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.

An artificial intelligence (AI) algorithm developed by Geisinger researchers that uses echocardiogram videos predicted all-cause mortality at one year more accurately than three out of four expert cardiologists and other predictors commonly used in clinical practice, a study in Nature Biomedical Engineering demonstrated.

The U.S. FDA has granted breakthrough device designation to Cerus Endovascular Ltd. for its Contour neurovascular system for the treatment of intracranial aneurysms. The company is targeting the second or third quarter of this year for the start of its IDE clinical trial.

PARIS – Four years after being set up in Marseilles, France, Volta Medical SAS reported raising $28 million in a series A round for the VX1 software mapping system, an artificial intelligence (AI) algorithm that is compatible with most readily available multipolar catheters and technology used in operating rooms and cath labs to treat cardiac arrhythmia.

Novasignal Corp. has a launched a cloud-based app to provide alerts to clinicians directly from its cerebral ultrasound device. The new app allows physicians to get instant notifications from the company’s Novaguide device, a transcranial doppler ultrasound technology that allows for real-time assessment of blood flow in the brain by combining robotics and artificial intelligence (AI).

Chinese heart valve specialist Microport Cardioflow Medtech Corp. (HKEX:2160) launched an IPO in Hong Kong on Feb. 4, raising HK$2.5 billion (US$324 million) by issuing 205.62 million shares at HK$12.20 apiece. With J.P. Morgan, Citi and CICC backing the IPO, the stock opened at HK$21.50, up 76% from the offer price. The pre-revenue med-tech firm, spun off from Microport Scientific Corp. in 2020, develops transcatheter aortic valve implantation (TAVI) products for valvular heart diseases, and is especially known for its Vitaflow series.

Biosig Technologies Inc. and the Mayo Foundation for Medical Education and Research are jointly developing next-generation artificial intelligence (AI)-powered software for Biosig’s Pure EP electrocardiograph system. The Pure EP system acquires, measures, calculates and stores electrocardiographic and intracardiac signals for patients during electrophysiology procedures. The collaboration aims to expand the captured signals and combine them with other data sources to provide more actionable information.

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.