US Approvals Analysis: 510(k) Clearances Spiked In May
Executive Summary
In May, US FDA achieved its highest monthly total of 510(k)s clearances in more than two years. Here's a snapshot of the agency's approval and clearance activity last month from Medtech Insight's Approvals Tracker.
You may also be interested in...
Earnings Winners & Losers: Medtech 'Pure-Plays' BSX, ISRG, BDX, VAR, RMD
The third of three Winners and Losers features covering the companies that announced sales and earnings results in late July and early August looks at major companies that only market medical devices aside from the orthopedics device makers that were covered in an earlier Winners and Losers feature.
US FDA Continues Shift From Companion To Complementary PD-L1 Diagnostics With AstraZeneca Imfinzi Approval
AstraZeneca's Imfinzi (durvalumab) is the third PD-1/L1 inhibitor approved for second-line bladder cancer with labeling that describes better response rates in patients with higher PD-L1 expression, but without a requirement for diagnostic testing.
US Approvals Analysis: 2016 Another Record Year For FDA Novel Device Approvals
The agency approved a total of 91 original PMAs, panel-track PMA supplements and de novo classifications in 2016, outpacing last year's record for approvals of novel devices or indications, according to Medtech Insight's Approvals Tracker. Medtronic topped both the novel device approvals and 510(k) clearance lists for the year. Roche, Abbott, Siemens and GE also showed strong approval and clearance counts.