FDA breakthrough status gives Coredio’s AI heart failure platform a faster regulatory path
Coredio’s AI heart failure platform may bring hemodynamic insight into home care. See why FDA breakthrough status matters now.
Can United Therapeutics turn pig-heart xenotransplantation into a regulated clinical pathway?
A pig-heart trial is no longer just a scientific leap. United Therapeutics now faces the harder test of safety, scale, and regulation.
Can Alnylam’s AMVUTTRA become a first-line treatment force in ATTR-CM?
ATTR-CM treatment is shifting earlier. Alnylam must now prove AMVUTTRA can win clinician trust beyond trial subgroups.
Can Reprieve Cardiovascular’s FASTR data change acute heart failure decongestion?
Heart failure care needs faster decongestion without kidney harm. Reprieve’s FASTR data now face the pivotal trial test.
Can Lasix ONYU move heart failure edema care from hospital infusion to home treatment?
Heart failure care needs fewer hospital stays. Lasix ONYU now tests whether Europe is ready for at-home subcutaneous diuresis.
Medtronic backs Pulnovo Medical in $100m round to expand PADN in pulmonary hypertension
Pulnovo Medical raised $100 million with Medtronic backing. Read what it means for PADN, pulmonary hypertension, heart failure, and device markets.
Can Lupin Limited gain ground in cardiometabolic generics with United States dapagliflozin launch?
Lupin Limited has launched generic dapagliflozin in the United States. Read what it means for Farxiga, pricing pressure, and market access.
Can negative pressure therapy disrupt renal support in heart failure? Inside JuxtaFlow’s new approach
Roivios Ltd., a clinical-stage medical device developer focused on kidney health, has reported promising results from its first-in-human trial of the JuxtaFlow Renal Assist Device. This investigational system applies controlled negative pressure to the renal pelvis to enhance urine output and sodium excretion in patients with diuretic-resistant cardiorenal syndrome and acute decompensated heart failure. While […]
Can Roivios’ JuxtaFlow device redefine kidney support in heart failure and cardiac surgery patients?
Roivios Ltd., a clinical-stage medical device developer, has announced encouraging results from its first-in-human study of the JuxtaFlow Renal Assist Device, a technology designed to support fluid removal and renal function in patients with diuretic-resistant cardiorenal syndrome and acute decompensated heart failure. The results, published in the ASAIO Journal, showed that JuxtaFlow significantly improved both […]
Will the TricValve pivotal trial finally solve the unmet needs in severe tricuspid regurgitation?
P&F Products and Features GmbH, the Austria-based cardiovascular device innovator, has secured approval from the U.S. Food and Drug Administration to initiate the TRICAV II pivotal clinical trial. The study will evaluate the TricValve Transcatheter Bicaval Valve System for severe tricuspid regurgitation, aiming to provide a minimally invasive option for patients who currently have no […]