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NEWS

Lumos Labs Reports the US FDA Clearance of LumosityRx for ADHD Patients

Shots: The US FDA has granted 510(k) clearance to LumosityRx, a prescription digital therapeutic, designed to improve attention in adults (22-55yrs.) with attention deficit hyperactivity disorder (ADHD) Assessed in the GAMES Study (n>500), LumosityRx showed significantly improved TOVA Attention Comparison Score (1EP) vs a control app, with 44.2% pts achieving clinically meaningful attention gains (>1.4 points…
December 11, 2025

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NEWS

Resmed Receives FDA Clearance for Smart Comfort, an AI-Enabled Tool to Personalize CPAP Therapy

Shots: Resmed received FDA clearance for its AI-enabled Smart Comfort for PTCS (Personalized Therapy Comfort Settings), the first FDA-cleared device for personalized comfort settings for obstructive sleep apnea (OSA) pts start and stay on CPAP therapy US rollout begins in limited beta versions for new users of myAir users in early 2026, followed by broader availability…
December 9, 2025

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Neuraxpharm and mjn-neuro to launch Episeras for Early Detection of Epileptic Seizures

Shots: Neuraxpharm & mjn-neuro will launch Episeras for real-time early seizure detection in ambulatory & homecare settings, with EU rollout planned for the H2’26 EPISERAS is being evaluated in the ongoing multicentre SERAS-Home_RWD study across Spain, the UK, & Germany, with interim data currently in preparation for publication Episeras is a non-invasive device that monitors…
November 27, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Nov 10, 2025 – Nov 14, 2025)     

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below:     Ionis Highlights P-III (CORE & CORE2) Trials Results of Olezarsen for Severe Hypertriglyceridemia (sHTG) at AHA 2025  Read More: Ionis  AstraZeneca Reports P-III (NATRON) Trial Data on Fasenra (Benralizumab) to Treat Hypereosinophilic Syndrome (HES) …
November 14, 2025

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NEWS

Doc.com Launches AI & Blockchain Telemedicine Platform in the US

Shots: Doc.com launches its AI & blockchain-powered telemedicine platform in the US to improve patient access, data security, & care coordination Pts can securely connect with licensed in-state healthcare providers via mobile using the platform, with up to 15min. of complimentary teleconsultation offered during launch, available in eligible jurisdictions & subject to applicable regulations, followed…
November 12, 2025

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NEWS

Minze Health Partners with Medtronic to Expand Digital Bladder Monitoring Across EMEA

Shots: Minze Health has entered into a 3yr. agreement with Medtronic to commercialize its Minze Diary Pod, an automated bladder diary solution, across the EMEA region Partnership will integrate the Diary Pod into the Sacral Neuromodulation (SNM) care pathway for pts with Overactive Bladder (OAB) receiving Medtronic’s InterStim therapy, allowing objective data collection during diagnosis…
November 12, 2025

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NEWS

INBRAIN Neuroelectronics Partners with Microsoft to Advance AI-Enabled Brain-Computer Interface Therapeutics

Shots: INBRAIN Neuroelectronics has entered into a strategic collaboration with Microsoft to apply agentic AI powered by Microsoft’s cloud & data infrastructure to enhance real-time precision neurology & next-gen brain-computer interface (BCI) therapeutics The partnership will leverage Microsoft’s Azure AI infrastructure, incl. time-series large language models & data analytics with INBRAIN’s graphene-based neural platform, allowing…
November 11, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Nov 03, 2025 – Nov 07, 2025)

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below:     Daiichi Sankyo Reports First Patient Dosing in P-III (DESTINYLung06) Trial of Enhertu + Keytruda to Treat HER2 Overexpressing Non-Squamous NSCLC  Read More: Daiichi Sankyo  Genentech Reports P-III (ALLEGORY) Trial…
November 7, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Oct 27, 2025 – Oct 31, 2025)

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below:    Roche Reports P-III (INShore) Trial Findings on Gazyva (Obinutuzumab) for Idiopathic Nephrotic Syndrome Read More: Roche Merck Reports the P-III (LITESPARK-022) Trial Data on Welireg + Keytruda to Treat Clear…
October 31, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Oct 21, 2025 – Oct 24, 2025)    

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below:    Daiichi Sankyo and Merck Report the P-II Study Data for Raludotatug Deruxtecan in Pt.-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer  Read More: Daiichi Sankyo and Merck  Gilead…
October 24, 2025

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