Device Exec Charged With COVID-19 Securities Fraud

The CEO allegedly falsely told investors that the company was closing in on FDA clearance for a rapid-detection COVID-19 test.

Lady justice, themis, statue of justice on books background.

A diagnostics company executive is facing federal fraud charges for allegedly bilking investors out of millions by falsely stating that the company was developing a breakthrough test for COVID-19, the US Department of Justice announced recently.

Keith Berman, CEO of Decision Diagnostics Inc., was charged with one count of securities fraud and one count of making...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Legal & IP

FDA Ends Effort To Regulate LDTs By Rescinding Final Rule

 

Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.

FTC Blocks Edwards Lifesciences’ Merger With JenaValve

 
• By 

The FTC is suing to block Edwards Lifesciences' purchase of JenaValve, citing concerns that it would reduce competition and innovation in the heart valve market and negatively impact patient access to vital treatments for aortic regurgitation. Edwards disagrees with the decision.

Trump Taps Food And Drug Law Outsider For FDA Chief Counsel

 

Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.

FDA Document Request Denied As Case Against SurModics Merger Intensifies

 
• By 

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.

More from Policy & Regulation

Biden-Era Device Trial Snapshot Pilot Halted Amid DEI Policy Shift

 
• By 

The FDA's Device Clinical Trial Snapshot Pilot, aimed at increasing trial transparency and diversity, has been canceled following President Trump’s anti-DEI executive order. Critics warn this may hinder trial transparency, impacting public health and demographic data accessibility.

Warning Letters - July 2025

The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.

Brazil’s Medtechs Look To Solutions After 50% US Tariff Hit Amid ‘Scenario Of Uncertainty’

 

Hopes that last-minute negotiations might exempt Brazil’s $300m medtech exports from the latest round of US tariffs have been dashed, leaving the industry braced for further market instability that countermeasures could trigger.