TORONTO – Puzzle Medical Devices Inc. has been granted a U.S. FDA breakthrough device designation for a transcatheter heart pump designed for fragile patients with few minimally invasive options for treating advanced heart failure.

Last year, artificial intelligence (AI)-focused Caption Health Inc. won the U.S. FDA’s nod for software that guides untrained clinicians step-by-step in providing a cardiac ultrasound exam, a process normally performed by a highly skilled specialist. Now, the Brisbane, Calif.-based company has published data showing nurses without prior ultrasound experience who used Caption Guidance software captured ultrasound images of diagnostic quality to assess known cardiac conditions.

Cardiac monitoring company Rhythmedix Inc. reported the launch of its next-generation, wearable Rhythmstar device with built-in 4G cellular connectivity. The low-profile, water-resistant cardiac telemetry monitor provides extended remote monitoring to quickly detect arrhythmia without the need for a phone or other communication device.

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.

HONG KONG – Rsip Vision Ltd. have developed a new coronary artery segmentation tool based on deep learning technology that should allow for faster 3D models of coronary artery anatomy and facilitate precise measurements of artery length and diameter.

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.