MedAware Systems Launches AI Post Market Surveillance for Neuromodulation Devices
MedAware Systems’ Science of Health Informatics (SOHInfo) announces the launch of its comprehensive AI-powered surveillance service for Spinal Cord and Peripheral Nerve stimulation devices from all major manufacturers. Read More →
HydroMID Midline Catheter from Access Vascular Receives FDA Clearance
Access Vascular, Inc. today announced FDA clearance of its HydroMID™ midline catheter. HydroMID, which is made of Access Vascular’s proprietary biomaterial that has been shown to reduce thrombus accumulation by up to 97 percent when compared to standard polyurethane catheters,1 is the second device in its planned portfolio to obtain clearance. Read More →
Fibralign Announces Start of European Lymphedema Prevention Clinical Study
Fibralign Corp., a Stanford spin-out and developer of therapeutic biomedical devices, today announced enrollment of the first patient in a multi-site, randomized clinical trial in Europe evaluating its BioBridge® Collagen Matrix as a novel preventative treatment for secondary lymphedema. Read More →
Puzzle Medical Devices Inc. Receives U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for Its Revolutionary Minimally Invasive Transcatheter Heart Pump
Puzzle Medical Devices Inc., (www.puzzlemed.com) announced today that the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for its revolutionary transcatheter pump to address heart failure. Read More →
Flow expands portfolio of brain stimulation technologies with Halo acquisition
Swedish firm Flow Neuroscience has added to its portfolio of brain stimulation technologies for improving mental wellbeing by acquiring US start-up Halo Neuroscience. Read More →
Interventional Robotics Startup Moray Medical Secures $3.3 Million Seed Financing Led by 415 CAPITAL
Moray Medical announced today that it has raised $3.3 million in seed funding led by 415 CAPITAL, which invested alongside a number of prominent medtech entrepreneurs. Read More →
PEDRA™ Technology Receives FDA Breakthrough Device Designation for its PEDRA™ Xauron™ Real-Time Tissue Perfusion System
PEDRA™ Technology, a privately-held company, announced today that the U.S Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for the periprocedural use of its PEDRA™ Xauron™ Perfusion System in the treatment of critical limb threatening ischemia (CLTI). Read More →
Alleviant Medical Receives Breakthrough Device Designation From FDA for Transcatheter Technology
The technology offers a no-implant interatrial shunt therapy for patients suffering from heart failure with preserved (HFpEF) and mid-range ejection fraction (HFmrEF) who remain symptomatic despite optimal guideline directed medical therapy. Read More →
Israeli AI FemTech solution secures prestigious US cancer grant of $2.3M to advance women’s health (featuring MobileODT)
MobileODT, an Israeli FemTech startup focusing on AI-powered cervical screening, has caught the eye of the US National Cancer Institute (NCI), with the NCI awarding Mobile ODT with a $2.3 million grant. The Small Business Innovation Research Authority grant is given by the NCI to companies that are technologically and clinically reducing the suffering from cancer. Read More →
Harvard spin-off CELLVIE closes $5M seed round in pursuit of a new treatment modality: therapeutic mitochondria transfer
cellvie Inc., the leader in Therapeutic Mitochondria Transfer (TMT) and a Harvard University spin-off, closes a $5M round to advance its product pipeline, including a first application in rejuvenation. Read More →