FDA Releases Draft Guidances on 510(k) Submissions
Knobbe Medical | Medical Device Blog
by Paige Cappelli
6M ago
On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft guidance documents to provide updated recommendations on the 510(k) Program to “keep pace with the increasing complexity of rapidly evolving technology.” As stated on the FDA website: “[E]ach person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless” the device meets certain limited exemptions. A 510(k) submission provides, for the FDA’s review, safety and effectiveness d ..read more
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Medtronic Sued for Allegedly Sharing Health Info with Google
Knobbe Medical | Medical Device Blog
by Eric Wittgrove
7M ago
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® system.  The lawsuit alleges that Medtronic engaged in “transmission and disclosure of Plaintiff’s and Class Members’ personally identifiable information (‘PII’) and protected health information (‘PHI’) [collectively, ‘Private Information’]… to Google[] and other third parties via tracking and authentication technologies – including Google Analytics (and others).” The InPen® system, as described ..read more
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FDA Issues Updated Informed Consent Guidance for Clinical Investigations
Knobbe Medical | Medical Device Blog
by Nima Zargari
7M ago
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 IRBs, Clinical Investigators, and Sponsors.  Informed consent enables prospective subjects to understand the relevant information concerning a clinical investigation while also providing them the opportunity to pose questions, deliberate on participation, and grant voluntary agreement.  The guidance emphasizes the continuation of information dissemination throughout the investig ..read more
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Venture Capitalist Funding in Medtech Increasing
Knobbe Medical | Medical Device Blog
by Christopher Lewis
7M ago
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 quarter of 2023.  While venture capitalist funding for medtech companies is currently predicted to remain below the funding levels seen in 2022 and the record funding levels seen in 2021, reports suggest that venture capitalists are intrigued by new technologies in the medtech space and reports predict that investors may return to the medtech space.  Jeremy Sohn, managing ..read more
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Navigating the Regulatory Landscape: FDA Approval and Patent Protection for Software as a Medical Device
Knobbe Medical | Medical Device Blog
by Kenneth Aruda
7M ago
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 evolving regulatory frameworks. Regulatory frameworks can complicate the already complex problem of innovation in software and can often run roughshod over the distinctions between software, artificial intelligence, machine learning, and deep learning. Development in each of these areas is known to progress in leaps and pauses and can occur at any point from data collection to testin ..read more
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FDA Statements and Patent Disclosures
Knobbe Medical | Medical Device Blog
by Philip Nelson
8M ago
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 seek U.S. patent protection so that they can profit from their inventions underlying those same products.  In both cases, the companies seek to persuade federal government agencies to approve their requests.  However, at a high level, these requests can seem to conflict.  For example, many times a company will seek to persuade the FDA that the product for which approval is sought is si ..read more
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FDA on pace for a Record Number of Breakthrough Devices in 2023
Knobbe Medical | Medical Device Blog
by Zachary Messick
8M ago
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 a breakthrough device designation prior to requesting market approval regardless of the classification of the device.  In order to qualify as a breakthrough device, the device must (1) provide for a more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition and (2) meet at least one of: (a) represents a breakthrough technology ..read more
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Federal Circuit Vacates PTAB’s Decisions in Axonics, Inc. v. Medtronic, Inc.
Knobbe Medical | Medical Device Blog
by Rory Lootsma
9M ago
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, MedTronic sued for patent infringement.  Axonics filed for inter partes review (IPR) of the asserted patents at the Patent Trial and Appeal Board (PTAB).  Although MedTronic initially prevailed in the IPR, Axonics has now succeeded on appeal at the Federal Circuit. Medtronic’s two patents–U.S. Patent No. 8,626,314, titled “Implantable Medi ..read more
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Is FDA Approval for Renal Denervation on the Horizon?
Knobbe Medical | Medical Device Blog
by Michael Christensen
9M ago
On August 22-23, 2023, the FDA will conduct an Advisory Committee Meeting to discuss, make recommendations, and vote on renal denervation devices (e.g., devices indicated to reduce blood pressure in patients with hypertension).  On August 22, the Advisory Committee will discuss the Paradise Ultrasound Renal Denervation System by ReCor Medical, a wholly-owned subsidiary of Otsuka Medical Devices Co., Ltd.  The following day, the Advisory Committee will discuss the Symplicity Spyral Renal Denervation System by Medtronic, Inc..  According to the FDA’s meeting announcement, such adv ..read more
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Presidio Medical Raises $72 Million for ULF Neuromodulation Platform
Knobbe Medical | Medical Device Blog
by Matthew Whitehead
9M ago
Presidio Medical, Inc. announced that the company successfully concluded a Series C funding round, raising a total of $72 million. The round was led by Deerfield Management, Invus Opportunities, Action Potential Venture Capital, and ShangBay Capital. David Neustaedter, venture partner at Deerfield, joined Presidio’s board in connection with the financing. Presidio Medical is a clinical-stage medical technology company that is developing a Ultra Low Frequency (ULF) neuromodulation platform. In ULF neuromodulation electrons stimulate nerves with electrical current and enable controlled and rever ..read more
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