Receipt of EU MDR CE mark may not be a magic potion, but Elixir Medical Corp. is certainly feeling a boost from the regulatory nod for its mechanical Lithix hertz contact intravascular lithotripsy system for treatment of moderate to severely calcified coronary artery lesions. Simultaneously, the company reported the launch of Lithix and completion of first cases in Italy, France and Germany.

A 1,000-person study using Heartflow Inc. technology demonstrated that findings of coronary plaque on heart CT scans could indicate which patients were at risk of cardiovascular events up to seven years in the future – potentially providing a road map toward screening for heart disease, the leading cause of death for both men and women in the U.S. and worldwide.

Two recent trials in cardiovascular disease took critical steps toward addressing ongoing and deadly disparities in cardiac care by focusing entirely on women.

GE Healthcare Technologies Inc. received U.S. FDA approval for its novel radiotracer, Flyrcado (flurpiridaz F-18), for use in the diagnosis of myocardial ischemia or infarction in patients with known or suspected coronary artery disease.

Boston Scientific Corp. continued its journey down the acquisition highway with its announced plan to acquire stroke products maker Silk Road Medical Inc. for $27.50 a share, or approximately $1.16 billion.

Heartflow Inc. reported exceptional results in a study published in the Journal of Vascular Surgery that revealed coronary computed tomography angiography with fractional flow reserve care reduced mortality by more than 60% at five years in patients with peripheral arterial disease undergoing major vascular surgery, far surpassing the current standard of care.

Med-tech powerhouse Johnson & Johnson made a bold bid to bolster its interventional cardiology holdings with the news on April 5 that it is acquiring Shockwave Medical Inc. for approximately $13.1 billion including cash acquired. The $335 per share cash price represents a more than 5% premium to Shockwave’s (Nasdaq: SWAV) April 4 closing price.

The Cari-Heart, a medical imaging technology which detects signs of inflammation around coronary arteries, can predict the risk of a cardiac event, independent from clinical risk scores and the interpretation of coronary computed tomography angiography (CCTA), according to data from a study presented at the recent American Heart Association Scientific Sessions.

Caristo Diagnostics Ltd. is deploying its medical imaging technology, Cari-Heart, at several NHS hospitals in a pilot project that will help identify patients at risk of heart attack years before it occurs. Cari-Heart detects signs of inflammation around coronary arteries. “No other company is doing this,” Frank Cheng, CEO of Caristo told BioWorld. “No one is using CT to quantify and visualize coronary inflammation” to predict the risk of a heart attack years in advance.

Shockwave Medical Inc. enrolled the first patient in its EMPOWER CAD study, the first prospective, all-female study of percutaneous coronary intervention (PCI). The study seeks to confirm the benefits of coronary intravascular lithotripsy (IVL) in female patients with calcified lesions. Women have historically been underrepresented in cardiovascular trials and have had less favorable outcomes in response to therapies.