Global Device Approvals, Weekly Snapshot: July 2-8, 2018
A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.
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FDA issued a final order on Jan. 28 requiring manufacturers of automated external defibrillators to submit premarket approval applications to market their products. This will immediately apply to new AEDs, but manufacturers of devices already on the market have 18 months to submit PMAs for those devices as long as they notify the agency by April 29.
The company will invest $62.5m for a new manufacturing and supply chain facility in Johns Creek, GA – about 30 miles northeast of Atlanta in Fulton County, according to Georgia Governor Brian Kemp.
The company announced the US launch of the AcQCross Qx transseptal dilator/needle. It is specifically designed to help deploy Boston Scientific’s Watchman left-atrial appendage closure device, but it is part of the left-heart access device portfolio that Acutus recently sold to Medtronic.