From Zetta getting FDA clearance to Prescient Medical receiving CE Mark approval, here are five medtech stories we missed this week but thought were still worth mentioning. 1. Zetta wins FDA clearance for Zoom MRI software Zetta announced in a June 25 press release that its MRI software has received FDA 510(k) clearance. The software, known […]
Medtronic (NYSE:MDT) won 510(k) clearance from the FDA for the Aquamantys surgical sealer it acquired when it paid $480 million for Salient Surgical Technologies last year.
AtriCure (NSDQ:ATRC) shares got a modest bump today after revealing pre-market approval from the FDA for its Synergy radiofrequency ablation system for atrial fibrillation.
ATRC shares were up 2.1% to $10.86 as of about 1 p.m. today.
MIM Software Inc.’s diagnostic medical imaging app for the Apple Inc. (NSDQ:AAPL) iOS platform is now available for download.
The Food & Drug Administration-cleared diagnostic is the first-ever mobile radiology app to receive the agency’s seal of approval.
It took nearly three years and three 510(k) applications, but MIM Software finally won Food & Drug Administration clearance for its Mobile MIM app, the first-ever mobile radiology app to receive the agency’s seal of approval.
The process was so fraught with confusion and miscommunication — or worse, no communication — that MIM CTO Mark Cain likened the experience to falling into a "black hole."