Skip to content Skip to footer
Subscribe Now
Fresenius Kabi
NEWS

Fresenius Kabi Reports the US FDA’s 510(k) Clearance for Adaptive Nomogram, Improving Plasma Collection Efficiency

Shots: The US FDA has granted 510(k) clearance to Adaptive Nomogram algorithm in the Aurora Xi Plasmapheresis System to improve plasma collection efficiency Clearance was based on a trial of Adaptive Nomogram in Aurora Xi Software Version 2.0 vs the existing Optimized Nomogram involving >52,400 procedures that met its 1EP, depicting increased plasma volume…
January 29, 2025

Read more

NEWS

ClearPoint Neuro Receives US FDA’s 510(k) clearance for ClearPoint Navigation Software Version 3.0

Shots: The US FDA has granted 510(k) clearance to ClearPoint Navigation Software 3.0 that will introduce intraoperative CT workflow, expanding its use from MRI. The company is planning to initiate limited market release in Q1’25 & full release in H2’25 Navigation Software 3.0 is compatible with intraoperative CT & Conebeam CT imaging, enabling precision neurosurgery in facilities…
January 28, 2025

Read more

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (January 20, 2025 – January 24, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, DigiHealth, MedTech, Biosimilars, Animal Health & Biotech. Check out our full report below:         Novo Nordisk Reports Headline Results from P-IIIb (STEP UP) Study of Semaglutide 7.2mg in Obese Adults without Diabetes  Read More: Novo Nordisk  Yoltech Initiates a Dose-Escalation Study for YOLT-204 to Treat…
January 24, 2025

Read more

NEWS

Medidata (Dassault Systèmes brand) and Tigermed Expand their Strategic Collaboration to Expedite Clinical Trials Globally

Shots: Medidata and Tigermed have expanded their 13yrs. collaboration to leverage the former’s Medidata Platform across all trial phases, enhancing workflows, regulatory compliance & delivery of therapies globally Tigermed will integrate the platform with their workflow, automate data capture, streamline operations to enhance trial efficiency for accelerating time to commercialize new therapies The…
January 24, 2025

Read more

Roche
NEWS

Roche Receives 510(k) Clearance & CLIA Waiver for Cobas Liat Multiplex Assay Panels to Diagnose Sexually Transmitted Infections

Shots: The US FDA has granted 510(k) clearance & CLIA waiver for Cobas liat STI multiplex assay panels (CT/NG & CT/NG/MG), commercially available under the CE mark in upcoming months The CT/NG (chlamydia & gonorrhea) & CT/NG/MG (chlamydia, gonorrhea & Mycoplasma genitalium) assays compliment the existing portfolio of singleplex & multiplex tests of Cobas liat…
January 22, 2025

Read more

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (January 13, 2025 – January 17, 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:     Bayer Reports Topline Data from P-III (QUANTI) Trials of Gadoquatrane for its Use in MRI Read More: Bayer Oryzon Reports Dosing of the First Patient with Iadademstat + Venetoclax + Azacitidine…
January 17, 2025

Read more

NEWS

Sutter Health Collaborates with GE HealthCare to Enhance Patient Care Through AI-Powered Imaging for Physicians and Clinicians

Shots: Sutter Health and GE HealthCare signed a 7yrs. strategic collaboration agreement (Care Alliance), to enhance access to imaging services for patient and clinician experiences in California. This will enable faster appointments, quicker imaging results, and more consistent care Sutter Health's key initiatives include a fast technology program to deploy advanced AI imaging tools…
January 17, 2025

Read more

NEWS

NEXTBIOMEDICAL Secures the US FDA’s IDE Approval of Nexsphere-F to Use it in Genicular Artery Embolization (GAE) for Knee Osteoarthritis

Shots: The US FDA has granted IDE approval to initiate RESORB clinical evaluation of Nexsphere-F for knee osteoarthritis. It is CE-MDD approved for arthritis embolization & has shown superior efficacy in various musculoskeletal embolization cases across Asia & the EU RESORB study will evaluate the efficacy of Nexsphere-F to ease pain & improve mobility…
January 16, 2025

Read more

Load more