FDA Clears Sonic DL™ for Cardiac MRI Scans
On June 5, 2023, GE HealthCare announced the FDA 510(k) clearance of Sonic DL™. GE HealthCare reports that Sonic DL™ is a deep learning-based technology intended to capture cardiac MRI...
FDA Updates Cybersecurity Guidance
By Matthew Ruth (May 30, 2023) Going forward, medical device approval will require the device maker to provide cybersecurity information to the FDA. Congress made this change by adding Section 524B...
Brain Computer Interface Developer Announces $33M Series A, Granted FDA “Breakthrough” Designation
Brain computer interface developer Paradromics on May 18, 2023, announced a $33 million Series A funding round as well as a “Breakthrough Device Designation” from the FDA. The funding is...
DuPont to Acquire Spectrum Plastics Group
DuPont announced on May 2, 2023 its acquisition of Spectrum Plastics Group (“Spectrum”), a specialty plastics manufacturer, from the private equity firm AEA Investors for $1.75 billion. Headquartered in Atlanta,...
Security Defense Systems Sues Athenahealth and ConnectiveRx
On April 26, 2023, Security Defense Systems, LLC sued Athenahealth, Inc. in the Western District of Texas. The lawsuit alleges that Athenahealth’s Epocrates application and epocrates.com website infringe U.S. Patent...
AI & the FDA
The use of artificial intelligence (AI) in healthcare has been growing rapidly in recent years, and AI-enabled medical devices are playing a larger role in patient care. Such devices may...
Cranial Technologies Sues Ottobock for Infringement of Cranial Remodeling Patents
Cranial Technologies, Inc. sued Ottobock SE & Co. KGaA and Active Life LLC in the U.S. District Court for the Central District of California on March 29, 2023. The lawsuit...
FDA Issues Final Guidance on Transitioning from COVID-19 EUAs
The FDA recently announced release of final transition guidance documents for medical diagnostic devices targeting COVID-19. The transition guidance documents are intended to guide COVID-19 diagnostic device manufactures as their devices transition...
NVIDIA Collaborates with Medtronic to Build AI Platform for Endoscopy Devices
NVIDIA collaborates with Medtronic to integrate NVIDIA’s artificial intelligence (AI) technology into Medtronic’s GI Genius Endoscopy Module.
FDA Seeks $7.2 Billion Budget for 2024
The FDA recently announced that it is seeking a budget of $7.2 Billion for 2024, part of which is intended for “Advancing Medical Product Availability.” The portion of the requested...
Health Tracker Systems Alleges Garmin’s Smartwatch Infringes Patents
Health Tracker Systems LLC (“Health Tracker”) sued Garmin International, Inc. (“Garmin”) for patent infringement in the Central District of California on March 6, 2023. The lawsuit alleges that Garmin’s Forerunner...
Patent on Controlling Access to Drug Delisted from Orange Book
On February 24, 2023, in Jazz Pharms., Inc., v. Avadel CNS Pharms., LLC, the U.S. Court of Appeals for the Federal Circuit affirmed the United States District Court for the District of Delaware’s...
