Smith+Nephew has launched the EVOS PELVIC Plating System, the newest addition to its EVOS plating platform, designed for pelvic and acetabular fracture management. The all-in-one system combines pre-contoured plates for the posterior wall, quadrilateral surface and pubic symphysis, locking and non-locking utility plates, a new cannulated screw system built specifically for the pelvis and acetabulum, and specialized instrumentation to support exposure, fracture reduction and implant placement. Nate Folkert, President of Smith+Nephew Orthopaedics, called the launch an important milestone in the continued expansion of the EVOS Plate portfolio, while John Rawlinson, Senior Director of Global Marketing, said the brand reflects the company's mission to drive the Evolution of Osteosynthesis. Design surgeon Dr. Reza Firoozabadi of the University of Washington and Harborview Medical Center said the system was built to address the full spectrum of injuries, from straightforward to the most complex pelvic ring and acetabular fractures, including elderly patients with compromised bone quality. The EVOS PELVIC System is currently available in the United States, with availability and launch timing in other markets varying, and will be previewed at Smith+Nephew's booth #301 during the 2026 Orthopaedic Trauma Association Annual Meeting in Nashville, Tennessee from September 23 to 26.
Tempus AI Wins FDA Clearance for Two AI-ECG Cardiac Products
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 Wins FDA Approval for CardioMEMS HF System Patient-Facing Updates
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.
Aging Population › Medical Devices for the Aging Body ▲Technology
ABT · Technology · Positive FDA approval of CardioGuide HF App and Dynamic Treatment Plan updates to Abbott's CardioMEMS HF System, a new product/tech development.
AtriCure Fair Value Target Rises to US$54.89 as Analysts Split on Procedure Growth
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%.
Aging Population › Medical Devices for the Aging Body ▲Demand
ATRC · Capital · Positive Analyst fair-value target rises to ~US$54.89 with BTIG lifting its PT to US$55 on the new STS Quality Metric supporting EnCompass Clamp use.
Medtronic Raises Fiscal 2027 Guidance as Revenue Jumps 13.7%
Medtronic reported first-quarter fiscal 2027 revenue of $9.76 billion, up 13.7% from a year earlier, and raised its full-year outlook, with adjusted diluted EPS climbing 15.1% to $1.45 and GAAP EPS rising 40.7% to $1.14. Management now expects organic revenue growth of 7.25%-7.75% for fiscal 2027, up from 6.75%-7.25% previously, and lifted adjusted EPS guidance to $5.94-$6.00. The quarter included an extra selling week that added about $570 million to revenue, so the headline growth rate should not be expected to repeat. Cardiovascular delivered strong growth, while Neuroscience, Medical Surgical and Diabetes also posted high-single-digit or double-digit organic growth. At a share price of around $89-$90, the stock trades at roughly 15 times the midpoint of the adjusted EPS forecast, versus about 22 times trailing earnings, while paying a quarterly dividend of $0.72 per share, or $2.88 a year, for a yield of roughly 3.2%-3.3%. Medtronic is also expanding its Affera cardiac mapping and ablation system, investing in Pi-Cardia and Cornerstone Robotics, and has acquired Scientia Vascular and SPR Therapeutics, with a planned separation of its Diabetes business.
Edwards Lifesciences Wins FDA Approval for AUTUS Pediatric Pulmonary Valve
The US FDA has approved Edwards Lifesciences' AUTUS surgical pulmonary valve for pediatric patients with congenital heart disease. AUTUS is the first such pulmonary valve approved for children that can be expanded as a child grows, with the expansion performed through a transcatheter procedure. The approval was based on a study that found no patients had device-related complications after 30 days and no AUTUS valve reinterventions through six months. In patients with one-year follow-up, all showed consistent outcomes, with a right ventricular outflow tract mean gradient of 40 mmHg or less, less than moderate pulmonary regurgitation, and no valve reinterventions.
Aging Population › Medical Devices for the Aging Body Regulation
EW · Regulation · Positive FDA approval of the AUTUS pediatric pulmonary valve expands Edwards' transcatheter valve portfolio into a new pediatric indication.
Medtronic Wins Category I CPT Codes for Altaviva and Symplicity Spyral
Medtronic announced that the American Medical Association has approved new Category I Current Procedural Terminology codes for two of its technologies, the Altaviva implantable tibial neuromodulation device for urge urinary incontinence and the Symplicity Spyral renal denervation system for uncontrolled hypertension. The new codes, which replace existing Category III codes, take effect in January 2028. Category I codes are permanent codes assigned to procedures the AMA deems well established, widely performed across the United States, and supported by robust clinical evidence, and while they can help support physician payment and inform commercial payer coverage decisions, they do not determine coverage, reimbursement, clinical superiority, or patient access. The Altaviva device was approved by the U.S. Food and Drug Administration in September 2025 for urge urinary incontinence, a condition affecting 16 million adults in the United States, and is placed under the skin near the ankle in a minimally invasive procedure. The Symplicity Spyral system was finalized for Medicare coverage in October 2025, and Medtronic said its SPYRAL HTN global clinical program is the most comprehensive studying renal denervation, with more than 5,000 patients and experience in over 40,000 patients globally.
MDT · Regulation · Positive AMA approved permanent Category I CPT codes for Medtronic's Altaviva and Symplicity Spyral devices, supporting physician payment and payer coverage.