![[video] Digital Health Innovators: Does your solution qualify as Software as a Medical Device (SaMD)?](https://images.squarespace-cdn.com/content/v1/563c7acce4b028323896cb89/1630919850100-SJ68VGMR0T2FN758NSE0/SaMD+for+RPM+and+RTM_blog+image_NGL.png)
If you’re in the Remote Patient Monitoring (RPM) or Remote Therapeutic Monitoring (RTM) space, then you’ll want to understand the criteria and opportunities for qualifying as Software as a Medical Device (SaMD)
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![[VIDEO] How we think about Healthcare Innovation and what we're seeing in the market right now](https://images.squarespace-cdn.com/content/v1/563c7acce4b028323896cb89/1618507063514-XTZGRXEZNWAA36P9AT3H/Partner+vlog+ep2_blog+image_NGL.png)
We’re inviting you back for a bit of our weekly Partner meeting. This time we’re talking about Healthcare Innovation—what it is, the kind of innovative companies we’re seeing in the market, and what they’re doing that you should know about.
This conversation is especially relevant for those of you looking for emerging trends which may impact the market. (And hey, isn’t that everyone?)
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2020 was the year that showed us all that you can’t truly predict what lays ahead. But, for all the surprises of the last year, the industry didn’t collapse, it accelerated along familiar trend lines. So, after a year like 2020, should we even attempt to predict what will happen in 2021? We say yes. And here’s why…
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Welcome to January 2020! I am Tommy Miller, I am Senior Counsel, and life science practice lead here at Nixon Law Group. Today I want to walk you through what I think are the highs and lows of 2019, specifically related to the legislative and regulatory actions taken in the pharmaceutical and medical device space.
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Despite division along party lines and industry pushback, the House of Representatives has passed legislation (H.R. 3), the “Lower Drug Costs Now Act”, which would require the Department of Health and Human Services (DHHS) to establish a “Fair Price Negotiation Program” responsible for negotiating Medicare payments for some of the most expensive drugs available to Medicare beneficiaries.
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When developing new medical device and drug products, it is important to understand how the product will be adopted and paid for in the marketplace. The development of new drugs and devices involves countless hours researching, testing, modifying, iterating, and testing some more… In larger companies, whole teams of people also dedicate the same effort into developing a market access plan—meaning careful planning for manufacturing, distribution, and insurance contracting. This strategic planning can be overlooked in start-up biotech companies operating on limited resources and which are squarely focused on innovating new technologies.
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The FDA has just issued four final guidance documents related to the 510(k) clearance applications for medical devices. The Guidance documents can be found here, and they describe the FDA’s current thinking on special 510(k) clearance programs such as the Abbreviated application and the newly established “Special 510(k)” program.
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Hospitals and medical device manufacturers will both benefit from the Centers for Medicare and Medicaid Services’ (CMS) finalization of the 2020 Inpatient Prospective Payment System (IPPS) Final Rule (“Final Rule”) scheduled to be published on August 16, 2019. In an effort to increase Medicare beneficiaries’ access to innovative medical technologies, CMS has finalized certain changes to the “new technology add-on payment” “(NTAP) application and payment processes under the Final Rule. This change is likely to encourage hospital adoption of new technologies, which is intended to spur innovation and additional investment in these technologies.
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