Shockwave Medical Inc. is confident that its intravascular lithotripsy (IVL) system can continue to dominate the market for calcium modification even as other technologies emerge, chief medical officer Nick West told BioWorld.
Rebrain SAS's Optimmri platform received European Medical Device Regulation CE mark certification to enable surgeons to identify areas of interest in the brain during deep brain stimulation procedures for Parkinson's disease and essential tremor.
The long-term status of the trade dispute with China remains unclear, but a 90-day reduction in stratospheric tariffs imposed by the U.S. and China on their respective products provides breathing room for the med-tech companies predicting the hardest hit from the original levels.
With strong one-year results from the PULSAR trial, Kardium Inc. could soon be jockeying for third place in the race for pulsed field ablation market share. Boston Scientific Corp. clearly won the roses, with Medtronic plc solidly positioned to place, but the show spot – previously called as a battle between Johnson & Johnson and Abbott Laboratories – could go to this Canadian dark horse.
Pulsed field ablation dominated discussions and scientific sessions at Heart Rhythm 2025 in San Diego with researchers and manufacturers touting new applications in persistent atrial fibrillation, atrial flutter and addressing specific challenges for existing systems.
First quarter earnings reports from Edwards Lifesciences Corp., Intuitive Surgical Inc. and Boston Scientific Corp. support trends seen earlier: Larger med-tech companies expect substantial tariff hits, but also have confidence that they can absorb the impact with fairly minor adjustments.
Growth in the first quarter for Boston Scientific Corp.’s blockbuster products, Farapulse and Watchman, pushed the company well over analysts’ expectations and gave management confidence to raise its guidance for the year to 15% to 17% up from 12.4% to 14.5%, despite a projected $200 million in tariff impacts.
The American Medical Association’s CPT editorial panel will meet May 1-3 to consider codes for several devices and services, but the most important of these might be the code for cardiac contractility modulation.
Receipt of EU MDR CE mark may not be a magic potion, but Elixir Medical Corp. is certainly feeling a boost from the regulatory nod for its mechanical Lithix hertz contact intravascular lithotripsy system for treatment of moderate to severely calcified coronary artery lesions. Simultaneously, the company reported the launch of Lithix and completion of first cases in Italy, France and Germany.
The new technology add-on payment for the TAG thoracic branch endoprosthesis is likely coming to an end, but the device’s manufacturer, Gore Medical Inc., petitioned CMS to reassign the procedure to a new diagnostic-related group that would more accurately reflect the costs of the related procedure.
