Amber Implants Reports the US FDA’s 510(k) Clearance of VCFix Spinal System for Treating Vertebral Compression Fractures

Shots: The US FDA has granted 510(k) clearance to VCFix Spinal System for thetreatment of vertebral compression fractures The company plans to launch a US pilot program in early 2026, expand physician access later that year, extend the EXPAND trial into the US, & pursue EU label expansion for stand-alone use & one-level fixation integration…

ByRidhi RastogiSeptember 17, 2025

NEWS

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…

ByRidhi RastogiSeptember 17, 2025

NEWS

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 follow The Idylla CDx MSI Test helps identify MSI-H colorectal cancer pts eligible for Opdivo (nivolumab) alone or with Yervoy (ipilimumab), as…

ByRidhi RastogiSeptember 17, 2025

NEWS

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 2026 Womed Leaf was evaluated in the PREG2 trial (n=160) for mod. to sev. intrauterine adhesions, showing reduced severity of intrauterine adhesion after hysteroscopic…

ByRidhi RastogiSeptember 16, 2025

NEWS

Novocure Reports MHLW’s Approval of Optune Lua for NSCLC

Shots: Approval of Optune Lua for adults with unresectable advanced/recurrent NSCLC who progressed on Pt-based regimen, was based on P-III (LUNAR) trial assessing it with PD-1/PD-L1 inhibitors or docetaxel (n=145) vs PD-1/PD-L1 inhibitors or docetaxel alone (n=146) Trial showed an mOS (1EP) of 13.2 vs 9.9mos. in the overall population, 19 vs 10.8mos. with Optune Lua +…

ByRidhi RastogiSeptember 16, 2025

NEWS

AVITA Medical Secures European CE Mark Approval for Recell Go to Advance Burn and Wound Healing

Shots: AVITA Medical has received European MDR CE Mark approval for Recell Go to promote healing in burns & traumatic or surgical wounds; commercialization to begin in select EU states, incl. Germany, Italy, & the UK Recell Go is a point-of-care device that allows clinicians to create a suspension of a patient’s own skin cells from…

ByRidhi RastogiSeptember 15, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Sep 08, 2025 – Sep 12, 2025)  

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar, and DigiHealth. Check out our full report below:   AstraZeneca Reports P-III (FLAURA2) Trial Findings on Tagrisso Regimen to Treat EGFRm NSCLC Read More: AstraZeneca Eli Lilly Reports P-III (BRUIN CLL-313) Trial Data on Jaypirca for 1L…

ByRidhi RastogiSeptember 12, 2025

NEWS

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 analysis Tempus Pixel delivers advanced viewing & automated reporting of cardiac MR images, improving efficiency and accuracy in flow visualization, functional…

ByRidhi RastogiSeptember 12, 2025

NEWS

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 adolescents The 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…

ByRidhi RastogiSeptember 11, 2025

NEWS

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 & panels The 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…

ByRidhi RastogiSeptember 11, 2025

Amber Implants Reports the US FDA’s 510(k) Clearance of VCFix Spinal System for Treating Vertebral Compression Fractures

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

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

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

Novocure Reports MHLW’s Approval of Optune Lua for NSCLC

AVITA Medical Secures European CE Mark Approval for Recell Go to Advance Burn and Wound Healing

PharmaShots Weekly Snapshots (Sep 08, 2025 – Sep 12, 2025)

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

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

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

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