BEDFORD, Mass.–(BUSINESS WIRE)–SpectraWAVE, Inc., a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for product enhancements to the HyperVue™ Imaging System. The intravascular imaging system combines next-generation DeepOCT™ images and near […]
Other News
Elutia Announces Private Placement for Proceeds Up to $26 Million
SILVER SPRING, Md., Sept. 19, 2023 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia”), a company pioneering drug-eluting biomatrix products, today announced that it has entered into a securities purchase agreement for a private placement (PIPE) financing that is expected to result in initial gross proceeds to the Company of […]
Impulse Dynamics Announces Leadership Changes
MARLTON, N.J., Sept. 19, 2023 (GLOBE NEWSWIRE) — Impulse Dynamics plc, a global medical device company dedicated to improving the lives of people with heart failure, announced new leadership appointments, including Jason Spees to Chief Executive Officer, Shlomi Nachman to Chairman of the Board, and John Liddicoat, M.D., as a […]
Orchestra BioMed Granted FDA Approval of IDE to Initiate BACKBEAT Pivotal Study of BackBeat CNT™ for the Treatment of Hypertension in Pacemaker Patients
NEW HOPE, Pa., Sept. 19, 2023 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the U.S. Food and Drug Administration (“FDA”) granted approval of an investigational device exemption (“IDE”) to […]
HOPPR appoints world-renowned radiologist and AI pioneer, Dr. Khan M. Siddiqui, as CEO
CHICAGO, Sept. 19, 2023 /PRNewswire/ — In a groundbreaking move, HOPPR, an AI company that is changing medical imaging forever by enabling a GPT-4-like interaction with medical imaging studies, is proud to announce the appointment of Dr. Khan Siddiqui as its Chief Executive Officer. The original pioneer of radiology informatics, a world […]
Adagio Medical Announces Initiation and First Procedure in FULCRUM-VT Trial, Starting The Process For Bringing Ultra-Low Temperature Cryoablation for Ventricular Arrhythmias to US Market
LAGUNA HILLS, Calif., Sept. 14, 2023 /PRNewswire/ — Adagio Medical, Inc., a leading innovator in catheter ablation technologies for atrial fibrillation (AF) and ventricular tachycardia (VT), announced the first ultra-low temperature cryoablation (ULTC) procedure performed using the Adagio vCLAS™ catheter system in the United States as part of the FULCRUM-VT (Feasibility of Ultra-Low Temperature Cryoablation for Recurring Monomorphic Ventricular Tachycardia) clinical trial, NCT # […]
Saranas Successfully Completes Enrollment of Clinical Trial Assessing the Utility of Early Bleed Detection in Patients Undergoing Mechanical Circulatory Support
HOUSTON–(BUSINESS WIRE)–Saranas, Inc. announced today that it has completed enrollment in SAFE-MCS, a multi-center, single arm, open-label clinical trial evaluating the safety of complex high-risk percutaneous coronary intervention (PCI) using mechanical circulatory support (MCS) and surveillance with the Early Bird® Bleed Monitoring System. The Early Bird Bleed Monitoring System is the […]
Route 92 Medical Announces Appointment of Jonathan Kennedy as Chief Financial Officer
SAN MATEO, Calif., Sept. 18, 2023 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the appointment of Jonathan Kennedy to the role of Chief Financial Officer. In this role, Jonathan will be responsible for […]
Verve Expands Leadership Team with Appointment of Frederick T. Fiedorek, M.D., as Chief Medical Officer
BOSTON, Sept. 18, 2023 (GLOBE NEWSWIRE) — Verve Therapeutics, a clinical-stage biotechnology company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today announced the appointment of Frederick “Fred” T. Fiedorek, M.D., as chief medical officer (CMO). Andrew Bellinger, M.D., Ph.D., the current chief scientific […]
CereVasc Receives FDA IDE Approval to Expand its Clinical Study of Patients with Normal Pressure Hydrocephalus Utilizing the Generation 2 eShunt® System
BOSTON, Sept. 18, 2023 /PRNewswire/ — CereVasc, Inc., a clinical-stage, medical device company developing novel treatments for neurological diseases, announced that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) supplement to permit the expansion of the study of the eShunt System in patients with Normal Pressure […]



