Digital Health

News & Analysis as of

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

Patent Strategies in the Digital Health Care Space

You are founding a startup with a great new idea to revolutionize a key health care segment, but you know the digital health space is packed with potential competitors. Your technology and first-mover advantage create...more

[Webinar] Digital Health Update: Focus on Health Tech Startups - June 23, 1:00 CDT

Health care startups are expected to attract billions in venture capital in the next few years. Despite the pace and excitement this surge of investment creates, these next-wave digital disruptors need to keep three legal...more

Jawbone and Oscar Lead Record Breaking Month for Digital Health Financings

Two blockbuster deals drove digital health financings to record levels in April. The month saw a total of nearly $790 million in deal flow, with the ten largest financing transactions of the month matching the first quarter...more

Investment in eHealth: 2014, and what the future holds

Digital health, a category that was virtually nonexistent five years ago, has exploded in recent years and shows the potential to remake the way healthcare is delivered worldwide. Rock Health, the digital health incubator,...more

Digital Health Investment Maintains Momentum in 2015

Digital health investment is off to a healthy start in 2015 with our friends at Rock Health reporting more than $630 million invested in the first quarter. Fenwick clients Augmedix and Centrillion Technology Holdings received...more

Alert: Federal Policy Developments Impacting Medical Technology Companies

Health care is always a major issue in Washington, DC but recently how to promote innovation in medtech has become a priority within that conversation. Thus far, 2015 has produced a major legislative initiative in the form of...more

Digital Health Enjoys Tremendous Growth in 2014

What a difference a year makes. Last year, we noted that 2013 was a blockbuster year for digital health investments with almost $2 billion of private capital going into the sector. We highlighted the 10 largest deals of 2013,...more

EU Art. 29 Working Party Letter on Health Data and Apps

The EU Article 29 Working Party (“WP29”) has published a letter to the European Commission (“EC”) on the scope of health data in relation to lifestyle and well-being apps, following the EC’s Working Document on mHealth and...more

Alert: FDA Finalizes Guidance on Devices that Store and Transfer Data

The Food and Drug Administration (FDA) on February 6th, finalized guidance on certain medical devices that store and transfer data, opting for a very light regulatory touch. In its guidance, the FDA states that it doesn't...more

Novartis and Qualcomm Form Digital Health Investment Company

Novartis Pharmaceuticals has announced it has formed a joint investment company with Qualcomm Ventures, the venture investment group of Qualcomm....more

Can Digital Healthcare Innovation Be Patented? Eligibility of Digital Healthcare Technologies Under the New USPTO Eligibility...

Digital healthcare, the confluence of digital technology with medical and other biological fields, has become an ever-increasing presence in our daily lives. Ideas that seemed nearly impossible just a few years ago (such as...more

Digital Health Investors Catch Their Breath in November

Digital health investors seem to have taken a step back to catch their breath in November after 10 months of record-breaking activity. There were only 6 investments in November of $10 million or more and only one for more...more

October Digital Health Investments Dominated by Diagnostics and Therapeutics

Digital health companies raised just over $730 million through venture, private equity and angel investments in September, according to our latest analysis, bringing the total for the third quarter to approximately $1.3...more

Digital Health Investment in September Tops $700 Million

Digital health companies raised just over $730 million through venture, private equity and angel investments in September, according to our latest analysis, bringing the total for the third quarter to approximately $1.3...more

Three Things Tech Titans Have That eHealth Needs

Large tech companies have been virtually lining up to announce their foray into the digital health space recently. Industry analysts have long suspected that an incumbent industry with a strong customer base could come in and...more

FDA Regulatory and Compliance Monthly Recap

Mobile health industry could get a boost as FDA draft guidance exempts certain medical devices, including digital health devices - The FDA’s decision to not require a number of mobile health devices to go through the...more

FDA Advises it Will Not Enforce Regulatory Controls for Low-Risk Medical Information Technology Devices

The U.S. Food and Drug Administration (FDA), in conjunction with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC), recently issued a draft report...more

FDA Issues Draft Guidance Easing Compliance for Medical Device Data and Image Systems

In what has been an active couple of months of released guidance documents, the FDA issued another draft guidance on June 20, 2014 entitled, “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image...more

Connected Health: Capturing Digital Opportunities

Her comment has been echoed by many market participants who have predicted that we are seeing the first wave of large traditional companies leveraging digital platforms and tools to drive growth and innovation. These...more

Digital Health Investments Rebound In April

Private investment in digital health rebounded in April after a lackluster March with more than $924 million in venture capital and private equity going into the sector. That tops the $700 million garnered by the sector in...more

The Life Sciences Report - Spring 2014

In this issue: - A New Accelerator Takes Digital Health Start-Ups to the Next Level - The Return of the MedTech IPO Market - Is There a Deal in Your Future? A Guide to Navigating Antitrust Waters -...more

Top Ten Digital Health Investments Of 2013; Generating Momentum For The Year Ahead

Digital health investing started the year on a high note with four $20+ million rounds of funding in January alone for MD Live, TigerText, MC10 and WellDoc. That’s a very promising continuation of the tremendous funding...more

Digital Health: Revolutionizing Healthcare [Video]

What is digital health? What sort of action is digital health seeing? According to Fenwick client and digital health incubator Rock Health, digital health funding was up 65 percent mid-year in 2012 and up 45 percent over the...more

Who Will Pay For Digital Health Apps?

The question of whether or not smartphone apps can play an important role in the delivery of healthcare services has been more or less answered with a resounding yes. From weight loss to diabetes monitoring to diagnosing ear...more

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