After Novosis Putty gained U.S. FDA breakthrough device designation of bio-fusion spine implantation device, South Korea’s Cgbio Co. Ltd. posted positive findings of similar ceramic bone graft, Novosis, to lay groundwork for U.S. market entry.

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.

Medtronic plc said its investigational Omniasecure defibrillation lead met its primary safety and effectiveness endpoints and exceeded prespecified performance goals, in the global Lead Evaluation for Defibrillation and Reliability (LEADR) pivotal trial.

Elixir Medical Corp. revealed that data from the Pinnacle I study has validated the safety and effectiveness of its Lithix Hertz contact intravascular lithotripsy system to treat moderate to severe calcified coronary artery lesions by percutaneous transluminal coronary angioplasty.

Data from the transcatheter valve and vessel trial showed that percutaneous interventions in patients with aortic stenosis and coronary disease resulted in significantly lower mortality rates than those receiving surgical treatment.

Field Medical Inc. kicked off its first-in-human study for its Fieldforce ablation system, designed for use in ventricular arrhythmias. The Ventricular Catheter Ablation Study study will enroll 60 patients in five centers around the world, most recently kicking off in the Na Homolce Hospital in Prague, Czech Republic.

Less than a week ago, executives at Lyra Therapeutics Inc. were looking ahead to “imminent” data from its first phase III study in chronic rhinosinusitis (CRS), testing drug-device candidate LYR-210, a drug-device candidate largely expected to fill a much-needed gap in CRS treatment. On Monday, May 6, they were announcing plans to preserve cash in the wake of the failed Enlighten 1 study, which raised doubts as to the feasibility of the company’s CRS programs, which also include the similarly designed candidate LYR-220.

Lindis Blood Care GmbH recently revealed excellent data from the Remove study that showed that its Catuvab device was safe and effective in removing tumor cells from intraoperative blood during high blood loss cancer surgeries.

Precision medicine holds exciting promise for the medical device industry as it offers a range of solutions within diagnostics, digital devices and imaging, which could transform patient care, delegates heard at the LSX World Congress in London. However, there are a range of challenges ahead, including the population of clinical data, getting past the inertia of physicians and making it easier to run clinical studies.

Acrivon Therapeutics Inc.’s $130 million financing disclosed April 9 hiked confidence in then-pending data with ACR-368 (prexasertib), the selective small-molecule inhibitor that targets checkpoint kinase 1 (CHK1) and CHK2. Undergoing tests in a potentially registrational phase II trial across multiple tumor types, ACR-368 also raised the stakes for Boundless Bio Inc., which is developing CHK1 inhibitor BBI-355.