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Evaxion Launches AI-Powered Vaccine Program Against Group A Streptococcus

AI
  • Evaxion A/S has initiated development of EVX-B4, a new preventive vaccine targeting Group A Streptococcus (GAS), which causes hundreds of millions of infections globally each year.
  • The company's AI-Immunology™ platform successfully identified novel vaccine targets against GAS through initial computational analysis, potentially offering a new approach to combat this bacterial pathogen.
  • GAS infections range from mild conditions like strep throat to life-threatening diseases including necrotizing fasciitis and rheumatic heart disease, with no current preventive vaccine available.
  • The addition of EVX-B4 expands Evaxion's pipeline to eight vaccine candidates total, supporting the company's partnership strategy for out-licensing opportunities.

ForSight Robotics Raises $125M Series B to Advance ORYOM Robotic Eye Surgery Platform

AI
  • ForSight Robotics completed a $125M Series B funding round led by Eclipse to accelerate development of the ORYOM Platform, the world's first robotic surgery system for cataract and other eye diseases.
  • The company plans to launch first-in-human clinical trials this year, addressing a global crisis where over 600 million patients suffer from cataracts but only 30 million receive surgical treatment annually.
  • The ORYOM Platform utilizes AI-based algorithms, advanced computer vision, and micromechanics to provide unprecedented precision for ophthalmic procedures, with capability to access both anterior and posterior eye segments.
  • The funding brings ForSight Robotics' total funding to $195M as the company doubles in size to over 110 employees and prepares to tackle the projected 12% decline in ophthalmologists by 2035.

Abridge Secures $300M Series E Funding, Reaches $5.3B Valuation for AI Clinical Documentation Platform

AI
  • Abridge raised $300 million in Series E funding led by Andreessen Horowitz, bringing its valuation to $5.3 billion for its ambient listening technology that automates clinical documentation.
  • The AI-powered platform serves over 150 health systems including Kaiser Permanente, UPMC, and Sutter Health, generating clinical notes from medical conversations across 55 specialties and 28 languages.
  • The company reports significant clinical impact with 60-70% reduction in burnout and over 90% clinician retention rate, while projecting support for more than 50 million medical conversations in 2025.
  • This funding round follows a $250 million raise in February, representing one of the most substantial health tech deals of 2024 as AI scribes gain rapid adoption to address clinician burnout.

MindRank's AI-Designed Oral GLP-1 Drug Achieves 10.3% Weight Loss in Phase 2b Trial

AI
  • MindRank's AI-designed oral GLP-1 receptor agonist MDR-001 demonstrated statistically significant weight reductions of 8.2% to 10.3% at 24 weeks compared to 2.5% with placebo in a Phase 2b trial.
  • The drug showed excellent tolerability with no treatment-related serious adverse events and only 0.8% discontinuation rate due to adverse events.
  • MDR-001 represents the first AI-designed oral GLP-1 receptor agonist to report positive Phase 2b data globally, positioning it for Phase 3 development.

A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities

NCT05051579CompletedPhase 2
Eli Lilly and Company
Posted 9/29/2021

A Study to Evaluate the Efficacy and Safety of MDR-001 in Subjects Who Are Obesity or Overweight

NCT06606483Not Yet RecruitingPhase 2
MindRank AI Ltd
Posted 9/23/2024

Smart Soft Healthcare's CoLumbo AI Spine Assistant Receives FDA Clearance for Enhanced Scoliosis and Fracture Detection

AI
  • Smart Soft Healthcare announced FDA 510(K) clearance for CoLumbo Version 3, an advanced AI spine assistant that expands diagnostic capabilities for spinal conditions.
  • The latest version introduces support for DICOM images of patients with scoliosis and fractures, building on the platform's previous FDA clearance for lumbar spine MRI analysis.
  • CoLumbo Version 3 provides comprehensive assistance in measuring and reporting spinal conditions, offering greater reliability for radiologists and improved patient outcomes.
  • The regulatory milestone strengthens CoLumbo's position as a pioneering tool in spine imaging and broadens its clinical application scope in radiology practices.

OutSee Secures £1.8M Seed Funding to Advance AI-Powered Genomics Platform for Drug Discovery

AIDrug Discovery
  • Cambridge-based OutSee raised £1.8M in seed funding led by Ahren Innovation Capital to advance its proprietary AI platform Nomaly for predictive genomics drug discovery.
  • The company's Nomaly technology uses hypothesis-free modeling to predict disease and phenotype directly from single genomes, enabling target discovery from smaller datasets previously considered too complex to interpret.
  • OutSee plans to expand its in-house target pipeline focusing on CNS disorders, rare diseases, and metabolic conditions while establishing partnerships with major pharmaceutical and biotech companies.
  • The funding builds on over £500K in Innovate UK grants and partnerships with Genomics England and FinnGen, positioning the company to transform therapeutic target identification.

Sonrai Analytics Partners with Plectonic Biotech to Advance AI-Driven Logic-Gated Antibody Cancer Immunotherapies

AIPrecision Medicine
  • Belfast-based AI specialist Sonrai Analytics has partnered with German biotech Plectonic Biotech to accelerate development of logic-gated antibody immunotherapy technology across multiple cancer types.
  • The collaboration will leverage Sonrai's AI-driven multi-modal approach integrating single-cell RNA sequencing with proteomic mass spectrometry to identify ultra-specific antigen combinations for tumor targeting.
  • Plectonic's proprietary Logibody technology acts as a molecular switch that triggers antibody-mediated immune responses only in the presence of specific tumor antigens, aiming to increase treatment precision while reducing toxicity.
  • The partnership combines Sonrai's advanced data science capabilities with Plectonic's DNA nanotechnology to fast-track development and accelerate the path to clinical trials.

DeepEcho Receives FDA 510(k) Clearance for AI-Powered Fetal Ultrasound Analysis Platform

AI
  • The US Food and Drug Administration has granted 510(k) clearance to DeepEcho's AI-powered fetal ultrasound analysis platform, marking a significant milestone in prenatal care technology.
  • The platform utilizes advanced deep learning algorithms trained on one of the world's largest fetal ultrasound datasets to automate real-time detection of fetal ultrasound views and improve diagnostic accuracy.
  • DeepEcho is developing next-generation solutions to identify novel biomarkers for early prediction of complex conditions like preeclampsia, a leading cause of maternal and neonatal mortality.
  • The company aims to democratize access to quality fetal ultrasound diagnostics globally, addressing critical challenges from diagnostic variability in developed markets to skilled radiologist shortages in emerging regions.

PathAI Receives FDA Clearance for AISight Dx Digital Pathology Platform for Primary Diagnosis

AI
  • PathAI announced FDA 510(k) clearance for its AISight Dx digital pathology platform for primary diagnosis in clinical settings, building on initial clearance received in 2022.
  • The FDA decision includes a Predetermined Change Control Plan (PCCP) that allows PathAI to implement major changes like additional displays, scanners, and file formats without requiring new 510(k) submissions.
  • AISight Dx is a cloud-native platform designed to modernize anatomic pathology workflows through intelligent case management, high-performance slide review, and seamless collaboration capabilities.
  • The platform is FDA-cleared for use with Hamamatsu NanoZoomer S360MD and Leica Aperio GT 450 DX slide scanners, offering interoperability for organizations of any size.

LifePlus Achieves Clinical Validation for Revolutionary Non-Invasive Glucose and Blood Pressure Monitoring Device

AI
  • LifePlus announced clinical validation of LifeLeaf®, the world's first non-invasive wearable for continuous glucose and blood pressure tracking, tested at Mayo Clinic, Cleveland Clinic, and other global centers.
  • The device achieved impressive accuracy with 10.8% MARD against blood glucose meters and 8.5% MARD against Dexcom G6, while demonstrating blood pressure monitoring accuracy within ±12.5 mmHg systolic and ±8.4 mmHg diastolic.
  • Clinical validation was supported by over 70,000 paired multi-biomarker datapoints from more than 500 subjects across 14 countries, with the device being 70% more cost-effective than current solutions.
  • LifePlus is initiating additional longitudinal outcome studies across multiple continents, targeting prediabetic and hypertensive populations to demonstrate early intervention benefits.

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