Imaging manufacturer pays $18M to settle whistleblower suit; GE’s FDA win, plus more vendor news

Merit Medical Systems has finalized a deal to pay the feds $18 million to settle a whistleblower’s lawsuit, the imaging manufacturer announced Tuesday.

The Department of Justice had joined the legal battle back in June, accusing the Utah-based firm of paying kickbacks to entice doc to use its interventional radiology and other products. Leaders have not admitted any wrongdoing and the pact “expressly recognizes” that it denies the allegations.

“In order to avoid distraction from its core mission, and the cost of litigating the matter to success, Merit agreed to pay $18 million to the federal government and certain states,” the firm said in its Oct. 13 announcement.

Former employee Charles Wolf, MD, first surfaced the allegations and stands to collect a share of the payout. Founded in 1987, Merit dubs itself as a “leading” manufacturer and marketer of disposable devices used in interventional and diagnostic radiology, cardiology and other specialties.

GE’s AI upgrade

GE Healthcare recently earned U.S. Food and Drug Administration clearance for an ultrasound system addition, which harnesses artificial intelligence to help docs acquire images faster and more consistently.

Assessing heart function via echocardiography can be a tedious and time-consuming process, the Chicago-based company noted. But GE’s new Vivid Ultra Edition can help to boost efficiency during the process, with 80% fewer clicks, 99% accuracy and less variability between operators.

The product is able to do so by leveraging AI-driven, neural network-based algorithms aimed at delivering repeatable and faster measurements in 2D echo imaging, GE said Monday.

Vendor’s new talk show

Radiology vendor Carestream Health is planning to launch a new web-based talk show later this month, with the first episode exploring bedside imaging.

The Rochester, New York-based company’s new series will premiere on Oct. 28, with each 15- to 20-minute episode exploring a new topic. “Carestream Talks,” as they’ve dubbed it, will be pre-recorded but feature a live Q&A session afterward, the company announced Wednesday.

PACs partnership grows

Cloud-based imaging management vendor Ambra Health is expanding its partnership with Rad-Aid aimed at reducing disparities in imaging, the two companies announced on Tuesday.

Rad-Aid currently deploys more than 12,000 volunteers serving 80 hospitals in 35 countries. Its mission is to help support radiology services in resource-poor communities via training, equipment implantation and technology.

The two have combined to form the Rad-Aid Friendship Cloud, helping providers to more easily adopt imaging technology. The partnership to date has impacted roughly 160,000 radiology cases in Guyana, Laos and Nigeria, according to an announcement.

Rapid fire

Here are a few more vendor-related news items, in rapid fashion:

  • Consulting firm Frost & Sullivan recently recognized Hyperfine for creating the first “truly portable” MRI system.
  • Radiopharma firm RayzeBio just raised $45 million in Series A financing.
  • Bayer has launched a new campaign to increase education around dense breasts and supplemental screenings.
  • Meanwhile, Hologic this week announced a multi-year commitment to addressing breast cancer screening disparities among black women.
  • Standard & Poor’s has revised its outlook on nuclear medical imaging firm Curium Midco to negative following a recent debt-funded transaction.
  • Royal Philips has partnered with training provider LeQuest to boosting ultrasound education offerings.
  • Sectra just inked an enterprise imaging contract with eight National Health Service hospital trusts in Greater Manchester.
  • And finally, Varian announced this week that it has received an Investigational Device Exemption from the FDA for the first-ever clinical trial of FLASH therapy—an experimental treatment modality that delivers radiation therapy at ultra-high dose rates.
Marty Stempniak

Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic. 

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