Shots:
Tempus AI has reported clinical launch of the ArteraAI Prostate Test (mHSPC), a CLIA-certified & CAP-accredited prognostic assay designed for pts with metastatic hormone-sensitive prostate cancer (mHSPC)
ArteraAI Prostate Test (mHSPC) is an externally developed digital pathology algorithm clinically available through the Tempus AI ecosystem, with full platform integration to support personalized treatment decisions…
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Reflow Medical has reported the DEEPER CORONARY study results evaluating the short-term safety of the coronary Spur Elute Sirolimus-Eluting Retrievable Stent System for coronary ISR at EuroPCR 2026
6mos. results showed 100% freedom from MACE & all-cause mortality in nine treated pts, while all patients demonstrated improved CCS angina class with a median improvement of…
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Sensome has reported results from its INSPECT study assessing its microsensor technology integrated into a smart stylet for bronchoscopic lung biopsy in 27 pts across Australia & France
In the study, the smart stylet was inserted into the biopsy needle to capture tissue readings immediately before biopsy, with histopathology confirming measurement accuracy & cross-validating…
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The US FDA has granted clearance to Sunrise Air, an at-home sleep apnea diagnostic platform designed to expand access to sleep care through a fully home-based testing solution, following a $29M funding round
The lightweight, rechargeable device is built around the company’s mandibular jaw movement (MJM) tech, which captures chin movement signals & uses…
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The 2 studies evaluated IPDE therapy for lower urinary tract symptoms (LUTS) secondary to BPH, assessing delivery of paclitaxel-eluting bioabsorbable implants through transperineal & transrectal approaches
In the transperineal study (n=20), IPDE improved IPSS by 15 points & Qmax by ~4 mL/s at 1yr., achieving benefit in 80% pts, while the transrectal study (n=11)…
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Revvity has received the US FDA clearance for its Total Testosterone automated chemiluminescence immunoassay (ChLIA), expanding its endocrine diagnostics portfolio
The portfolio enables direct ChLIA measurement of total testosterone, SHBG, & free testosterone, supporting both first & second-line diagnostic testing for suspected male hypogonadism
Processed on IDS’ random-access automation platforms, the expanded portfolio enables…
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Cepheid has received IVDR CE marking for the Xpert GI Panel, a multiplex PCR assay designed to detect 11 clinically relevant GI pathogens from a single stool sample using the 10-color multiplexing technology on GeneXpert Systems
The assay simultaneously identifies bacterial, viral, & parasitic pathogens directly from stool specimens in Cary-Blair transport media, requiring…
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Exero Medical has reported clinical trial data assessing xBar monitoring system to detect post-operative anastomotic leaks in colorectal resection surgery pts (n=222)
Study showed that the xBar system detected post-operative anastomotic leaks in colorectal resection pts earlier than standard clinical practice, achieving 100% sensitivity & 88% specificity by post-operative day 3 & identifying leaks…
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Roche has received CE Mark for Elecsys pTau217 to measure the phosphorylated Tau (pTau) 217 protein to help rule in or rule out Alzheimer’s-related amyloid pathology
CE Mark was backed by retrospective real-world studies in early-stage Alzheimer’s pts, incl. Subjective Cognitive Decline, Mild Cognitive Impairment, & Mild Dementia, where individuals experience memory changes but…
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Bausch + Lomb has launched Bi-Blade+ advanced dual-port vitrectomy cutter on the Stellaris Elite Vision Enhancement System in the EU for anterior & posterior segment procedures requiring vitreous removal
Bi-Blade+ delivers a 25% higher flow rate for more efficient vitreous removal compared to Bi-Blade & demonstrated a 62% reduction in cutter vibration, aimed at…

