Getting Personal—Wearable Devices, Data, and Compliance
I-24 – Thankful for Volume 1, 2017, and Relationships
The Intersection of Wearable Technology and the Insurance Industry
The Increasing Visibility of Driver Health
The Ever-Expanding Scope of Social Media Discovery
Wearables and the Future of Intellectual Property Law
What is Graphene? Fenwick Patent Attorney Has the Answer
In a recent blog post, Fitbit unveiled three new devices in its product line. One of the newly debuted watches, the Sense 2, includes an atrial fibrillation (AFib) detection algorithm that recently received FDA clearance....more
Is 3D printing the next litigation frontier? Litigation over 3D printing will become increasingly more prevalent as the technology becomes less expensive to build due to rising demand, some lawyers say. A federal court in...more
On September 22, the U.S. Food and Drug Administration (FDA) announced the launch of its Digital Health Center of Excellence within the Center for Devices and Radiological Health. The FDA called this an important step toward...more
Manufacturers of activity trackers and smartwatches have been fighting over the “serious” healthcare market for several years. Companies such as Apple (previously discussed here), Fitbit (previously discussed here), and...more
This follows the blog article posted November 28, “Connection and Innovation Take Center Stage at the Patient ENGAGE Conference” and is the second feature regarding the MedCity ENGAGE conference Nov. 6-7 in San Diego. Here,...more
Senseonics recently received Premarket Approval from the Food and Drug Administration (FDA) for its Eversense® Continuous Glucose Monitoring (CGM) System. According to Senseonics, the Eversense® CGM System is the first and...more
Fitbit recently announced plans to build sleep apnea diagnostics into its wrist-worn activity tracking devices, stating that it expects do so within a year. If successful, Fitbit may be able to address a market that is...more
The Vulnerability of Healthcare Information - According to a report the Brookings Institute issued in May 2016, 23% of all data breaches occur in the healthcare industry. Nearly 90% of healthcare organizations had some...more
3D printer shipments in U.S. jump 20% in 2015: IDC - International Data Corp (IDC) research found 3D printer shipments in the U.S. grew by almost 20% in 2015 compared to 2014. Looking ahead, 3D printer shipments in the...more
Wearable devices, such as fitness trackers and smart watches, have taken the United States technology industry by storm. In the past three years, there has been a 500% increase in the number of fitness bands and activity...more
Amid myriad media reports about potential vulnerabilities in medical device cybersecurity and the FDA’s efforts to strengthen medical device cybersecurity, the IEEE Cybersecurity Initiative released a report entitled...more
The medical device market is expanding into more private healthcare products in hopes of bringing healthcare directly to the user. For example, the increase in popularity of wearable diagnostic devices, such as FitBit,...more
Background - On January 20, 2015, the U.S. Food and Drug Administration (FDA or the Agency) announced the availability of two draft guidance documents in the Federal Register: “General Wellness: Policy for Low Risk...more
On January 16, 2015, the Food and Drug Administration (FDA) promulgated a much - anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest...more
On January 20, 2015, the FDA issued draft guidelines designed to give developers whose products and applications promote healthy lifestyles (so-called “general wellness products”) direction on when such products qualify as...more