Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 233: Prioritizing Women’s Health Through Innovation with Lindsey Calcutt of Incora Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 228: Designing & Manufacturing Auto-Injectors with Kimberlee Steele of SHL Medical
Building a Business at the Intersection of Neurodata and Innovation With Rob Cooley
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura Gunter of NCLifeSci
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 208: Extended Reality Technology and the ThinkReality Headset with Mattney Beck of Lenovo
AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson, Neuroscientist, Professor, & Vice President of Research at the Universit
Transparency and the Open Payments Program
Medical Device Legal News with Sam Bernstein: Episode 19
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
Health + Tech - Improving Cancer Care With Digital Health Tools
Medical Device Legal News with Sam Bernstein: Episode 14
The surge in health and wellness devices—including wearables, beauty devices and more—comes a result of consumer interest in preventive health measures. These products offer a range of benefits, from improving skin and...more
FDA’s Warning Letter to WHOOP, a manufacturer of cutting-edge, wellness wearable tech, has sent shivers through an industry enjoying exponential growth in the health and wellness space. “Wellness technology”, a result of the...more
On July 14, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued a warning letter (the “Warning Letter”) to WHOOP, Inc. (“WHOOP”), rejecting WHOOP’s claim that its wearable “Blood Pressure Insights” product...more
On June 24, 2025, in a hearing before the U.S. House of Representatives Committee on Energy and Commerce, the Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr. revealed that his department plans to soon...more
Recorded at SCbio’s 2025 annual conference, hosts Heather and Lauren are joined by Lindsey Calcutt, an award-winning entrepreneur and the CEO and Co-Founder of Incora Health. Lindsey shares how the gap in women’s health...more
As more employers incorporate wearable technology in the workplace, including those enhanced by artificial intelligence, the Equal Employment Opportunity Commission (EEOC)’s new fact sheet “Wearables in the Workplace: The Use...more
The field of women’s health technology (FemTech) is rapidly evolving, and Israel is considered one of the global leaders, ranking fourth worldwide in the number of FemTech companies. Additionally, Israel ranks second in...more
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
Healthcare facilities exposed to pressure injury litigation too often fail to defend patient malpractice claims because they cannot prove that caregivers provided reasonable turning and repositioning to prevent skin breakdown...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
The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) recently unveiled a new website with updated guidance and resources for mobile health app developers regarding the HIPAA Privacy, Security, and...more
Nearly half of Americans have tried wellness wearables or another digital health product. In a global pandemic, can we use the information tracked by wellness wearables to help prevent further spread and infection?...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
In July 2018, Citroën, the French car manufacturer, unveiled glasses that aid in alleviating motion sickness. The “Seetoën” glasses, developed by Boarding Ring, purports to eliminate motion sickness symptoms within about 10...more
Garmin International, Inc. recently announced a collaboration with ActiGraph to create health and activity monitoring solutions for academic research, clinical trials, and remote patient monitoring. The collaboration will...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
Since its first release in 2015, the Apple Watch has continued to evolve and incorporate more health- and fitness-tracking capabilities. The latest version of Apple’s Watch—Series 4—features a larger display screen, thinner...more
Wearable technology and medical devices have vulnerabilities just like anything else that is digital. ICS-CERT recently issued an advisory about vulnerabilities in Medtronic’s MyCareLink patient heart monitors. ...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
In the EU, digital health technologies such as medical apps or wearable sensors can fall within the scope of the medical devices directives. ...more
Digital health is the convergence between healthcare, genomics, and digital technologies. It is a fast-growing sector with important implications for individuals and institutions alike. Whether it is hospitals and health...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
Novocure recently announced final results from a phase III EF-14 clinical trial of its Optune device for treatment of newly diagnosed glioblastoma (GBM)....more
Security firm InfoArmor published a report in late July 2016 stating that a group of attackers infiltrated American health care institutions, stole at least 600,000 patient records and attempted to sell more than 3 terabytes...more
Fitbit, Inc. reported its quarterly results which led to an 10% increase in its share price. The company recently announced that Adam Pellegrini will join the company as Vice President of Digital Health on September 6th....more