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NEWS

Neurogen Partners with Linus Health to Develop Early Detection Technology for Mild Cognitive Impairment and Dementia due to Alzheimer’s Disease

Shots: Neurogen Biomarking partnered with Linus Health to form a unified platform by incorporating the latter’s digital cognitive assessments with the Neurogen Biomarking ecosystem, commercially available in Q1’25 The new platform will integrate early detection & care for patients with MCI or dementia related to AD with Linus Health’s scientifically validated assessments to identify…
January 15, 2025

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NEWS

The US FDA grants 510(k) Clearance to Werfen’s Aptiva Antiphospholipid Syndrome (APS) Reagents

Shots: The US FDA has granted 510(k) Clearance for Aptiva’s APS IgG & APS IgM reagents, expanding its portfolio from Celiac Diseases & CTD essential reagents to 18 FDA-cleared analytes The APS reagents semi-quantitatively detect anti-cardiolipin (aCL), plus anti-β2 glycoprotein 1 (aβ2GP1) IgG & IgM in serum levels, aiding in diagnoses of 1° & 2° APS…
January 14, 2025

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NEWS

Johnson & Johnson’s Reports the CE Mark Approval for Dual Energy Thermocool Smarttouch SF Catheter for Cardiac Arrhythmias

Shots: The CE mark of Thermocool Smarttouch SF Catheter for cardiac arrhythmias was based on SmartfIRE trial in European patients with refractory PAF that depicted 100% acute success rate & first-pass isolation achievement in 96.8% of veins (published in Apr 2024). The Trupulse Generator hardware compatibility is anticipated in H1’25 The company has concluded…
January 13, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (January 06, 2025 – January 10, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & Biotech. Check out our full report below:     Oculis Reports Results from P-II (ACUITY) Study of OCS-05 for Treating Acute Optic Neuritis Read More: Oculis PharmaEssentia Reports Topline Data from P-III (SURPASS-ET) Trial of Ropeginterferon Alfa-2b-Njft (P1101) in Essential…
January 10, 2025

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NEWS

Simpson Interventions Receives the US FDA’s 510(k) Clearance for its Shadow Catheter and IDE Approval for its Acolyte Catheter System

Shots: Simpson Interventions reported the grant of IDE by the US FDA to Acolyte Image-Guided Crossing & Re-Entry Catheter System plus 510(k) clearance for its Shadow Catheter Acolyte System intends to enables cardiologists with revascularization of coronary chronic total occlusion (CTO). In Mar 2024, it was designated with the US FDA’s BDD and included…
January 8, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (December 30th, 2024 – January 03rd, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & Biotech. Check out our full report below:     Novartis Reports Data from P-III (STEER) Study of Onasemnogene Abeparvovec to Treat Children and Young Adults with Spinal Muscular Atrophy (SMA) Read More: Novartis CARsgen Therapeutics Reports Topline Results from P-II…
January 3, 2025

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NEWS

The China’s NMPA Grants Approval to Genesis Medtech’s Articulation Powered Stapler, iReach Omnia, for Complex Surgeries

Shots: The NMPA has approved iReach Omnia for market release, enhancing precision and access in complex laparoscopic surgeries The iReach Omnia transforms surgical stapling with 90° articulation, offering precision and maneuverability in confined spaces. It minimizes staple line weak points, reduces anastomotic leakage risks & enhances outcomes in complex procedures like colorectal and thoracic…
January 3, 2025

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Exclusive_Kyle Forcier_2022
EXCLUSIVE

Kyle Forcier, Senior Director of Life Sciences Product Marketing at Model N Shares Insights on How Model N Helps Life Sciences Companies Navigate Greater Compliance Pressure

Shots: Kyle Forcier gave a detailed view of the Spring 2022 product release by Model N and how it will be a practical solution for the Pharmaceutical and MedTech companies Kyle also spoke about Model N’s Revenue Cloud, which can empower MedTech Sales with better revenue recognition The interview gives a glimpse of Model N’s…
July 11, 2022

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