Exact Sciences unveils key Oncodetect results in TNBC: Is this a reimbursement turning point?

Exact Sciences unveils key Oncodetect results in TNBC: Is this a reimbursement turning point?

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 […]

Ruthless Spine’s RJB device approved in Israel, expanding navigation tech reach

Ruthless Spine’s RJB device approved in Israel, expanding navigation tech reach

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 […]

New AI model from Caris and ECOG-ACRIN predicts breast cancer relapse up to 15 years

New AI model from Caris and ECOG-ACRIN predicts breast cancer relapse up to 15 years

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 […]

What Nitinotes’ EASE trial tells us about the future of bariatric endoscopy

What Nitinotes’ EASE trial tells us about the future of bariatric endoscopy

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 launches rapid oral microbial test to bring real-time diagnostics to dental care

ImpetusDX launches rapid oral microbial test to bring real-time diagnostics to dental care

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 […]

Why Perimeter’s $685m move on MMT could reshape the medtech supply chain

Why Perimeter’s $685m move on MMT could reshape the medtech supply chain

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 […]

Could MATELASER’s VCSEL-based laser shift clinical recovery into self-care?

Could MATELASER’s VCSEL-based laser shift clinical recovery into self-care?

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 […]

Can Vesalio’s enVast reshape coronary thrombectomy with stent-based retrieval?

Can Vesalio’s enVast reshape coronary thrombectomy with stent-based retrieval?

Vesalio has received 510(k) clearance from the U.S. Food and Drug Administration for enVast, its stent-based coronary clot retrieval system, making it the first device of its kind approved for mechanical thrombectomy in the cardiac circulation. The approval authorizes enVast for U.S. commercialization, following prior regulatory clearance and use in European markets. The device is […]

Inside Xtant Medical’s Strata launch: What sets it apart from legacy bone grafts

Inside Xtant Medical’s Strata launch: What sets it apart from legacy bone grafts

Xtant Medical Holdings, Inc. has launched its next-generation synthetic bone graft, nanOss Strata, in the United States. The graft, built from hydroxycarbonapatite (HCA), is designed to enhance bioactivity and integration in orthopedic and spinal surgeries. This launch follows the company’s strategic exit from non-core spinal implant assets, signaling a renewed focus on its biologics portfolio. […]

Can Geneva PE’s NXXIM platform fix fragmentation in diagnostic imaging?

Can Geneva PE’s NXXIM platform fix fragmentation in diagnostic imaging?

Geneva Private Equity has launched NXXIM, a new AI-powered enterprise medical imaging platform designed to unify radiology, pathology, genomics, and electronic health record data into a single, real-time diagnostic environment. The investment-backed venture will pilot its platform in clinical settings in 2026, aiming to streamline fragmented workflows and reduce time-to-diagnosis for large health systems. What […]