FDA Awards Genetesis Breakthrough Device Designation for CardioFlux® Imaging Technology
CardioFlux®, the most advanced commercially available magnetocardiograph (MCG), leverages highly sensitive room temperature magnetometers to deliver noninvasive measurement of the heart’s naturally-generated magnetic fields. Read More →
Osteoporosis Prevention Product Wins FDA Breakthrough Device Designation (featuring Bone Health Technologies)
Bone Health Technologies, creator of the OsteoBoost Vibration Belt that promises to reduce the risk of osteoporosis, has been granted “Breakthrough Device” designation by the US Food & Drug Administration. The FDA awards Breakthrough Device designation to products “that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.” Read More →
Avelas Receives FDA Breakthrough Therapy Designation for Pegloprastide (AVB-620) for Use During Breast Cancer Surgery
Avelas Biosciences, Inc., pioneering the field of intraoperative fluorescent cancer imaging, today announced that the company has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for pegloprastide (AVB-620) for the intraoperative detection and visualization of positive margins during breast cancer surgery. Read More →
U.K. Invests $330M to Lead the World In Healthcare AI (featuring Kheiron Medical Technologies)
This first tranche of investment boasts companies at a range of stages, from minimum viable products to established companies ready to scale. Read More →
Smart Stethoscope Helps Monitor and Diagnose Respiratory Conditions: Interview with Helena Binetskaya, CEO of Healthy Networks
LungPass, an AI-powered Bluetooth stethoscope has been developed by Healthy Networks, a company based in Talinn, Estonia. The device can analyze sounds from the lungs and help to diagnose or monitor a variety of respiratory conditions, with an initial focus on pneumonia and COPD. Read More →
Day Zero Diagnostics Wins $300K NIH Grant to Refine HAI Outbreak Analysis Service
Infectious disease startup Day Zero Diagnostics last week received a $300,000 grant from the National Institutes of Health to further develop its nanopore sequencing-based technology for the analysis of healthcare-associated infection (HAI) outbreaks. Read More →
Conversations with Medtech Pioneers: MedTech Innovator’s 2020 Grand Prize Winner, Rhaeos
At Advamed’s Medtech Conference, the top 5 finalists pitched with the Grand Prize awarded to Rhaeos CEO, Anna Lisa Somera. Rhaeos has a novel wireless, wearable sensor for the monitoring of shunts in patients with Hydrocephalus. Read More →
Safety and Efficacy of Intermittent Colonic Exoperistalsis Device to Treat Chronic Constipation: A Prospective Multicentric Clinical Trial, featuring MOWOOT
MOWOOT automatically provides intermittent colonic exo-peristalsis (ICE) treatment like that in manual massage. Read More →
This Startup Is Changing Cancer Detection Around the World (featuring X-ZELL)
X-ZELL is developing an accurate, affordable, and globally scalable early cancer detection from 10mL blood samples, which is unprecedented. Read More →
Vectorious’ In-Heart Microcomputer Wins FDA Breakthrough Nod
The V-LAP system is the first digital, wireless, battery-free device that can communicate from deep within the body using high-resolution waveform morphology, according to the Tel Aviv-based startup. Read More →