Innoblative’s SIRA™ RFA Electrosurgical Device Receives FDA Clearance
CHICAGO, April 9, 2019 /PRNewswire/ — Innoblative Designs, Inc. (Innoblative), a private medical device company committed to developing next generation, advanced-energy surgical solutions, announced it received U.S. Food and Drug Administration (FDA) clearance for its SIRA™ RFA Electrosurgical Device, a novel radiofrequency ablation (RFA) applicator... Read More →
SafeHeal obtains CE-mark for Colovac, its novel endoluminal bypass sheath
Paris, France, April 3, 2019 – SafeHeal, a leading innovator in the field of digestive surgery, announces today that its unique Colovac bypass sheath has received the CE-mark. Colovac is a unique endoluminal bypass sheath placed in the colon following colorectal resection.... Read More →
UK patient first to be treated with clot-removing device
A UK patient has become the first in the world to be treated using a new clot-removing device. Jackie Field, from Eltham in south-east London, was diagnosed with deep vein thrombosis and underwent the procedure at St Thomas’ Hospital in... Read More →
Prospective Pilot Shows AI to Have Higher Accuracy in Detecting Cervical Cancer Than Lab Tests
MobileODT’s CDS Algorithm Shows Impressive Results in First Real-Time Application of AVE for Cervical Cancer Screening The first prospective pilot into artificial intelligence for point-of-care visual cervical cancer detection found it to be more effective than current laboratory-based methods. Automated visual... Read More →
FDA clears Spry Health’s remote monitoring wearable for COPD patients
Built for patients with COPD and other chronic conditions, the Loop System continuously collects and analyzes health data to warn providers of potential deterioration. The company says it has already inked a deal with a major health system. The Loop... Read More →
Irish medical devices company CroíValve raises 3.2 Million
Early-stage medical devices company CroíValve has raised €3.2 million oversubscribed seed financing round. The company, which has developed a minimally invasive device to treat defective heart valves, is a spin-out from Trinity’s Centre for Bioengineering. Its device is a safe... Read More →
Vision and passion drive successful entrepreneurs
Successful entrepreneurs have vision. They are driven by passion and possibilities. It is a privilege to watch them in action. A case in point is Dr. Ryan Dennis, CEO of Linear Health Sciences, a medical device company whose safety valve... Read More →
Abreos Biosciences Announces Research Collaboration with FDA-CDER
SAN DIEGO (PRWEB) MARCH 26, 2019 Abreos Biosciences, a San Diego-based biotech company and leader in precision dosing of biological therapeutics, is pleased to announce a research collaboration with the FDA’s Center for Drug Evaluation and Research (CDER) to develop several... Read More →
Genetesis CardioFlux™ platform receives FDA 510(k) clearance
(Mason, OH March 22, 2019 8 am) Genetesis, a medical technology company focused on using biomagnetic imaging to enable rapid, noninvasive and accurate chest pain triage, has received FDA 510(k) clearance for its cardiac imaging platform. The platform pairs the... Read More →
Vixiar Medical Nabs $1.5M to Expand Hand-Held Devices for Cardiac Monitoring
Vixiar Medical, Inc., a Baltimore, Maryland-based company dedicated to the development of non-invasive devices and systems for monitoring cardiopulmonary diseases has raised $1.5 million from new and existing investors. New investors joining in this round included Emerald Development Managers, MMG Opportunities and several... Read More →