BGN Technologies, the technology transfer company of Ben-Gurion University (BGU), introduced a novel method for producing radioisotopes for nuclear medicine and medical imaging technologies such as computed tomography (CT) scan and positron emission tomography-computed tomography (PET-CT).

Orchestra BioMed Inc. announced the presentation of two-year clinical data from the European Moderato I study of BackBeat Cardiac Neuromodulation Therapy (“BackBeat CNT”) for hypertension at the EuroPCR Conference, May 21-24 in Paris, France. Prof. Petr Neužil, M.D., Ph.D., CSc., FESC, head of the department of cardiology of Na Homolce Hospital in Prague, Czech Republic, presented data which showed a strong safety profile of BackBeat CNT and its ability to immediately, substantially and chronically lower blood pressure in patients with persistent hypertension (office BP > 150 mmHg) despite two or more anti-hypertensive medications and an indication for a pacemaker.

Terumo Medical Corp. is recalling the SoloPath Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System due to a potential for the tip to dislodge from the outer rim of the sheath. This may result in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.

Amarin Corp. plc announced that its supplemental new drug application (sNDA) for Vascepa (icosapent ethyl) capsules has been accepted for filing and granted Priority Review designation by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this sNDA is Sept. 28, 2019. Because of the Priority Review designation, the timing of this PDUFA date is four months earlier than the anticipated standard ten-month review for applications.