Skip to content
Synopulse
  • The Brief
    • Quick
    • In Depth
    • Editor’s Pick
    • Findings
  • Reports
    • The beats
      • Catalyst
      • AccessWatch
      • DealPulse Signal
      • DealPulse Report
    • Analysis
      • The Throughline
      • The Top Line
      • The Forecast
    • Coverage
      • ShowFloor
      • The Arena
  • The Pulse
    • NeuroPulse
    • OrphanPulse
  • Topics
    • By subject
      • Deals
      • Regulatory
      • Market Access
      • Pricing & Reimbursement
      • Legal & Policy
    • By technology
      • Antibody
      • Cell & Gene Tx
      • Drug conjugates
      • AI/ML
      • Digital Health
      • Radiopharma
    • By therapy area
      • Neurology
      • Oncology
      • Rare Diseases
      • Cardio-Metabolic
      • Immunology & Inflammation
      • Orthopaedics

510(K)

One Robot, Three Ways In: Momentis Clears Multiport a Day After J&J Shrank the Footprint

July 23, 2026 by Athithi Verma
One Robot, Three Ways In: Momentis Clears Multiport a Day After J&J Shrank the Footprint

Momentis won FDA clearance for multiport surgery, making Anovo the first robotic platform cleared for natural orifice, single-port and multiport approaches.

Categories Approval, CI read, MedTech, Quick, The Brief Tags 510(K), Anovo, Gynecology, Intuitive Surgical, Johnson & Johnson, MedTech, Momentis Surgical, Surgical Robotics

A Company Called StrokeDx Just Cleared a Device That Is Not Cleared to Detect Stroke

July 23, 2026 by Athithi Verma
A Company Called StrokeDx Just Cleared a Device That Is Not Cleared to Detect Stroke

NeuraNova, formerly StrokeDx, won FDA clearance for a bedside device measuring cerebral fluid asymmetry, cleared as an adjunct rather than a diagnostic.

Categories CI read, MedTech, Quick, The Brief Tags 510(K), MedTech, NeuraNova, Neurotech, STEDI, Stroke

Digital Pathology Clearance Accelerates U.S. Market Entry

June 25, 2025 by Shajini

PathPresenter wins FDA clearance for digital pathology viewer, advancing primary diagnosis and LIS integration.

Categories News Tags 510(K), Digital Pathology, FDA, FDA cleared digital pathology system
Synopulse Weekly Pulse: Access Decisions, Regulatory Events & Market Dynamics, Week of Nov 24 2025

Synopulse Weekly Pulse – November 24, 2025

Read Now
  • Access Read
  • AI/ML
  • Analysis
  • Antibody
  • Approval
  • Cardio-Metabolic
  • Cell & Gene Tx
  • CI read
  • Clinical Read
  • Coverage
  • Deal Read
  • DealPulse
  • DealPulse Report
  • DealPulse Signal
  • Deals
  • Diagnostics
  • Digital Health
  • Drug conjugates
  • Drug Repurposing
  • Editor's Pick
  • Findings
  • Immunology & Inflammation
  • In Depth
  • Launch
  • Legal & Policy
  • Market Access
  • MedTech
  • Neurology
  • NeuroPulse
  • News
  • Oncology
  • Ophthalmology
  • Organ On Chip
  • OrphanPulse
  • Orthopaedics
  • Peptide
  • Pricing & Reimbursement
  • Pulmonology
  • Quick
  • Radiopharma
  • Rare Diseases
  • Regulatory
  • Reports
  • RNA
  • Science Read
  • ShowFloor
  • Small Molecule
  • The beats
  • The Brief
  • The Pulse
  • The Throughline
  • September 2026
  • August 2026
  • July 2026
  • June 2026
  • May 2026
  • March 2026
  • January 2026
  • December 2025
  • November 2025
  • October 2025
  • September 2025
  • July 2025
  • June 2025
  • February 2025
  • January 2025
  • October 2024
  • September 2024
Synopulse
Contact Us

Explore Synopulse

  • NeuroPulse
  • Deals
  • Market Access
  • Industry Trends
  • Regulatory

About

  • About Synopulse
  • Contact Us
  • Announcements
© 2026 Synopulse • Built with GeneratePress