Gottlieb’s Departure Should Not Siderail Reforms to 510(k) Pathway

The unexpected resignation of Dr. Scott Gottlieb from the Food and Drug Administration last week gave the life sciences industry pause. Gottlieb has been an agile leader, who proved himself to be ready and willing to help the agency evolve as the health care sector becomes more technology-centric. It is reported that he issues more than 200 guidances a year, many aimed at easing the way for new technologies including digital therapeutics, gene therapies and wearable medical devices. His two-year … Continued

Steady as She Goes: Medtech Venture Investment Q3 2018

Venture investment in the medical device sector has held remarkably steady over the course of 2018 according to the PwC/CB Insights Healthcare MoneyTree report. According to the report, medical device companies took in $750 million in venture investment in Q3, 2018, nearly the same amount as in Q1 and Q2 ($772 million and $780 respectively). That is consistent with investment in the sector in 2017 which averaged $771 million a quarter. However, investment in the sector was bumpier in 2017, ranging from a … Continued

United States Issues Patent Number 10,000,000

This week the United States Patent and Trademark Office (USPTO) issued U.S. patent number 10 million. More than just a number, patent 10 million celebrates the rich history and strength of the American intellectual property system dating back to the first U.S. patent, signed 228 years ago by George Washington on July 31, 1790, and issued to Samuel Hopkins for a process of making potash, an ingredient used in fertilizer. “Innovation has been the lifeblood of this country since its … Continued

EPO Revokes the Broad Institute’s CRISPR Patent

The European Patent Office (EPO) has revoked a foundational CRISPR-Cas9 patent granted in Europe to the Broad Institute of Cambridge Massachusetts. The patent at issue was filed in December 2013, but cites U.S. patent applications dating back to December 2012 in order to show its claims predate a patent filing by the University of California, Berkeley. The EPO’s decision was based on the fact that Broad’s 2012 and 2013 U.S. patent filings include Luciano Marraffini of Rockefeller University as an … Continued

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