A U.S. FDA advisory committee voted 14 nays to three ayes that the benefits of the Lutonix 014 drug-coated balloon (DCB) do not outweigh the risks in a panel proceeding peppered by problems with missing data and a lack of operator blinding. The panel widely saw the use of paclitaxel-eluting technologies in other areas of the vasculature as a reassurance that this device might perform as promised, but the outcome nonetheless leaves the sponsor with a new round of negotiations with the FDA as to how to move forward.

Cardiacsense Ltd.’s medical watch received CE mark for the detection of atrial fibrillation and heart rate variability monitoring. The watch provides continuous, long-term monitoring of heart arrhythmias without cumbersome external devices or invasive implants. The European clearance does not require a prescription for use and will enable the Caesarea, Israel-based company to begin distribution under a number of agreements the company signed in 2020.

TORONTO – Soundbite Medical Solutions Inc. has received Health Canada approval for a shock wave device that jackhammers its way through calcified, chronic total occlusions (CTO) in life-threatening critical limb ischemia (CLI), a severe form of peripheral artery disease. This comes after the Active Wire 0.014” was used for the first time in late January to successfully treat five patients.

Shockwave Medical Inc. said Tuesday that its intravascular lithotripsy (IVL) therapy has won U.S. FDA approval for the treatment of severe coronary artery disease (CAD). The technology, which was granted breakthrough device designation in 2019, is a novel application of lithotripsy, which has long been used to safely shatter kidney stones.