Edwards Lifesciences Wins FDA Approval for AUTUS Pediatric Pulmonary Valve

Smith+Nephew has announced that its CARTIHEAL AGILI-C cartilage repair implant is now commercially available in Europe, following its U.S. introduction in 2024. The implant, made of aragonite, a natural form of calcium carbonate that acts as a biphasic scaffold, is designed to repair cartilage, restore bone and relieve pain, and will be featured at the International Cartilage Regeneration & Joint Preservation Society Congress in Porto, Portugal, from October 8 to 10. A multicenter randomized clinical trial published in the American Journal of Sports Medicine found that the CARTIHEAL AGILI-C implant achieved superior overall KOOS scores compared with standard surgical treatment at all time points evaluated through 60 months of follow-up, with greater pain relief and functional improvement at 2, 4 and 5 years and no statistically significant difference in clinical outcomes between patients with and without osteoarthritis. Joaquín Lasso, Senior Vice President and International General Manager of Sports Medicine at Smith+Nephew, said the European launch offers surgeons an innovative, evidence-backed solution for cartilage repair. The implant will launch initially in Austria, Belgium, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Switzerland and the United Kingdom, with expansion to other countries expected shortly after.

Tempus AI has received 510(k) clearance from the Food and Drug Administration for two next-generation AI cardiovascular products, Tempus ECG-MR and Tempus ECG-PH. Tempus ECG-MR analyzes standard 12-lead resting electrocardiograms to detect signs associated with undiagnosed moderate or severe mitral regurgitation, while Tempus ECG-PH is an AI-enabled software device that analyzes standard 12-lead ECG data and provides a binary output for signs associated with pulmonary hypertension. The clearances come as the AI-ECG analysis market is expected to grow from $2.01 billion in 2025 to $2.40 billion in 2026, a compound annual growth rate of 19.3%, according to the Business Research report. Among peers, GE HealthCare's Advanced Imaging Solutions segment, which combines the former Imaging and AVS businesses, generated $3.77 billion in revenues in the second quarter of 2026, up 5.0% organically, with segment EBIT margin rising 90 basis points to 13.9%. iRhythm Holdings, whose platform is supported by more than 3 billion hours of curated ECG data and more than 12 million patient reports, expanded work with Desert Oasis Healthcare and signed two commercial agreements through Luum during the second quarter of 2026. Tempus shares have declined 17.7% over the past year, and the stock currently trades at a forward 12-month price-to-sales ratio of 7.30X versus an industry average of 4.82X.

Abbott announced U.S. Food and Drug Administration approval for updates to its CardioMEMS HF System that, for the first time, let U.S. CardioMEMS patients view their pulmonary artery pressure readings directly on their smartphones through the new CardioGuide HF App. The new capabilities also include Dynamic Treatment Plan, a software feature that lets clinicians set up personalized medication adjustment plans based on changes in a patient's pulmonary artery pressure and send medication adjustment instructions directly to patients through the app. The CardioMEMS HF System, which measures pulmonary artery pressure through an implanted sensor in the pulmonary artery, has been shown to reduce heart failure hospitalizations and mortality risk, and clinicians have used its readings for more than a decade to identify signs of worsening heart failure and guide treatment. Abbott said it plans to make the CardioGuide HF App and Dynamic Treatment Plan available later this year. Katie Spayde, vice president of Abbott's heart failure division, said the new capabilities help patients stay informed, engaged and connected to their care between doctor visits.

AtriCure's fair value price target has shifted from about US$51.67 to about US$54.89, reflecting modest fine tuning in analyst models rather than a wholesale reset. BTIG raised its AtriCure price target to US$55 from US$45, pointing to the new STS Quality Metric, which it thinks could support greater use of the EnCompass Clamp in U.S. surgery patients with preoperative atrial fibrillation, and noting that only about 35% of atrial fibrillation patients undergoing cardiac surgery in the U.S. currently receive a surgical ablation. BTIG models potential upside to AtriCure's U.S. Open Ablation revenue of US$10m to US$25m in 2027 and US$20m to US$55m in 2028 compared with its prior forecasts. UBS keeps a Buy rating on AtriCure alongside a revised price target of US$50 from US$55, citing business growth excluding MIS as support for what it describes as sustainable double digit top line expansion. Freedom Capital downgraded AtriCure to Hold from Buy and lifted its target to US$57 from US$43, expecting BoX-NoAF POAF data in Q2 2027 to be positive but flagging that earlier supportive data carries caveats, which it thinks reduces the margin for error if results or execution fall short of expectations. Revenue growth assumptions are broadly steady, moving from about 12.33% to about 12.35%, net profit margin expectations remain around 4.55%, future P/E has moved from about 94.5x to about 101.3x, and the discount rate is broadly unchanged, moving from about 7.52% to about 7.55%.