Smith+Nephew Reports Trial Data of Cartiheal Agili-C to Treat Knee Cartilage Defects

Shots: Smith+Nephew has reported data from its trial assessing Cartiheal Agili-C implant vs SoC for the treatment of knee cartilage defects Trial showed that the Cartiheal Agili-C significantly improved knee pain & quality of life over 4yrs., with an 87% reduced risk of total knee arthroplasty or osteotomy compared to SoC Pts also reported improved…

ByRidhi RastogiMay 8, 2025

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Roche Launches Elecsys PRO-C3 Test for Liver Fibrosis Severity Assessment

Shots: Roche has launched its Elecsys PRO-C3 test, developed with Nordic Bioscience to evaluate the severity of liver fibrosis in pts showing signs of metabolic dysfunction–associated steatotic liver disease Elecsys PRO-C3 test requires a single assay & in combination with ADAPT formula (incl. PRO-C3 levels, platelet count, age, & diabetes status) provides clear assessment of…

ByRidhi RastogiMay 6, 2025

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Endogenex Reports REGENT-1 Australian Clinical Study Data of ReCET System for Type 2 Diabetic Duodenopathy

Shots: Endogenex has reported REGENT-1 Australian study data of ReCET System for the treatment of inflamed & dysfunctional tissue associated with type 2 diabetic (T2D) duodenopathy; REGENT-1 is also being conducted in the US The study showed dose-responsive improvements in insulin sensitivity & beta cell function at 12wks., sustained through 48wks., with 100% procedural success…

ByRidhi RastogiMay 5, 2025

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OcuSciences’ OcuMet Beacon Receives the US FDA Clearance for Retinal Health Assessment

Shots: OcuSciences has received the US FDA clearance for OcuMet Beacon, a non-invasive confocal scanning ophthalmoscope designed for infrared & autofluorescence imaging of the human retina, with or without the use of a mydriatic agent Peer-reviewed clinical studies have showed favorable safety & clinical utility of the OcuMet Beacon, with dozen new studies presented at…

ByRidhi RastogiMay 2, 2025

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Teleflex’s QuikClot Control+ Hemostatic Device Receives the US FDA’s 510(k) Clearance to Temporary Control All Bleeding Grades

Shots: The US FDA has granted 510(k) clearance for label expansion of QuikClot Control+ Hemostatic Device to control all grades of internal & external bleeding Label expansion was supported by real-world evidence from an observational study evaluating QuikClot Control+ in 603 US emergency, trauma, & surgical pts across all bleeding grades & varied anatomical sites…

ByRidhi RastogiApril 30, 2025

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Personalis Reports Interim VICTORI Study Data of NeXT Personal Assay for the Detection of Colorectal Cancer (CRC)

Shots: Personalis has reported interim VICTORI study data assessing its NeXT Personal assay for the detection of early residual or recurrent CRC via ctDNA using blood samples from 71 pts with resectable Stage I-IV CRC At 15.75mos. mFU, 100% pts with recurrences, incl. distant metastases, were detected via ctDNA before imaging, with 87% detected within…

ByRidhi RastogiApril 29, 2025

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Kardium Reports Preliminary PULSAR IDE Trial Data of Globe PF System for Paroxysmal Atrial Fibrillation (PAF)

Shots: Kardium has reported 1yr. global PULSAR IDE trial data assessing Globe PF System in 183 symptomatic PAF pts across 12 centers in the US, EU, & Canada; Globe PF under the PMA review with the US FDA Trial showed 0% device-related safety events, 78% 12mos. effectiveness, 100% acute procedural success, 25min. average time to isolate…

ByRidhi RastogiApril 28, 2025

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CIRCA Scientific Reports the US FDA’s 510(k) Clearance of PeriCross Epicardial Access Kit for Controlled Pericardial Space Access

Shots: The US FDA has granted 510(k) clearance to PeriCross for controlled & efficient access to pericardial space through subxiphoid approach; US launch expected in coming mos., with select global expansion planned for 2026 Preliminary EASY-R trial data (enrolment completed) in 21 pts showed 100% access success, with mean access time of 3.5 ± 2.2min,…

ByRidhi RastogiApril 25, 2025

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Veravas Launches VeraBIND Tau to Detect Alzheimer’s Disease & other Tauopathies

Shots: Veravas has launched VeraBIND Tau to detect both symptomatic & pre-symptomatic pts with Alzheimer's disease (AD) or other tau-related neurodegenerative disorders (tauopathies) In an analytical verification study, VeraBIND Tau showed 96% sensitivity, 90% specificity, & 92% agreement with tau PET imaging, detecting Alzheimer’s-related tau & offering VeraBIND Tau score, a semi-quantitative measure of pathologically…

ByRidhi RastogiApril 23, 2025

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Exact Sciences launches Oncodetect for Molecular Residual Disease (MRD) Detection

Shots: Exact Sciences has launched Oncodetect to detect MRD across multiple solid tumors, with its efficacy supported by strong clinical validation, incl. ~5yrs. of follow-up data from the Alpha-CORRECT study Addiitonally, clinical & analytical validation studies across multiple solid tumors are underway, supported by strategic partnerships for multi-cancer evidence generation Oncodetect test provides clear “Detected”…

ByRidhi RastogiApril 22, 2025

Smith+Nephew Reports Trial Data of Cartiheal Agili-C to Treat Knee Cartilage Defects

Roche Launches Elecsys PRO-C3 Test for Liver Fibrosis Severity Assessment

Endogenex Reports REGENT-1 Australian Clinical Study Data of ReCET System for Type 2 Diabetic Duodenopathy

OcuSciences’ OcuMet Beacon Receives the US FDA Clearance for Retinal Health Assessment

Teleflex’s QuikClot Control+ Hemostatic Device Receives the US FDA’s 510(k) Clearance to Temporary Control All Bleeding Grades

Personalis Reports Interim VICTORI Study Data of NeXT Personal Assay for the Detection of Colorectal Cancer (CRC)

Kardium Reports Preliminary PULSAR IDE Trial Data of Globe PF System for Paroxysmal Atrial Fibrillation (PAF)

CIRCA Scientific Reports the US FDA’s 510(k) Clearance of PeriCross Epicardial Access Kit for Controlled Pericardial Space Access

Veravas Launches VeraBIND Tau to Detect Alzheimer’s Disease & other Tauopathies

Exact Sciences launches Oncodetect for Molecular Residual Disease (MRD) Detection

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