Imaging manufacturer Merit Medical Systems has reached an agreement that has it paying $18 million to settle a federal investigation, the company announced Wednesday.
The Department of Justice recently joined a whistleblower’s lawsuit, accusing the Utah-based firm of paying kickbacks to entice docs to use its interventional radiology products. Merit has agreed to settle the False Claims Act inquiry rather than fighting it in court but is not admitting any wrongdoing.
“Given the mounting costs and time demands associated with the investigation, we believe this resolution is in the best interests of the business,” Chairman and CEO Fred Lampropoulos said in a statement.
Former employee Charles Wolf, MD, first surfaced the allegations and stands to collect a share of the payout. He alleged that Merit provided paid advertising and consulting fees to docs in exchange for using the company’s products.
Founded in 1987, Merit dubs itself as a “leading” manufacturer and marketer of disposable devices used in interventional and diagnostic radiology, along with other specialties.
Insightec scores Medicare coverage for MR-guided tremor treatment
Medical tech company Insightec said Monday that it has achieved Medicare coverage for its MR-guided, focused-ultrasound treatment for essential tremor.
The Miami-based firm said CMS will now cover the procedure in all 50 states. In addition, 22 Independent Blue Cross Blue Shield Association plans are also reimbursing for the benefit.
"Complete Medicare coverage is a significant milestone for Insightec and brings the incisionless treatment option to millions of people," Chairman and CEO Maurice Ferré MD, said in in a statement. "This is the critical next step in our mission to make focused ultrasound a standard of care to improve the lives of people living with a challenging condition."
The company noted that “compelling clinical evidence” helped it secure coverage in the final two jurisdictions. The U.S. Food and Drug Administration first approved Insightec’s treatment for medication-refractor essential tumor back in 2016.
Xact Robotics scores FDA clearance
Massachusetts-based Xact Robotics has earned clearance from the U.S. FDA to market its system that assists docs with CT-guided percutaneous procedures.
Its new ACE Robotic System is the second-generation version of the product and is set to launch later this year. The firm said it initially plans to focus marketing efforts toward interventional radiologists, according to a July 15 announcement.
Xact claims it is the first and only company to market a hands-free robotic solution that combines imaging with insertion and steering of various instruments. The firm said its latest system can treat a wide range of clinical indications and is compatible with several imaging modalities.
Rad Partners adds COVID update to AI tool
California-based imaging giant Radiology Partners has added a new COVID-focused update to its RecoMD artificial intelligence tool.
The software uses natural language processing to help interpret physicians’ reports, offering up best practice recommendations in real time. With the new guidelines, RecoMD is now helping rads to characterize and report imaging findings related to the novel coronavirus. The system makes use of guidelines endorsed by RSNA and the American College of Radiology, company officials noted.
Rad Partners said using the AI tool has helped its member practices to improve clinical guideline adherence by upward of 83%.
Open Source Imaging Consortium launches $55K AI competition
The Open Source Imaging Consortium is launching a new AI competition in conjunction with data company Kaggle, the two announced earlier this month.
They’re offering up some $55,000, seeking a solution to predict lung function decline in individuals living with pulmonary fibrosis. OSIC is a global nonprofit aimed at bringing radiologists together with other clinicians and computational scientists to improve lung disease treatment.
Idiopathic pulmonary fibrosis, the group noted, has no known cure and appears on CT scans as scarring of the lungs that leads to an irreversible decline in breathing function. Those in the challenge will receive computed tomography scans from IPF patients and be tasked with devising machine learning methods to predict severity of this decline.
The competition is set to run through Oct. 6.