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Johnson & Johnson MedTech Launches Shockwave Javelin Peripheral IVL Catheter in the EU

Shots:J&J has launched Shockwave Javelin peripheral IVL catheter in the EU to modify calcium & cross extremely narrowed vessels in pts with peripheral artery disease (PAD)Shockwave Javelin was studied in FORWARD PAD IDE trial that demonstrated similar safety & effectiveness compared to balloon-based Shockwave IVL catheters, regardless of the nature of calcified lesions…
September 17, 2025

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Biocartis Reports the US FDA’s Approval of Idylla CDx MSI Test to Identify MSI-H Colorectal Cancer Patients

Shots:The US FDA has approved the PMA application for Idylla CDx MSI Test, a cartridge-based, fully automated “sample-to-result” companion diagnostic, with US launch anticipated soon & availability in other non-US markets to followThe Idylla CDx MSI Test helps identify MSI-H colorectal cancer pts eligible for Opdivo (nivolumab) alone or with Yervoy (ipilimumab), as…
September 17, 2025

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Womed Reports the US FDA’s Approval of Womed Leaf to Treat Asherman Syndrome

Shots:The US FDA has approved the PMA application of Womed Leaf for women undergoing hysteroscopic surgery for symptomatic moderate to severe intrauterine adhesions (Asherman syndrome); commercial launch expected in early 2026Womed Leaf was evaluated in the PREG2 trial (n=160) for mod. to sev. intrauterine adhesions, showing reduced severity of intrauterine adhesion after hysteroscopic…
September 16, 2025

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Tempus AI Receives the US FDA’s 510(k) Clearance for Updated Tempus Pixel Cardiac Imaging Platform

Shots:Tempus AI has received the US FDA 510(k) clearance for its updated Tempus Pixel, an AI-powered cardiac imaging platform, with the ability to generate T1 & T2 inline maps for enhanced cardiac MRI analysisTempus Pixel delivers advanced viewing & automated reporting of cardiac MR images, improving efficiency and accuracy in flow visualization, functional…
September 12, 2025

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neurocare Receives the US FDA’s Clearance for Apollo TMS Therapy Devices to Treat Major Depressive Disorder in Adolescents

Shots:neurocare has received US FDA clearance for its Apollo Transcranial Magnetic Stimulation (TMS) Therapy devices to treat major depressive disorder (MDD) in adolescentsThe Apollo TMS Therapy system is a non-invasive treatment that uses a magnetic coil on the head to stimulate targeted brain pathways, with about 60% of patients achieving remission with TMS…
September 11, 2025

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QIAGEN Secures CE-IVDR Certification for QIAstat-Dx Meningitis/Encephalitis Panel to Detect CNS Infections

Shots:QIAGEN has obtained European CE-IVDR certification for its QIAstat-Dx Meningitis/Encephalitis (ME) Panel to diagnose CNS infections, securing CE-IVDR approval for its entire QIAstat-Dx syndromic testing systems & panelsThe QIAstat-Dx ME Panel offers CNS infection coverage with 16 clinically relevant targets, incl. cytomegalovirus to meet current clinical needs & exclusive Streptococcus pyogenes detection to…
September 11, 2025

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