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Updated: Reimbursement Questions Jeopardize Hillrom/Bardy Merger

 
• By Reed Miller

Hillrom is reconsidering its planned $375m acquisition of Bardy Diagnostics because of Novitas' plan to cut Medicare reimbursement for extended cardiac monitoring. Bardy is suing to complete the deal.

Business deal failure concept as two businessmen on a road bridge that is breaking down and disconnecting
• Source: shutterstock.com

[Update: On 12 July, the Delaware Court of Chancery ordered Hillrom to proceed with its proposed acquisition of Bardy Diagnostics, denying Hillrom's claim of a Material Adverse Event under the terms of the acquisition agreement. The companies completed the deal on 6 August, making Bardy a wholly owned subsidiary of Hillrom.

"Following the Delaware Court of Chancery’s Ruling two weeks ago, we thoroughly explored and assessed a variety of strategic options....

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FDA Document Request Denied As Case Against SurModics Merger Intensifies

 
• By Elizabeth Orr

A federal court in Illinois ruled against SurModics and BC Holdings' request for FDA documents to support a proposed merger. The FTC has challenged the merger, claiming it threatens competition in hydrophilic device coatings. The ruling may indicate the FTC is likely to succeed.

Former Top OIG Attorney Gives Inside Look At Fraud Prevention

 
• By Elizabeth Orr

Former HHS-OIG attorney Rob DeConti emphasized the significance of data analytics and compliance in combating healthcare fraud, urging medical tech companies to adopt robust measures to prevent potential risks.

DME And Diagnostics In Crosshairs As DOJ ‘Follows The Money’

 
• By Elizabeth Orr

The DOJ has launched nearly 70 enforcement actions in 2025, targeting diagnostics, durable medical equipment, and telehealth fraud. Key cases involve significant fraudulent claims against Medicare, with individuals facing severe penalties.

Mexico’s New Procurement Rules Aim To Increase Healthcare Investment, But May Face Legal Trouble

 
• By Francesca Bruce

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.

More from Policy & Regulation

Injuries And Deaths Linked To Baxter Infusion Pump

 
• By Brian Bossetta

The US FDA says Baxter has notified customers about an issue with its Novum IQ Syringe Pump that is linked to two deaths and multiple injuries.

Bates To Energize UK Office For Life Sciences

 
• By Ashley Yeo

Steve Bates, head of the UK BioIndustry Association, has been appointed executive chair of the government’s Office for Life Sciences as the UK restructures its life sciences approach and drives health outcomes with a new NHS Long-Term Care plan.

International Reliance Gets UK MHRA OK In Drive For Agile Pre-Market Regulation – CE Marking Next

 
• By Ashley Yeo

The UK government’s response to MHRA public consultation on risk proportionate device routes to market and physical UKCA markings adds momentum to drive for modern, agile system. Another consultation in late 2025 will propose indefinite recognition of CE-marked devices in Great Britain.