Exact Imaging today said it received CE Mark approval for its Sterile Transperineal Needle Guide for use with its EV29L transducer. The Sterile Transperineal Needle Guide, when used with the ExactVu micro-ultrasound system, allows urologists to perform targeted prostate biopsies using the near-microscopic resolution of the micro-ultrasound. “In some markets, there is increasing movement toward […]
Exact Imaging
7 medtech stories we missed this week: May 11, 2018
From ReShape submitting an approval application to Health Canada to Conavi receiving FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. ReShape submits for Health Canada approval of ReShape balloon ReShape announced in a May 10 press release that it has submitted an application to the Medical Devices Bureau […]
Exact Imaging wins CE Mark for FusionVu micro-ultrasound/MRI fusion application
Micro-ultrasound developer Exact Imaging said today it won CE Mark approval in the European Union for its Fusion Vu application designed for micro-ultrasound/MRI fusion-based targeted prostate biopsies. The newly cleared application allows urologists to perform either cognitive fusion via Cognitivie Assist or micro-ultrasound/MR fusion on a high resolution platform, which the company said provides the “highest real-time […]
7 medtech stores we missed this week: March 10, 2017
The FDA and Health Canada cleared a couple medical devices while other companies touted their device studies. Here are 7 medtech stories we missed this week but were still worth mentioning. 1. FDA clears Medela’s neonatal enteral feeding device Medela has received 510(k) clearance from the FDA to market its ENFit Low Dose Tip eternal […]
Exact Imaging raises $16m in Series C to support ExactVu micro-ultrasound
Micro-ultrasound developer Exact Imaging said today it raised $16.3 million (CDN $21.5 million) in a Series C funding round, with funds slated to support the commercialization of its ExactVu micro-ultrasound system. The round, which closed late last year, was led by Lumira Capital and Vesalius Biocapital and joined by newly invested PMV and previously invested iGan […]
BioSciKin puts $2m into Exact Imaging
Micro-ultrasound developer Exact Imaging said today that Chinese bio-tech company BioSciKin is investing $2.2 million (CDN $3 million) as a syndicate partner in Exact Imaging’s $15.8 million (CDN $20.7 million) round of fundraising to support its ExactVu tech designed for prostate cancer imaging.. The announcement was made during the Commercial Signing Ceremony as part of […]