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FTC Tells Medtronic To Sell Intersect ENT Subsidiary To Avoid Monopoly

 
• By Elizabeth Orr

The move removes all regulatory roadblocks to Medtronic’s $1.1bn acquisition of Intersect ENT, which was announced in August 2021.

FTC building, Washinton, DC / USA - April 22 2019: The north facade of the Federal Trade Commission building with carved sculpture above an enterence.
• Source: Shutterstock

[Editor's Note: On 30 June, the US Federal Trade Commission approved a final orderresolving the antitrust issues raised in Medtronic's acquisition of Intersect. Hemostasis closed the acquisition of Fiagon on 13 May.]

Medtronic plc has agreed to sell Fiagon AG, a subsidiary of Intersect ENT that makes ear, nose,...

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More from Regulation

FDA Publishes Final Cybersecurity Guidance To Replace Final Cybersecurity Guidance

 
• By Brian Bossetta

The US FDA has issued an updated final guidance document on cybersecurity considerations for medical device manufacturers that replaces a previous final guidance the agency issued in 2023.

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New EU Rules Limit Chinese Participation In Medtech Procurement

 
• By Amanda Maxwell

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FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 
• By Natasha Barrow

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More from Policy & Regulation

New Draft Guidance Clarifies FDA’s UDI Rules For Combination Products

 
• By Elizabeth Orr

The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products. The document specifies labeling requirements and makes recommendations to reduce confusion between UDIs and NDCs. Comments are being accepted until Sept. 24.

European Commission Asks For ‘Open Minds’ On Unified Drug/Device Research Pathway

 
• By Vibha Sharma

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

FDA Publishes Final Cybersecurity Guidance To Replace Final Cybersecurity Guidance

 
• By Brian Bossetta

The US FDA has issued an updated final guidance document on cybersecurity considerations for medical device manufacturers that replaces a previous final guidance the agency issued in 2023.