Shots:
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…
Shots:
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)…
Shots:
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…
Shots:
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…
Shots:
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…
Shots:
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…
Shots:
Caris has launched Caris MI Clarity, an AI-driven prognostic test for postmenopausal pts with HR+/HER2-, node-negative early-stage breast cancer, designed to assess both early (0–5yrs.) & late (5–15yrs.) distant recurrence risk from a single test at diagnosis
The test leverages Caris’ multimodal dataset, computational pathology & AI-driven ML to analyze digitized H&E slides and…
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Multi4 Medical received CE mark approval for the Multi4 System, an all-in-one bladder cancer treatment platform enabling treatment during the same outpatient visit without operating room use, anesthesia, or hospitalization
The Multi4 instrument integrates local anesthesia delivery, tumor resection, automatic tissue extraction for pathology, & cauterization into a single endoscopic device, allowing awake pts…
Shots:
Ortho Development has reported the full US commercial launch of the Trivicta Hip Stem, a cementless triple-taper femoral component for primary total hip arthroplasty, following a controlled market introduction
Trivicta system features a 35μm hydroxyapatite coating over sintered titanium beads to support early osteointegration, alongside standard & extended offset options, progressive neck lengths, &…

