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Latest From Avinger, Inc.
Global Device Approvals, Weekly Snapshot: HeartMate 3 Reaches New Destination
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Among the additions, Abbott's HeartMate 3 left ventricular assist device gained "destination therapy" approval from US FDA, meaning its now vetted for use in patients who are not eligible for a heart transplant.
Clinical Trials Sought For Atherectomy Device 510(k)s In FDA Guidance
New US FDA draft guidance on 510(k)s for peripheral vascular atherectomy devices asks sponsors to submit clinical trial data due to lack of a good animal model.
Avinger Invests In Trials Of Lumivascular Peripheral Atherectomy Device As Company Restructures
US FDA-approval for an in-stent restenosis trial of Avinger's Pantheris atherectomy system comes on the heels of positive results from the VISION trial of the Pantheris in patients with peripheral arterial disease of the lower extremities. Meanwhile, the company is restructuring to cut its expenses by half as its stock has been stuck below a dollar a share since April.
Deals Shaping the Medical Industry, September 2016
Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, the Dealmaking column is a survey of recent health care transactions listed by relevant industry segment – In Vitro Diagnostics, Medical Devices, and Pharmaceuticals – and then categorized by type – Acquisition, Alliance, or Financing. This month’s column covers deals announced in August 2016.
- Diagnostic Imaging Equipment & Supplies
- Implantable Devices
Surgical Equipment & Devices
- Minimally or Less Invasive
Diagnostic Imaging Equipment & Supplies
- Digital Imaging
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