Repro Med Systems, Inc. dba KORU Medical Systems, a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and easy-to-use specialty infusion solutions that improve quality of life for patients, today announced 510k clearance for use of the KORU Medical FreedomEdge® infusion system to deliver pegcetacoplan 20 mL solution, branded as EMPAVELI® or Aspaveli® and commercialized by Apellis in the United States and by Sobi outsi

VideaHealth, a dental AI pioneer, today announced the U.S. Food and Drug Administration (FDA) has issued 510(k) clearance for Videa Caries Assist, an AI-powered dental caries (cavity) detection algorithm. VideaHealth surpassed the FDA’s exacting efficacy requirements by significantly aiding the analysis of radiographs instantly from the dentist’s chair. In the FDA trial, the number of missed caries was 43% lower for dentists using Videa’s AI. Notably, the dentists

Acclaro Corporation, (formerly FA International LP, Boston, Mass.), breaks new ground in medical devices for aesthetics with their revolutionary UltraClear™ system. This disruptive technology features a no downtime, painless treatment to address a full spectrum of skin conditions including pigmentation, enlarged pores, fine lines, wrinkles, scars and acne scars, age spots, sun damage, textural irregularities and general complexion issues. It is safe for all skin types, including darker

AmerisourceBergen (AB), a global healthcare company, today announces a program designed to help hospitals and health systems launch or optimize home infusion service lines. As site-of-care strategies grow in importance, health systems with strong outpatient infusion center performance are increasingly leveraging home infusion to prevent potential care gaps, particularly as therapeutic advancements continue to broaden the range of treatments available for the home. Each phase of AB’s sol

Hackensack University Medical Center launched an innovative surveillance program that screens individuals who are at high-risk for developing pancreatic cancer. The IMMray® PanCan-d Test is the first blood test on the market dedicated to the early detection of familial or hereditary pancreatic ductal adenocarcinoma (PDAC). Patients who are eligible will receive both an imaging test and a novel biomarker test that measures the immune system's response to pancreatic

Boston Imaging, the United States headquarters of Samsung digital radiography and ultrasound systems, introduces the GM85 Fit, a new configuration of the premium AccE GM85; a digital radiography device featuring a user-centric design that aids in efficient and effective patient care. The GM85 Fit recently received 510(k) clearance from the U.S. Food and Drug Administration for commercial use in the USA. “We are pleased to launch the GM85 Fit. It’s designed with the user

TAG – The Aspen Group, a nationwide leader in consumer health care, and ACE Surgical Supply, a leading global provider of bone regenerative products, today announced a multi-year strategic partnership for bone grafting solutions. TAG's brands include Aspen Dental, a network of nearly 1,000 doctor-owned dental offices across 45 states, and ClearChoice Dental Implant Centers, a leader in fixed full arch dental restorations for patients with missing or failing dentition with

Debiotech, a leading Swiss innovation company in the field of medical devices, announced today that the Versi™PD Cycler System, developed in close collaboration with its licensee Fresenius Medical Care, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This home peritoneal dialysis device is the smallest, lightest, and quietest cycler in the United States today. "This is a significant milestone in kidney replacement therapy that is being achi

Franklin Mountain Medical announced today that the company has received FDA clearance of its patented UltraNav Transseptal Catheter System for controlled access and delivery of cardiovascular catheters and guidewires to the heart chambers via transseptal puncture. The success of transseptal procedures depends on the clinician’s ability to adequately visualize the heart’s internal anatomy and catheters/needles being utilized. This visualization allows for precise puncture

BD (Becton, Dickinson and Company), a leading global medical technology company, today announced the launch of a new family of reagents that enables researchers to gain improved data resolution and greater insights from samples compared to traditional fluorochromes, made possible by their innovative development using novel dye technology and artificial intelligence (AI) guidance. The launch of BD Horizon RealYellow™ 586 Reagents marks the first fluorochrome in a series from th