Sunshine Heart has completed two-year follow-up mark for first patient who was implanted with the C-Pulse Heart Assist System in the North America feasibility trial. According to the results from the first patient, it was observed that ...
Tags: Sunshine Heart, two-year follow-up mark, C-Pulse system
BioControl Medical is set to commence the second phase of its INcrease Of VAgal TonE in Heart Failure (INOVATE-HF) study, following the US Food and Drug Administration (FDA) approval. The CardioFit system, which comprises a stimulator, a ...
Tags: BioControl Medical, INcrease Of VAgal TonE in Heart Failure study
Critical Diagnostics has chosen quality distributors to expand the availability of its cardiac biomarker, Presage ST2 assay, in Europe. Quality distributors include Bestbion company, who is responsible for distributing the cardiac ...
CardioKinetix has obtained CE mark approval for its full size matrix of its percutaneous ventricular restoration device to treat patients with ischemic heart failure. The Parachute ventricular partitioning device uses a small catheter ...
Tags: CE Mark, heart failure, medical device
Abiomed has received US Food and Drug Administration's (FDA) investigational device exemption (IDE) to begin a pivotal clinical study of its Impella Right-side Percutaneous (RP ) pump. The percutaneous heart pump is implanted through a ...
Tags: percutaneous heart pump, Impella Right-side Percutaneous pump, FDA
Arizona-based PCI Nuclear Pharmacy, a provider of unit dose radiopharmaceuticals and ancillary products used in nuclear medicine, has acquired Daxor's BVA-100 blood volume analyzer. BVA-100 instrument, which is used in conjunction with ...
Tags: blood volume analyzer, radiopharmaceuticals, ancillary products
BioCardia has announced positive results from a Phase I/II trial of its Helical Infusion system, designed to deliver donor's (allogeneic) or treated patient's (autologous) adult mesenchymal stem cells (MSCs) via transendocardial stem cell ...
Tags: Helical Infusion system, stem cell injection, device, Infusion System
Roche is planning to invest CHF240m ($259m) to construct a new diagnostics production facility at its Penzberg biotechnology center in Munich, Germany. The new 26,000ft2 plant, which will be known as Diagnostics Operations Complex II ...
The Japan's Ministry of Health, Labour and Welfare has approved Thoratec's HeartMate II for use as a Bridge-to-Transplantation therapy for patients with advanced heart failure. The approval was based on a confirmatory clinical study, ...
Tags: Japan, health, therapy, heart failure
BG Medicine has registered a 510(k) premarket notification with the US Food and Drug Administration (FDA) for approval of its Architect Galectin-3 assay. The Architect Galectin-3 assay, which is designed for use with Abbott's automated ...
Tags: BG Medicine, premarket notification, FDA, Architect Galectin-3 assay
The US Food and Drug Administration (FDA) has granted approval to HeartWare International's miniaturized ventricular assist system. The HeartWare system, which includes a HVAD circulatory assist device with a sintered inflow cannula, ...
Tags: ventricular assist system, cardiac transplantation, FDA
RegeneRx Biopharmaceuticals has received an issued patent in Mexico and allowances of three additional patent applications in Mexico and Israel, related to Thymosin beta 4 (Tβ4). The patents are set to expire 2024-2026, the ...
Mylan Pharmaceuticals has won final FDA approval for its abbreviated new drug application (ANDA) of Itraconazole capsules, 100mg, the generic version of Janssen Pharmaceutical's Sporanox capsules. The generic Sporanox is indicated for the ...
BG Medicine has filed 510(k) premarket notification for regulatory clearance of an expanded indication for its BGM Galectin-3 test with the FDA. The blood test is at present indicated for use in patients with chronic heart failure who are ...
Tags: BG Medicine, blood test, heart failure
Cardiovascular diagnostics developer BG Medicine has filed a 510(k) Premarket Notification with the US Food and Drug Administration (FDA) for regulatory clearance for the ARCHITECT Galectin-3 assay. Used with Abbott's fully automated ...