The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device status to Empirical Spine Inc.'s LimiFlex Paraspinous Tension Band. Read More →
Sentien Biotechnologies, Inc., a clinical-stage biotechnology company developing novel approaches to cell therapy, today announced it has completed enrollment of the first cohort in its Phase 1/2 study of SBI-101 for the treatment of severe COVID-19. SBI-101, Sentien’s innovative cell-based therapy, is being evaluated in COVID-19 patients suffering from both acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI) requiring renal replacement therapy (RRT). Read More →
Augmedics, a pioneer in augmented reality surgical image guidance, announced today that it has raised $36 million in an over-subscribed Series C financing with an international syndicate of Israel-US investors. Read More →
PolyVascular Hires Will Clifton, MD, as COO to Manage Path to Human Trials in US; Ultimate Goal to Help 1 Million Pediatric Patients With Congenital Heart Disease Around the World With More Dependable and Affordable Solution. Read More →
South Korean medical AI company made its debut on KOSDAQ, a trading board of Korea Exchange, for an IPO of 37.8 billion won ($33.6 million) by issuing 1.8 million shares. Read More →
Another French company -- CorWave -- is developing a device for people with less severe heart failure. It helps pump blood from one of the heart's four chambers, rather than replacing the whole heart. Read More →
Lightpoint Medical, a medical device company developing miniaturized cancer detection tools for robot-assisted surgery, announced today that it has completed an $8 million financing round. Read More →
Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced the 100th global implant of the Cordella Pulmonary Artery Pressure Sensor (Cordella Sensor) by Cardiologist and top worldwide implanter Faisal Sharif, MD of Bon Secours Hospital and Director of Cardiovascular Research at NUIG, both in Galway, Ireland. Read More →
LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved its Clinical Trial Notification (CTN) for the Japanese cohort of the ongoing PROMISE II pivotal trial of the LimFlow Percutaneous Deep Vein Arterialization (pDVA) System. Read More →
In February 2020, SeaSpine announced that it had entered into a strategic alliance agreement to distribute 7D Surgical’s flagship navigational system founded on its machine-vision, image-guided surgery platform. Read More →
ExplORer Surgical, the only comprehensive intraoperative case support and workflow platform for surgical teams, is announcing enhanced efficiency and proficiency through its powerful data insight technology. Read More →
Vetex Medical Ltd. today announced positive one-year results from a European clinical study of patients with iliofemoral vein thrombus that demonstrated that the ReVene® Thrombectomy Catheter significantly improved their symptoms and quality of life, while reducing their leg swelling. Read More →
Bigfoot Biomedical, a company dedicated to better health outcomes for people with insulin-requiring diabetes, announced today that it has secured new financing of up to $57 million from Madryn Asset Management LP, an alternative asset management firm focused on investments in innovative health care companies. Read More →
Inflammatix, a pioneering molecular diagnostics company, announced today the closing of a $102 million Series D round of financing to support development and commercialization of its novel immune response diagnostics portfolio. Read More →
Remedee Labs is now scheduled to conduct a clinical trial, scheduled to begin in the second quarter of 2021, for a period of 12 months. This project is being carried out jointly with the CHU Grenoble Alpes, the Clinatec research center, the National Institute for Health and Medical Research (Inserm) and the company STMicroelectronics. Read More →
The United States Food and Drug Administration (FDA) has granted Promaxo, Inc. (Promaxo) a 510(k) clearance for its revolutionary office-based MRI system. The 510(k) clearance enables practices and hospitals to accurately and seamlessly guide prostate interventions under the Promaxo scanner. Read More →
Access Vascular, Inc., a company addressing the most common and costly venous access complications, today announced it has closed on a Series B round of financing. Read More →
The SCS-P (14P) is intended to treat patients suffering from PAD with heavily calcified above-the-knee (ATK) and below-the-knee (BTK) chronic total occlusions (CTO). Read More →
Vetex Medical Ltd. today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the ReVene® Thrombectomy Catheter. ReVene uses dual-action technology designed to de-clot peripheral vessels, such as in Deep Vein Thrombosis (DVT), through wall-to-wall contact in a single session without the use of thrombolytics. Read More →