Abbott Laboratories announced a class I recall of the Heartmate 3 left ventricular assist system (LVAS) that affects nearly 890 units distributed over the past three years, a move triggered by reports of blood leakage or air entry into the device during implant procedures.

Nuvo Group Ltd. recently completed a business combination with Los Angeles Media Fund (LAMF) Global Ventures Corp, a special purpose acquisition company, and became a listed company in a bid to bring its Invu pregnancy monitoring and management platform to as many women as possible. “We are totally focused on women's health and trying to drive better outcomes through pregnancy care,” Rice Powell, CEO of Nuvo, told BioWorld.

News out of the Heart Rhythm Society 2024 meeting May 16-19 highlighted the rapid disruption pulsed field ablation (PFA) devices have wrought in cardiac arrhythmia treatment, so it is little surprise to see that PFAs are among the top five technologies with transformative potential identified by Clarivate plc in its Medical Technologies to Watch in 2024 report. The impact of the other four – continuous glucose monitors (CGM) for diabetes, neurostimulation devices, surgical robotics and renal denervation – has been just as revolutionary, if longer in being realized.

The U.S. Trade Representative (USTR) once again called out the usual cast of characters in this year’s Special 301 Report for not playing by the rules when it comes to protecting intellectual property. And once again, industry asked the USTR to go further by placing new players on the list.

The Cleveland Clinic Foundation (CCF) has found itself on the wrong end of an enforcement action by a federal attorney’s office, which had alleged that CCF had made false statements to the government regarding three grant awards.

A renewed focus on telehealth and telemedicine may be pumping new life into remote patient monitoring for heart failure, which seems to be the case for the Cardiomems device by Abbott Inc.

The major players in electrophysiology – Boston Scientific Corp., Johnson & Johnson, Medtronic plc, Abbot Laboratories – showed up in force at the 2024 Heart Rhythm Society annual meeting in Boston May 16-19 to tout their pulsed field ablation devices and study results.

U.S. Medicare coverage of transcatheter aortic valve replacement devices requires the use of team medicine for patient selection purposes, which seems to have served as a tripwire for Cape Cod Hospital (CCH) in Hyannis, Mass. Federal agencies forged an agreement with CCH that included a $24 million fine for failure to appropriately screen patients for the procedure, an event that serves as a reminder that non-compliance with Medicare rules can trigger enforcement actions by other agencies.

Pulsed field ablation dominated the news out of the Heart Rhythm Society meeting this week with three late-breaking studies highlighting the safety and efficacy of the technology replacing thermal ablation for treatment of atrial fibrillation and active discussion of the ‘unprecedented’ growth of these procedures. Boston Scientific Corp’s Farapulse is rapidly building dominance in the field, while results from Johnson & Johnson’s Varipulse study and Medtronic plc’s trial of the Affera system set up those companies for U.S. FDA approval later this year.

The U.S. FDA has several methods for signaling its enforcement intentions regarding medical devices and drugs, but there are times when warning letters are the vectors for communicating the agency’s current thinking.