Spectrawave Inc. has scooped up $13.2 million in a series A-2 financing led by prior investor Deerfield Management. The funds will be used to complete development and regulatory filing for its flagship cardiac imaging technology. Prior unnamed seed investors also participated in the round. With this latest infusion, Spectrawave has raised a total of approximately $30 million to date.

TORONTO – Kardium Inc. has secured US$115 million in private money to accelerate commercial growth in Europe of a mapping and ablation system for atrial fibrillation (AF), and conduct a clinical study for FDA approval of the system. Led by Fidelity Management & Research Co. LLC, this funding tranche follows a US$40 million investment in Kardium in 2018 driven by T. Rowe Price Associates Inc., which also invested this time around.

Medtronic plc received U.S. FDA premarket approval of its Diamondtemp Ablation (DTA) system for treatment of patients with recurrent, symptomatic paroxysmal atrial fibrillation. The temperature-controlled radiofrequency (RF) ablation system features industrial-grade diamonds, which provide 200 to 400 times the thermal conductivity seen in conventional ablation and enable more efficient delivery of energy to regions of the heart responsible for the erratic electrical signals underlying atrial fibrillation (AF).

Using Rhythm AI Ltd.'s stochastic trajectory analysis of ranked signals (STAR) mapping system with pulmonary vein isolation terminated and eliminated recurrence of persistent atrial fibrillation (AF) at much higher rates than other ablation procedures in a study published in the Journal of Cardiovascular Electrophysiology. The artificial intelligence-driven STAR mapping process collects and analyzes thousands of heart signals to precisely identify the areas of the heart responsible for the errant electrical signals causing atrial fibrillation, enabling more thorough and accurate ablation.

TORONTO – Calgary-based Circle Cardiovascular Imaging Inc. is receiving CA$2.65 million (US$2.09 million) in funding from the Canadian government’s Western Diversification Program (WDP), which represents nearly half of the more than CA$5.5 million (US$3.35 million) investment made to four Alberta-based organizations and companies. Company CEO Greg Ogrodnick attributes this to Circle Cardiovascular’s position “as the world leader in cardiovascular imaging.”

The storm of controversy over the use of paclitaxel in devices for the peripheral vasculature had a dramatic effect on utilization, but a new study coming out of Sweden seems to have helped further ease concerns about purported mortality associated with this antiproliferative. While this unplanned interim analysis lends yet more support to the view that the mortality signal in the so-called Katsanos paper did not reflect a true biological finding, the net effect of the controversy has prompted a call for a registry that might eliminate some statistical noise that had a significant and harmful impact on patients.

The U.S. Centers for Medicare & Medicaid Services (CMS) issued a final version of a proposed rewrite of the national coverage determination (NCD) for mitral valve repair devices that includes a coverage with evidence development (CED) mandate. The final also retains the draft’s provisions for secondary mitral valve regurgitation, which analysts say will double or even triple the market for devices thus approved by the FDA.