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

NEWS

Exact Sciences Launches Cancerguard Test for Early Multi-Cancer Detection

Shots: Exact Sciences has introduced the Cancerguard test for early multi-cancer detection & has partnered with Quest Diagnostics to expand patient access in the US Cancerguard is supported by extensive clinical data, incl. DETECT-A & ASCEND 2 studies in over 20,000 subjects. Additionally, Exact is enrolling ~25,000 participants in the Falcon registry study following the…

ByRidhi RastogiSeptember 10, 2025

NEWS

Varian’s Embozene Receives the European CE Mark Approval for Use in Genicular Artery Embolisation to Treat Knee Osteoarthritis

Shots: Varian has reported the European CE Mark approval of Embozene microspheres for genicular artery embolisation (GAE) to treat knee osteoarthritis Additionally, a Varian-sponsored GENESIS II trial, assessing GAE vs sham treatment for knee osteoarthritis, has completed patient enrollment in the UK GAE aims to reduce knee pain by advancing a small catheter into the…

ByRidhi RastogiSeptember 9, 2025

NEWS

Pulse Biosciences Receives FDA IDE Approval for nsPFA Cardiac Surgery System to Treat Atrial Fibrillation

Shots: Pulse Biosciences has received the US FDA IDE approval to initiate its NANOCLAMP AF study evaluating nsPFA system in ~136 pts with atrial fibrillation (AF) across 20 sites, incl. 2 outside the US The EU feasibility study of nsPFA Cardiac Clamp began in Aug 2024 with over 40 pts across 3 sites The Netherlands,…

ByRidhi RastogiSeptember 9, 2025

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

Exact Sciences Launches Cancerguard Test for Early Multi-Cancer Detection

Varian’s Embozene Receives the European CE Mark Approval for Use in Genicular Artery Embolisation to Treat Knee Osteoarthritis

Pulse Biosciences Receives FDA IDE Approval for nsPFA Cardiac Surgery System to Treat Atrial Fibrillation

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