceutical company specializing in oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, has announced that the first patients have been enrolled and are being treated in a phase 2 basket study of ALLN-177. According to a press release, Study ... Read More »

Lori Neal and Kevin Harris Named to NNCC Board of Commissioners Lori Neal, BSN, RN, CNN, and Kevin Harris have been appointed to the Board of Commissioners of the Nephrology Nursing Certification Commission (NNCC). In a June press release, NNCC announced that Ms. Neal and Mr. Harris will serve 2-year terms. Ms. Neal is a clinical support specialist for Fresenius ... Read More »

Relypsa Research Grants Awarded to Three Institutions In a press release in April, Relypsa, a Vifor Pharma Group company, announced the presentation of three research grants to supplement institutional funding for nephrology and/or cardiology fellows who are researching hyperkalemia and other disorders. Alain Romero, PhD, PharmD, Relypsa vice president of medical and scientific affairs, said, “Our research grants aim to ... Read More »