Companies that develop software that functions as a medical device should be aware that the Food and Drug Administration (FDA) has issued draft guidance that, once finalized, will classify the endless variety of Software as a Medical Device (SaMD), and impose risk-based criteria for evaluating the safety and effectiveness of such software. The draft guidance, titled Software as a Medical Device (SaMD): Clinical Evaluation,” is an attempt to determine what type of clinical evaluation is appropriate for SaMD that...

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In the business world, unfortunately, the rearview mirror is always clearer than the windshield.”– Warren Buffett, Chairman and CEO, Berkshire Hathaway Inc. “Trying to predict the future is like trying to drive down a country road at night with no lights while looking out the back window.” – Peter Drucker, management consultant, educator, and author As we examine the current state of the mergers and acquisitions (M&A) market, I find myself reflecting upon two favorite quotes, which remind us that historical...

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Next week, Americans will head to the polls to elect their 45th President. Across the nation, voters will also fill 469 congressional seats, including 435 in the House and 34 in the Senate. While these federal races tend to occupy much of the coverage and discussion as November 8 approaches, issues closer to home should not be overlooked. Voters in 12 states will select governors, and many ballots will feature proposed constitutional amendments or local initiatives. As the saying goes,...

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NEW YORK, NY, USA -  World Trade Centers Association, Inc. (WTCA) has named Alexander Brown (Alex) as its new Director of Communications and Member Relations. With more than 15 years of experience positioning brands, organizations and thought leaders, Brown is charged with spearheading organizational strategy in both of these two important areas.   WTCA’s CEO, Scott Ferguson, said, “We are delighted to bring Alex on as our new Director to help us tell our global story, which in turn supports our...

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NEW YORK, NY, USA - The 2016 Member Seminar, held October 16-18 in New York City, drew 116 participants, of which 97 were WTC delegates representing 67 World Trade Centers. This year’s Member Seminar was focused on engaging and activating our Members, new and old, with the focus of strengthening our network through knowledge and education, and most importantly, through networking. WELCOME COCKTAILS The Seminar began with the Welcome Cocktails, where Members had the opportunity to reconnect with their peers over light...

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AlixPartners announces new ownership structure to support long-term growth CDPQ, PSP Investments, Investcorp and Jay Alix to acquire ownership stakes from CVC Capital Partners AlixPartners employees will continue to have a significant ownership stake New York – 7 November, 2016 – AlixPartners, the global advisory firm, today announced a group led by the firm’s founder, Jay Alix, and three leading global investors, has agreed to acquire ownership stakes in the business from CVC Capital Partners (“CVC”). The transaction values AlixPartners...

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DKMS Global Ambassador & Co-Founder, Katharina Harf and longtime supporter Charlotte Santo Domingo co-hosted DKMS’ highly anticipated Halloween benefit, The Blood Ball, last night at Diamond Horseshoe in Times Square. Amidst the 500 guests enjoying the party, Event Chair Santo Domingo expressed how much their support makes a difference. “By being here tonight, we are joining the fight to delete blood cancer once and for all. DKMS has made incredible strides over the years, registering nearly 7 million donors worldwide! But...

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On October 27, 2016, the New York City Council approved a bill that would establish protections for freelance workers.  It is expected that Mayor Bill de Blasio will sign the bill into law in the near future. The bill, entitled “Establishing Protections For Freelance Workers,” defines a freelance worker as a single person, or an entity composed of no more than one person (whether incorporated or using a trade name), that is retained as an independent contractor to perform services...

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Last week, the EU Commission proposed to extend the scope of the EU hybrid mismatch rules by way of an amendment to the EU Anti Tax Avoidance Directive (the "ATAD"; see our Tax Alert of 23 June 2016 for further background. Under the proposed amendments to the EU hybrid mismatch rules, in contrast to the current scope, they will also apply to hybrid mismatches with third countries. Furthermore, the rules will apply to inter alia permanent establishment mismatches, dual resident mismatches...

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October 28, 2016 – New York – More than any other country, American consumers make purchases that cater to risk-taking, adventure and personal values, according to global research by HSBC. This structural shift among US consumers’ purchasing habits is prompting companies to re-think existing marketing and business strategies. According to the HSBC Future of Consumer Demand report, changing demographics and consumer behavior will present new opportunities for savvy American companies in the coming decades whilst posing threats to traditional business...

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