Yearly Archives: 2021

Enspectra Health Receives $4.0 Million NIH Grant to Advance a New Field of Virtual Biopsies

Enspectra Health received a Phase IIB award of $4.0 million under the National Institutes of Health'sĀ Small Business Innovation Research ProgramĀ for the continued development of its novel imaging technology to aid in the evaluation of nonmelanoma skin cancers.

Varian Receives FDA “Breakthrough Device Designation” for its Cardiac Radioablation System

Varian, a Siemens Healthineers company, announced today that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation for its cardiac radioablation (CRA) system, currently in development as a noninvasive therapy for select patients with refractory ventricular tachycardia.

Visionairy Health Secures CE Marking for its AI-Based X-Ray Triage Tool

Today they announced they obtained CE Marking for X1, its artificial intelligence (AI) based chest x-ray triage and prioritization product.

FAST BioMedical Successfully Completes Open-Label Proof-of-Concept Study for Measuring Interstitial Volume

Conducted at the Richard L. Roudebush VA Medical Center in Indianapolis, the study evaluated the safety, tolerability and performance of the FAST Technology in chronic dialysis patients with extremely reduced or no kidney function.

Medtronic Secures Two CE Mark Approvals for Guardian 4 Sensor & for InPen MDI Smart Insulin Pen

In the United States, Guardian 4 sensor and the MiniMed 780G system are investigational use only and not approved for sale.