PREVAIL Act Proposes Significant Changes To PTAB Proceedings
IP rights can be vital to the success of medical device companies. Significant legislative changes governing some of these rights may be on the horizon. Senators Coons (Delaware), Durbin (Illinois), Hirono...
Updates in the FDA’s Regulation of Digital Health Technologies
The FDA issued a warning letter to Abiomed, for failing to seek approval for its Impella Connect System software before putting it on the market. The Impella Connect System software...
Enovis Corp. Acquires LimaCorporate for $846 Million
Enovis Corporation (“Enovis”) announced on September 25, 2023, that it has agreed to acquire LimaCorporate S.p.A (“LimaCorporate”). Enovis is a medical device company specializing in orthopedics. It offers a wide...
Haemonetics Corporation Acquires OpSens, Inc.
Haemonetics Corporation announced on October 10th that it would be acquiring OpSens, Inc. The deal between the companies is expected to close by the end of January 2024, according to...
Shutdown will Impact FDA
The looming government shutdown will likely slow the pace of work at the FDA. The federal government will shut down on October 1, 2023 unless a deal is reached. In the event...
Major Med Device Product Developer GE HealthCare Collaborating with Healthcare Providers
For good reasons, including product safety, quality assurance, development of delivery procedures and instructions, it has been a common practice for medical device companies and innovators to consult with physicians...
FDA Releases Draft Guidances on 510(k) Submissions
On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft guidance documents to provide updated recommendations on the 510(k) Program to “keep pace with the increasing...
Medtronic Sued for Allegedly Sharing Health Info with Google
Medtronic Minimed, Inc. and Minimed Distribution Corp. (“Medtronic”) were sued in a class action complaint in the Central District of California on August 30, 2023, by users of Medtronic’s InPen®...
FDA Issues Updated Informed Consent Guidance for Clinical Investigations
On August 15, 2023, the Food and Drug Administration (FDA) issued its updated guidance on informed consent for clinical investigations. The FDA’s updated guidance is titled Informed Consent Guidance for...
Venture Capitalist Funding in Medtech Increasing
Recent reports, including one by PitchBook, indicate that both venture capitalist funding for medtech companies and the variety of medtech companies receiving venture capitalist funding has increased since the first...
Navigating the Regulatory Landscape: FDA Clearance and Patent Protection for Software as a Medical Device
Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves navigating complex and...
FDA Statements and Patent Disclosures
Medical Device companies often need the U.S. Food and Drug Administration (FDA) to approve “indications for use” of their products–for use selling them in the U.S. Those same companies often...
