Management is beaming with delight at Heartbeam Inc. as the company's appeal strategy paid off with U.S. FDA clearance for its synthetic 12-lead electrocardiogram software for the assessment of arrhythmias. In November, the Santa Clara, Calif.-based company received a Not Substantially Equivalent determination from the agency on its 510(k) application, which could have substantially delayed commercialization. Following a plan disclosed Nov. 28, the company resolved the agency's issues through an appeal process and active engagement and obtained clearance much more quickly than expected.

Teleflex Inc. reported plans to sell its Acute Care, Interventional Urology and OEM businesses to two buyers for $2.03 billion. Intersurgical Ltd. will acquire the Acute Care and Interventional Urology units for $530 million. Additionally, private equity firms Montagu and Kohlberg are buying its OEM contract manufacturing business for $1.5 billion.

Levron Medical Ltd. recently exited stealth mode to advance its cardio-respiratory physiology assist technology, designed to treat heart failure by synchronizing the heart and lungs. The approach harnesses the natural ‘respiratory pump’ to assist cardiac function and create what the company claims to be a new category of heart failure treatment.