CE mark approval—Moderato implantable pulse generator system (Orchestra BioMed)
Orchestra BioMed has received CE mark approval for its Moderato implantable pulse generator system that is designed to deliver BackBeat Cardiac Neuromodulation Therapy for the treatment of hypertension while also providing standard pacemaker functions. Additionally, the Cardiovascular Research Foundation (CRF) has selected the MODERATO II clinical study, which evaluated BackBeat CNT, to be presented during a late-breaking science session at the 2019 Transcatheter Cardiovascular Therapeutics (TCT) meeting (25–29 September, San Francisco, USA).

FDA approval (510(k) clearance)—CAM 14-day (Bardy Diagnostics)
Bardy Diagnostics has received 510(k) clearance from the FDA for a 14-day version of the Carnation Ambulatory Monitor (CAM), which a press release says is market’s only P-wave centric ambulatory cardiac patch monitor and arrhythmia detection device. Developed to provide clinicians greater flexibility in cardiac monitoring over a longer period, the CAM patch will now be offered in a 14-day extended wear version that use the same P-wave focused technology that powers the existing two-day and seven-day CAM product lines

FDA Breakthrough Device Designation (Shockwave Medical)
Shockwave Medical has received Breakthrough Device Designation from FDA for its Shockwave intravascular lithotripsy (IVL) system with the Shockwave C2 coronary IVL catheter, which is currently the subject of an Investigational Device Exemption (IDE) study called DISRUPT CAD III. A press release reports that the Shockwave C2 IVL catheter is a proprietary tool designed to fracture problematic calcium using sonic pressure waves to facilitate stent delivery, deployment and optimal expansion, thereby improving blood flow to the heart muscle.