Abbott has received an expanded FDA indication approval for its CardioMEMs HF System, making the solution available for patients in earlier stages (NYHA stage II) of heart failure (HF).
An estimated 1.2 million additional patients are now candidates for the company's small CardioMEMs HF monitor.
The study used non-contrast CT and CT perfusion imaging to analyze agreement between an automated reader and human radiologists with differing experience levels.
The FDA has cleared Medtronic's Freezor and Freezor Xtra cardiac cryoablation catheters for the treatment of pediatric atrioventricular nodal reentrant tachycardia (AVNRT).
The two single-use devices are now approved for the treatment of pediatric AVNRT.
The LDL-lowering medication inclisiran (Leqvio) was recently cleared by the FDA. It used only two doses per year. It was included it the Cleveland Clinic annual list of the top 10 medical innovations expected to make a big impact on patient care in 2022.
The FDA has already approved one of the medications, with a decision on another expected by the end of April.
Researchers examined data on more than 3,400 BP devices used all over the world. A significant majority of them were never clinically validated for accuracy.
The deal, first announced in October 2021, expands Boston Scientific’s structural heart disease and electrophysiology portfolios by a significant margin.
