Sava Technologies Ltd. reported positive clinical data showing that its multi-molecule biosensor technology can reliably monitor glucose levels beneath the skin in real time.
Investors poured a further $13 million into Vicentra BV for Kaleido, its insulin patch pump system, taking the total raised in the company’s series D financing round to $98 million. The funds come amid significant changes across diabetes technology, particularly the acceleration of patch pumps. Kaleido is one of the smallest, lightest, and most precise insulin patch pumps available.
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.