Abbott Wins FDA Approval for CardioMEMS HF System Patient-Facing Updates

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.

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%.

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.

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.

Orchestra BioMed Holdings has surpassed full enrollment in the BACKBEAT Global Pivotal Trial of AVIM Therapy, with 330 patients randomized as of September 30, 2026, exceeding the previously announced target of 316. The trial is evaluating Atrioventricular Interval Modulation Therapy in pacemaker-indicated patients with uncontrolled hypertension despite medication, and is being conducted with Medtronic, the company's strategic collaborator for the trial and, subject to regulatory approval, for commercialization of AVIM Therapy. Enrollment reached 330 patients at 81 sites across 13 countries, while the FDA-approved protocol specifies 284 evaluable randomized subjects for the primary endpoint analysis, with the 316-patient target accounting for potential loss to follow-up. Orchestra BioMed reiterated prior guidance that primary endpoint data will be submitted for late-breaking presentation consideration at a major cardiovascular conference in the second quarter of 2027, and assuming positive results, Medtronic plans to submit AVIM Therapy marketing applications to the FDA and other global regulatory agencies promptly. The trial's primary efficacy endpoint is the between-group difference in the change in 24-hour ambulatory systolic blood pressure at three-month follow-up from pre-randomization baseline, and the protocol-specified sample size provides greater than 90% statistical power to detect a between-group difference of at least 5 mmHg.