Medical device news covering implants, diagnostics, recalls, FDA clearances, and medtech company performance.
Nyxoah reported its U.S. study for a sleep apnea device met all primary safety and efficacy endpoints in patients with complete concentric collapse of the soft palate. The company achieved a 77% response rate with zero serious adverse events and plans to submit an FDA premarket approval supplement.
The FDA's TEMPO pilot program has accepted four generative AI medical devices, including products from Cadence and Limbic, for provisional market access. This initiative aims to increase technology availability for the Medicare ACCESS model, which funds chronic condition management tools, while the agency continues developing broader regulatory frameworks for AI-driven care.
Globus Medical received CE mark approval for its Excelsius3D imaging system, enabling commercial sales across the EU and UK. The mobile platform integrates 3D CT, 2D fluoroscopy, and digital radiography with robotic navigation for surgical use. The device was previously cleared by the FDA in 2021.
This commentary contends that attributing improved outcomes in total knee replacement solely to robotic assistance is an oversimplification. It argues that alignment strategy selection and patient heterogeneity are critical variables, suggesting that surgeon preference and anatomical tailoring play equally significant roles in surgical success.
This analysis examines Insulet's Q2 earnings within the broader patient monitoring sector, noting industry growth driven by chronic disease prevalence and digital health adoption. It suggests that while revenues beat estimates, upcoming guidance misses and regulatory challenges present headwinds for companies like Insulet in the US healthcare market.
The article contends that while dental technology stocks like Align Technology reported strong Q2 revenues, sector headwinds including economic uncertainty and pricing pressures from consolidated dental service organizations may impact future performance. It suggests that despite beating estimates, share price declines reflect broader market concerns about discretionary spending.
InnovHeart successfully implanted its Saturn Transseptal Transcatheter Mitral Valve Replacement System in an 86-year-old female at NewYork-Presbyterian/Columbia University Irving Medical Center. The procedure, performed by Dr. Torsten P. Vahl, marks the first U.S. case in the CASSINI-US Early Feasibility Study, bringing the global total of treated patients to 15.
Bloomberg Intelligence reports that FocalTherics is developing a unified platform combining high-intensity focused ultrasound and histotripsy. The company argues this technology offers non-invasive treatment options for prostate cancer, benign prostatic hyperplasia, and endometriosis.
The FDA cleared software enhancements for Modular Medical's Pivot insulin delivery system, adding expanded bolus dosing customization and an improved user interface. CEO Jeb Besser confirmed the approval arrives ahead of the planned fourth-quarter commercial launch with partner Inizio. Shares rose nearly 7% in premarket trading on Thursday.
ONWARD Medical performed the first implantation of its ARC-IM System during the EIGER clinical feasibility study on Thursday. The trial, conducted at two Swiss medical centers, aims to evaluate the safety and effectiveness of restoring mobility in patients with subacute or chronic spinal cord injuries.