Smart Meter Launches iAmbientHealth for Remote Patient Monitoring

Shots: Smart Meter has launched iAmbientHealth to passively track heart rate, respiration, movement & bed exits without wearables or cameras iAmbientHealth provides continuous real-time health insights & predicts health events up to 7 days in advance, where in a study with 200 pts, it predicted over 75% of hospital transfers & reduced hospitalizations by 50%…

ByRidhi Rastogi18 hours ago

NEWS

Medtronic’s Altaviva Device Receives the US FDA’s Approval to Treat Urge Urinary Incontinence

Shots: The US FDA has approved the Altaviva device, an implantable tibial neuromodulation therapy to treat urge urinary incontinence Altaviva device is placed under the skin above the fascia & near the ankle in a minimally invasive, sedation & imaging-free procedure to restore bladder–brain communication & improve bladder control by delivering electrical impulses to the tibial…

ByRidhi Rastogi4 days ago

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Sep 15, 2025 – Sep 19, 2025)  

PharmaShots Weekly Snapshots (Sep 15, 2025 – Sep 19, 2025)   This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, COVID-19, M&A and Biosimilars. Check out our full report below:   MAIA Biotechnology Reports P-II (THIO-101) Trial Data of Ateganosine Regimen for Advanced NSCLC Read More: MAIA Biotechnology Akeso Reports First…

ByRidhi RastogiSeptember 19, 2025

NEWS

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

Smart Meter Launches iAmbientHealth for Remote Patient Monitoring

Medtronic’s Altaviva Device Receives the US FDA’s Approval to Treat Urge Urinary Incontinence

PharmaShots Weekly Snapshots (Sep 15, 2025 – Sep 19, 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)

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