Johnson & Johnson recently announced an agreement to acquire Abbott Medical Optics for $4.325 billion. Abbot Medical Optics, a subsidiary of Abbot Laboratories, reported $1.1 billion in sales in 2015. According to the press...more
The Food and Drug Administration published a Final Rule in the Federal Register revising labeling regulations for medical devices and certain biological products to allow for the use of symbols without adjacent explanatory...more
7/7/2016
/ Biologics ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food and Drug Modernization Act ,
International Harmonization ,
Labeling ,
Manufacturers ,
Medical Devices ,
Product Labels ,
Warning Labels
The Food and Drug Administration published a Proposed Rule in the Federal Register establishing a docket and requesting information and comments on third party entities that “refurbish, recondition, rebuild, remarket,...more
Medtronic, a medical device manufacturer based in Dublin, Ireland, recently announced FDA approval and U.S. commercial launch of its MyCareLink Smart Monitor, the first app-based remote monitoring system for implantable...more
The Patent Trial and Appeal Board (“PTAB”) denied a petition by C.R. Bard, Inc. requesting inter partes review of claims 1 and 2 of U.S. Patent No. 8,488,786, entitled “Catheter Tray, Packaging System, Instruction Insert, and...more
On May 19, 2015, Molex Incorporated announced that Molex Ireland Holdings B.V. has acquired ProTek Medical Ltd. According to the press release, ProTek Medical, based in Sligo, Ireland, specializes in cleanroom injection...more
On April 2, 2015, the United States Department of Justice announced that Medtronic, a medical device manufacturer based in Ireland, reached a settlement agreement with the United States government for $4.41 million over...more
Four Mile Bay, LLC recently sued Zimmer Holdings, Inc. in the United States District Court for the Northern District of Indiana. The complaint alleges that Zimmer Holdings’ hip implants, such as the “Trabecular Metal Primary...more