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2  3  4  Other modeling considerations will be provided on the webcast. WEBCAST INFORMATION: Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investors section of the company's website at events-and-presentations.  ABOUT JOHNSON & JOHNSON: At Johnson & Johnson, we believe good heal...

To embed, copy and paste the code into your website or blog: MDR”), which will govern medical devices software (“ MDSW”) in the EU, we turn to the transition periods certain MDSW can benefit from before being required to fully comply with the MDR. Transitional periods are provided in Article 120 MDR. In part due to the COVID-19 pandemic, the original text of Article 120 MDR has been corrected by two corrigenda (I, II) and another Regulation to avoid additional burdens to stakeholders and impasses in the supply of medical devices. The changes introduced by these amendments are twofold: O...

To embed, copy and paste the code into your website or blog: On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on regulatory and legal considerations for software as a medical device (SaMD) in both the United States and Europe and specific use cases for digital therapeutics and other digital health products. Speakers included Morrison & Foerster partners Bethany Hills and Wolfgang Schönig as well as special guest Corey McCann, president and CEO of Pear Therapeutics, in a fireside chat at...

In emerging as well as mature markets, we have seen the rise of smaller, more agile partners specializing on a specific sector or market segment.

To print this article, all you need is to be registered or login on Mondaq.com. In follow-up to our colleagues recent post about the newly implemented Medical Device Regulation ("MDR") in the European Union, this post will discuss some of the similarities between FDA's Clinical Decision Support ("CDS") Software Draft Guidance (together the "CDS Draft Guidance") and the MDR.  While still in draft form, we note that FDA has signaled its intent to finalize the CDS Draft Guidance in 2021. STATUTORY FRAMEWORK Under the current CDS Draft Guidance, FDA first bases its ...