Medical Device Lawsuit Alerts
- Petition for Inter Partes Review by Absolute Dental Services, Inc. c/o its Attorney Ryan K. Simmons, Esq., Reg. 45848 of Watson Guide IP, LLC’s U.S. Patent No. 11,173,016 (Inter Partes Review Denied)
- Petition for Inter Partes Review by Fusion Orthopedics, LLC of Extremity Medical, LLC’s U.S. Patent No. 11,298,166
- Petition for Inter Partes Review by Life Spine, Inc. of Globus Medical, Inc.’s U.S. Patent No. 10,925,752 (Inter Partes Review Denied)
- Petition for Inter Partes Review by Life Spine, Inc. of Globus Medical, Inc.’s U.S. Patent No. 10,137,001 (Inter Partes Review Instituted)
- Petitions for Inter Partes Review by Life Spine, Inc. of Globus Medical, Inc.’s U.S. Patent No. 8,845,732 (Inter Partes Reviews Instituted)
Recent Medical Device News
- Siemens to acquire Varian for $16.4 Billion
- Presidio Medical Announces $30 Million Financing Round Led by Invus Opportunities
- Polares Medical Closes a $40M Financing to Complete Pilot Clinical Studies
- CVRx Raises $50 Million in New Equity Financing
- Medtronic Makes Offer for Medical Device Maker Intersect
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 to the Federal Food, Drug, and Cosmetic Act (FD&C Act) at the end of 2022, addressing concerns over the cybersecurity of medical devices. Risks from cybersecurity incidents involving medical devices may include "Health Insurance Portability and Accountability Act (HIPAA) violations, improper patient health assessments, miscalculated medication dosages, and other potentially fatal outcomes,...