Bendit Technologies has secured 510(k) clearance from the U.S. Food and Drug Administration for its Bendit17 steerable microcatheter, a device the company describes as the smallest steerable microcatheter available for use in neurovascular and peripheral endovascular interventions. With U.S. commercialization slated to begin in January 2026, the Israel-based medical device manufacturer is also pursuing regulatory
Subsense, Inc. has raised an additional $10 million in funding to accelerate the development of its non-surgical, nanoparticle-based brain-computer interface (BCI), bringing its total funding to $27 million. The financing, led by Golden Falcon Capital, follows early successes in nanoparticle design, in vitro signal stimulation, and the construction of a bio-integrated hardware-software platform intended to
Prelude Corporation has announced the first independent validation of AidaBreast, a multi-omic diagnostic test developed to predict both locoregional recurrence risk and individualized radiation therapy benefit in early-stage hormone receptor-positive, HER2-negative invasive breast cancer. The study, conducted at Royal Melbourne Hospital and presented at the San Antonio Breast Cancer Symposium 2025, evaluated over 400 women
Exact Sciences Corporation has presented first-time clinical results for its Oncodetect molecular residual disease (MRD) test in early triple-negative breast cancer (TNBC), showcasing a strong correlation between circulating tumor DNA (ctDNA) detection and recurrence risk following neoadjuvant therapy and surgery. The results, drawn from a 147-patient cohort in the NSABP B-59 substudy, were unveiled at
Gad Medical Ltd. has received regulatory clearance in Israel to commence commercial distribution of the RJB intraoperative angle measurement system from Ruthless Spine, a United States-based medical technology company. This milestone follows the companies’ earlier distribution agreement and paves the way for hospitals and surgical centers across Israel to integrate the RJB platform into thoracolumbar
Why this collaboration marks a turning point for AI-driven breast cancer diagnostics The ECOG-ACRIN Cancer Research Group and Caris Life Sciences have released early findings from a large-scale collaboration aimed at transforming how recurrence risk is predicted in early-stage breast cancer. Presented at the 2025 San Antonio Breast Cancer Symposium, the joint effort has produced
Nitinotes Ltd. has begun patient enrollment in its pivotal U.S. Investigational Device Exemption study evaluating the EndoZip Automated Suturing System for endoscopic sleeve gastroplasty (ESG). The first procedure in the EASE Clinical Trial was completed at Lenox Hill Hospital | Northwell Health in New York, marking the U.S. debut of the device. This study pits
ImpetusDX has introduced its IDX Oral Health Microbial Testing panel, a rapid saliva-based diagnostic tool that identifies key oral bacteria within 24 to 48 hours, offering a streamlined way to detect periodontal pathogens during routine hygiene visits. Developed by the oral diagnostics company and processed through the CAP-accredited and CLIA-certified lab infrastructure of Physicians Choice
Medical Manufacturing Technologies has been acquired by Perimeter Solutions for $685 million in a cash-backed deal, marking a strategic shift for the Clayton, Missouri-based specialty chemicals company toward the precision-driven medical manufacturing sector. The acquisition, announced by both parties in December 2025, is expected to close in the first quarter of 2026, subject to regulatory
MATELASER, INC. has launched the W1 REGEN Series, a wearable cold laser therapy device delivering 5,100 mW/cm² of dual-wavelength red and near-infrared light through a 24-gram unit, positioning it as the lightest high-power photobiomodulation device ever commercialized. The official debut, coupled with a Kickstarter campaign and a planned CES 2026 showcase, marks an aggressive bid