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Medical Devices & Procedures
Blog
FDA Releases Draft Guidances on 510(k) Submissions
|Paige L. Cappelli
On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft guidance documents to provide updated recommendations on t...
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Medical Devices & Procedures
Blog
Medtronic Sued for Allegedly Sharing Health Info With Google
|Eric Wittgrove
Medtronic Minimed, Inc. and Minimed Distribution Corp. (“Medtronic”) were sued in a class action complaint in the Central District of California on...
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Medical Devices & Procedures
Blog
FDA Issues Updated Informed Consent Guidance for Clinical Investigatio...
|Nima Zargari, Ph.D.
On August 15, 2023, the Food and Drug Administration (FDA) issued its updated guidance on informed consent for clinical investigations. The FDA’s ...
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Medical Devices & Procedures
Blog
Venture Capitalist Funding in Medtech Increasing
|Christopher L. Lewis
Recent reports, including one by PitchBook, indicate that both venture capitalist funding for medtech companies and the variety of medtech companie...
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Medical Devices & Procedures
Blog
Navigating the Regulatory Landscape: FDA Approval and Patent Protectio...
|Kenneth O. Aruda, Ph.D.
Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, devel...
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Medical Devices & Procedures
Blog
FDA Statements and Patent Disclosures
|Philip M. Nelson
Medical Device companies often need the U.S. Food and Drug Administration (FDA) to approve “indications for use” of their products–for use selling ...
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Medical Devices & Procedures
Blog
FDA Releases Draft Guidance for Studies of Medical Devices for Opioid ...
|Joshua C. Loader
The U.S. Food and Drug Administration (FDA) recently released draft guidance regarding clinical considerations for studies of medical devices inten...
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Medical Devices & Procedures
Blog
FDA Updates Medical Device Shortages List
|Arash Pia
The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory Reagents and Testing Supplies, Transport Media Devi...
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Medical Devices & Procedures
Blog
FDA on Pace for a Record Number of Breakthrough Devices in 2023
|Zachary B. Messick
The FDA implemented the breakthrough device program in 2015. The program was designed to expedite review of premarket approval (PMA), 510(k) clear...
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Medical Devices & Procedures
Blog
Federal Circuit Vacates PTAB’s Decisions in Axonics, Inc. v. Medtronic...
|Rory R. Lootsma
Sacral neuromodulation stimulates nerves above the tailbone to treat fetal incontinence and related bowel and bladder control issues. After Calif...
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Medical Devices & Procedures
Blog
Is FDA Approval for Renal Denervation on the Horizon?
|Michael R. Christensen
On August 22-23, 2023, the FDA will conduct an Advisory Committee Meeting to discuss, make recommendations, and vote on renal denervation devices (...
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Medical Devices & Procedures
Blog
Presidio Medical Raises $72 Million for ULF Neuromodulation Platform
|Matthew S. Whitehead
Presidio Medical, Inc. announced that the company successfully concluded a Series C funding round, raising a total of $72 million. The round was le...
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