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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On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft guidance documents to provide updated recommendations on the 510(k) Program to “keep pace with the increasing...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...
FDA Releases Draft Guidance for Studies of Medical Devices for Opioid Use Disorder
The U.S. Food and Drug Administration (FDA) recently released draft guidance regarding clinical considerations for studies of medical devices intended to treat opioid use disorder (OUD).  According to the FDA’s...
FDA Updates Medical Device Shortages List
The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory Reagents and Testing Supplies, Transport Media Device, Saline Vascular Access Flush, and Certain Ventilation-Related Products. This...
FDA on pace for a Record Number of Breakthrough Devices in 2023
The FDA implemented the breakthrough device program in 2015.  The program was designed to expedite review of premarket approval (PMA), 510(k) clearance, and De Novo marketing authorizations. Applicants can seek...
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,...
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