Author: Ken Dropiewski

GE HealthCare Announces Agreement to Acquire IMACTIS to Strengthen Capabilities in Interventional Guidance

Acquisition expected to provide significant future expansion opportunity for the IMACTIS CT-Navigation system through GE HealthCare’s large installed base and global scale IMACTIS CT-Navigation enables intuitive pre-planning, continuous control, and navigation throughout a range of minimally invasive percutaneous procedures This acquisition is the latest example demonstrating that GE HealthCare is executing […]

BioSig Executes Agreement with Bellin Health for the Acquisition of its PURE EP™ Technology

Westport, CT, Jan. 10, 2023 (GLOBE NEWSWIRE) — Leading Midwest healthcare system reports significant cost savings and noise reduction following evaluation of the PURE EP™ System Medical center signs agreement to acquire the Company’s digital signal processing technology for arrhythmia care BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) an advanced […]

MedAlliance SELUTION SLR is the first DEB to receive coronary de novo IDE approval, its fourth FDA IDE DEB Approval

GENEVA, Jan. 10, 2023 /PRNewswire/ — SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, has received conditional FDA Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of coronary de novo lesions. This comes less than eight months after the company received its first IDE approval for SELUTION SLR in the treatment […]

Amarin Provides Preliminary Fourth Quarter and Full Year 2022 Revenue and Cash Position and Priorities for 2023

— Company Delivers Fourth Consecutive Quarter of U.S. Revenue Stabilization, Positive Fourth Quarter Cash Flow and Continued Progress on European Reimbursements — — Amarin to Present at 41st Annual J.P. Morgan Healthcare Conference on January 10, 2023 — DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 10, 2023 (GLOBE NEWSWIRE) — Amarin […]

Solid Biosciences Outlines Strategy for Leadership in Precision Genetic Medicines with Focus on Neuromuscular and Cardiac Diseases

– Investigational New Drug (IND) application for SGT-003, next-generation gene therapy for Duchenne muscular dystrophy utilizing novel capsid AAV-SLB101, expected in 2H-2023 – – Candidate selection and transition manufacturing process to transient transfection for AVB-202 for Friedrich’s Ataxia and AVB 401 in dilated cardiomyopathy continue – – Kevin Tan named Chief Financial Officer, experience […]

Prevencio Announces National Medicare Pricing for Company’s Three AI-Powered HART® Cardiac Blood Tests

Newly Assigned Rates Further Validate Commercial Value of the HART Tests KIRKLAND, Wash.–(BUSINESS WIRE)–Prevencio, Inc., The AI-Powered Cardiac Blood Test Company, today announced the Centers for Medicare & Medicaid Services (CMS) has set a National Medicare payment rate of $390.75 for each of the Company’s three lead proprietary HART® cardiac blood tests. […]

Rocket Pharmaceuticals Expands Cardiac Gene Therapy Portfolio with Addition of RP-A601 for PKP2-ACM and Announces Positive Updated Phase 1 Data for RP-A501 in Danon Disease

RP-A601 for Arrhythmogenic Cardiomyopathy due to PKP2 pathogenic variants (PKP2-ACM) represents meaningful commercial opportunity with estimated prevalence of 50,000 adults and children in the U.S. and EU; IND filing anticipated in Q2 2023 In support of Phase 2 pivotal study, latest positive Phase 1 data in Danon Disease recently shared […]

Valbiotis Announces Its Roadmap for 2023: a Pivotal Year in the Execution of Its Clinical, Industrial and Commercial Strategy

A decisive year in clinical terms with results expected in the first half of 2023 from the international Phase II/III REVERSE-IT study on TOTUM•63, a plant-based active substance that has already demonstrated metabolic benefits in prediabetic patients in a previous clinical study; Ramp-up of industrial and commercial operations with a […]

Quanterix Announces Appointment of Brian Blaser to Board of Directors

BILLERICA, Mass.–(BUSINESS WIRE)–Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, today announced that it has appointed Brian Blaser to its Board of Directors effective as of January 6, 2023. Mr. Blaser brings over 25 years of senior leadership experience in the in-vitro diagnostics industry, including 15 […]