U.S. Tariffs and the Medical Device Industry
As of April 24, 2025, the United States has imposed tariffs on over 180 countries and territories. This includes a universal 10% baseline tariff while larger tariffs are in a...
Global Market Size and Technological Advancements for Implantable Medical Devices Continue to Grow
A recent report by Precedence Research estimates the global market size for implantable medical devices will grow from USD 97.62 Billion in 2024 to USD 178.15 Billion by 2034: The...
Zimmer Biomet to Acquire Paragon 28
Zimmer Biomet recently announced entering a definitive agreement to acquire all outstanding common shares of Paragon 28. Under the agreement, Zimmer Biomet will pay $13.00 per share, valuing Paragon 28...
FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development
The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product...
Stryker Agrees to Acquire Inari Medical for $4.9 Billion
Stryker Corporation (“Stryker”) recently announced entering into a definitive agreement to acquire Inari Medical, Inc. (“Inari”) for approximately $4.9 billion. Inari develops technologies and products for treating pulmonary embolism, deep...
Cook Medical Sells Lead Management Portfolio to Merit Medical
Cook Medical recently announced it is selling its lead management portfolio to Merit Medical. Cook Medical is a medical device manufacturer with a portfolio of products used in lead management...
ARPA-H Announces New Funding related to AI-Enabled Medical Tools
The U.S. Advanced Research Projects Agency for Health (ARPA-H) announced new funding for a “program to help AI-enabled medical tools maintain peak performance.” The new funding is through the Performance and...
Boston Scientific Agrees to Acquire Silk Road Medical in $1.16B Deal
Press releases report that Boston Scientific (BSX) has entered an agreement to acquire medical device developer Silk Road Medical in a deal totaling $1.16 billion. Silk Road Medical has reportedly...
3M Spins Off Healthcare Business Solventum
3M recently completed the spinoff of its healthcare technology business as the new standalone public company, Solventum Corporation. Solventum has an IP portfolio with over 7,300 patents globally. Solventum operates...
Expect Future FDA Clarification on Machine Learning-Enabled Medical Devices
The inaugural AAMI/FDA neXus medical device standards conference was held February 20-23, 2024 in Washington DC. The conference was hosted by the Association for the Advancement of Medical Instrumentation (AAMI)....
FDA Approves Edwards EVOQUE® Tricuspid Valve Replacement System
The U.S. Food and Drug Administration (“FDA”) recently approved the Edwards EVOQUE® Tricuspid Valve Replacement System (the “EVOQUE® system”) for use in treating Tricuspid Regurgitation (“TR”). The EVOQUE® system is...
FDA Clears ABK Biomedical’s Eye90 Microspheres for Hepatocellular Carcinoma Treatment
ABK Biomedical successfully secured Breakthrough Device Designation from the FDA on December 5, 2023, for its Eye90 microspheres device, which is indicated for the treatment of unresectable Hepatocellular Carcinoma (HCC)....
CooperCompanies acquires a selection of Cook Medical’s reproductive health products
CooperCompanies announced on November 1, 2023, the purchase of Cook Medical’s doppler monitoring, gynecology surgery, and obstetrics products for $300 million. CooperCompanies is a global medical device company that is...
FDA Clears Neurovalens’s Modius Sleep for Insomnia Treatment
Neurovalens successfully secured 510(k) clearance from the FDA on October 27, 2023 for its Modius Sleep device with relation to treatment of insomnia and/or anxiety. The clearance was supported by...
DuPont to Acquire Spectrum Plastics Group
DuPont announced on May 2, 2023 its acquisition of Spectrum Plastics Group (“Spectrum”), a specialty plastics manufacturer, from the private equity firm AEA Investors for $1.75 billion. Headquartered in Atlanta,...
Security Defense Systems Sues Athenahealth and ConnectiveRx
On April 26, 2023, Security Defense Systems, LLC sued Athenahealth, Inc. in the Western District of Texas. The lawsuit alleges that Athenahealth’s Epocrates application and epocrates.com website infringe U.S. Patent...
Cranial Technologies Sues Ottobock for Infringement of Cranial Remodeling Patents
Cranial Technologies, Inc. sued Ottobock SE & Co. KGaA and Active Life LLC in the U.S. District Court for the Central District of California on March 29, 2023. The lawsuit...
FDA Seeks $7.2 Billion Budget for 2024
The FDA recently announced that it is seeking a budget of $7.2 Billion for 2024, part of which is intended for “Advancing Medical Product Availability.” The portion of the requested...
Medical device innovations and IP: A strategy is everything.
Bringing a medical device to market relies on a broad understanding of IP, explain Sabing Lee and Kregg Koch of Knobbe Martens. The original version of this article was published...
Becton Dickinson’s PureWick Wins Patent Infringement Suit Against Stryker’s Sage Products Related To Female External Catheters
PureWick Corp., a Becton Dickinson company, succeeded in its infringement lawsuit PureWick Corp. v. Sage Products LLC. PureWick’s lawsuit alleged that Sage Products infringed U.S. Patent Nos. 10,226,376; 10,390,989; 10,376,407,...
Medical Device Company Pleads Guilty to Dealing in Non-FDA Approved Devices
The United States Department of Justice announced that medical device company Affordable Healthcare Solutions, LLC has pleaded guilty to charges related to unapproved prescription hyaluronic acid medical devices, as reported...
