Federal Circuit Vacates PTAB’s Decisions in Axonics, Inc. v. Medtronic, Inc.
Sacral neuromodulation stimulates nerves above the tailbone to treat fetal incontinence and related bowel and bladder control issues. After California-based Axonics Inc. (“Axonics”) entered the sacral neuromodulation market in late 2019,...
Is FDA Approval for Renal Denervation on the Horizon?
On August 22-23, 2023, the FDA will conduct an Advisory Committee Meeting to discuss, make recommendations, and vote on renal denervation devices (e.g., devices indicated to reduce blood pressure in...
Presidio Medical Raises $72 Million for ULF Neuromodulation Platform
Presidio Medical, Inc. announced that the company successfully concluded a Series C funding round, raising a total of $72 million. The round was led by Deerfield Management, Invus Opportunities, Action...
Left Atrial Appendage Occlusion Device Maker Conformal Medical Raises $35 Million in Oversubscribed Series D Round
On June 5, 2023, Conformal Medical Inc., developer of a left atrial appendage occlusion system, announced a successful Series D funding round, raising a total of $35 million. The round...
FDA Approves Neuralink to Begin Human Trials of Brain Implants
Neuralink, the biotechnology company founded by Elon Musk, has received approval from the U.S. Food and Drug Administration (FDA) to commence human trials of its implantable brain-computer interface device. Recruitment...
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...
