Diagnostics

NeuroPace Feasibility Study of Its RNS System for Lennox-Gastaut Syndrome Now Underway

12/09/2022

First patient receives brain-responsive neuromodulation for LGS, a severe and disabling childhood-onset epilepsy Excerpt from the Press Release: MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–NeuroPace, Inc. (Nasdaq: NPCE), a commercial-stage medical device company focused on transforming the lives of people living with epilepsy, today announced that the first patient with Lennox-Gastaut Syndrome (LGS) was treated in its feasibility…

Read More

Biological Dynamics collaborates on clinical utility studies to examine the impact of its early pancreatic cancer detection assay

11/29/2022

The company partners with QURE and Curta to assess value of early identification in high-risk cohorts Excerpt from the Press Release: SAN DIEGO, Nov. 22, 2022 /PRNewswire/ — Biological Dynamics, an exosome-isolation technology and early disease detection diagnostic company, today announced that it has partnered with both QURE Healthcare and Curta to explore how the…

Read More

Sight Sciences Announces Publication of Clinical Data Demonstrating Standalone Effectiveness of the OMNI® Surgical System in Pseudophakic Glaucoma Patients with Uncontrolled Pressure Following a Previous Combination Cataract Stent Procedure

11/11/2022

Multicenter Clinical Data from Five US sites Published in International Ophthalmology Excerpt from the Press Release: Worldwide, more than one million trabecular microbypass stents have been implanted in combination with cataract surgery. Despite glaucoma medications and prior microbypass stenting, target IOP may no longer be achieved over time. During 3 to 42 months follow-up, the…

Read More

TRANSPLANT GENOMICS PRESENTS TRUGRAF® LIVER AT THE AMERICAN ASSOCIATION FOR THE STUDY OF LIVER DISEASES

11/10/2022

TruGraf® Liver is a novel gene expression biomarker diagnostic test used to confirm immune quiescence and rule out organ rejection for liver transplant recipients. Excerpt from the Press Release: FRAMINGHAM, Mass., Nov. 3, 2022 /PRNewswire/ — Transplant Genomics (“TGI”), the transplant rejection diagnostics company committed to improving organ transplant outcomes worldwide, will be attending The…

Read More

Hologic’s 3Dimensions™ System for 3D Mammography Receives EUREF Type Test Certification

11/08/2022

3Dimensions System Earns Distinction for Meeting or Exceeding Rigorous European Image Quality and Dose Standards Excerpt from the Press Release: MARLBOROUGH, Mass.–(BUSINESS WIRE)–Hologic, Inc. (Nasdaq: HOLX), a global leader in women’s health, announced today that its 3Dimensions™ mammography system was awarded EUREF Type Test certification by the European Reference Organisation for Quality Assured Breast Screening…

Read More

Mirum Pharmaceuticals Presents Long-Term LIVMARLI® (maralixibat) Data and New Alagille Syndrome Caregiver Burden Analysis at NASPGHAN 2022 Annual Meeting

10/21/2022

– Six-year natural history comparison with maralixibat demonstrates event-free and transplant-free survival in patients with Alagille syndrome (ALGS) – Characterization of four-year growth improvement in Alagille syndrome with maralixibat – New analysis evaluating health-related quality of life impact assessed on caregivers of children with Alagille syndrome – Mirum to host a scientific symposium on the…

Read More

Axcella Announces Positive Interim Data from Phase 2b EMMPACT Study of AXA1125 in Nonalcoholic Steatohepatitis (NASH)

10/07/2022

Subjects enrolled with biopsy confirmed NASH experienced clinically and statistically significant improvements in liver stiffness as measured by FibroScan, a non-invasive measure of liver fibrosis Subjects with NASH experienced clinically and statistically significant improvements in alanine aminotransferase (ALT), a measure of liver cell inflammation, at both dose levels of AXA1125 Findings demonstrate improvement in hepatic…

Read More

ImmunoGen Presents Comprehensive Updates for Mirvetuximab Soravtansine Combination Data in Ovarian Cancer at IGCS

10/07/2022

Mirvetuximab Plus Bevacizumab Demonstrated Meaningful Efficacy in Recurrent FRα-Positive Ovarian Cancer Across a Broad Range of FRα Expression Regardless of Prior Treatment; Data to be Highlighted in Oral Presentation Additional Clinical Benefit Outcomes from Pivotal SORAYA Study Also Reported Excerpt from the Press Release: WALTHAM, Mass.–(BUSINESS WIRE)–ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding…

Read More

The New England Journal of Medicine Publishes Pivotal Tofersen Data that Show Benefits in Rare, Genetic Form of ALS

10/03/2022

Publication includes the Phase 3 VALOR SOD1-ALS trial and its open-label-extension study, underscoring the importance of these longer-term data 12-month data show earlier initiation of tofersen slowed decline across critical measures of function and strength in people diagnosed with SOD1-ALS Results offer important learnings regarding the biology of SOD1-ALS and design of ALS clinical trials…

Read More

Iterative Scopes Receives FDA Clearance for AI-Assisted Polyp Detection Device SKOUT™

09/29/2022

SKOUT’s advanced computer vision capabilities enable physicians to detect pre-cancerous lesions in the colon with more accuracy Excerpt from the Press Release: CAMBRIDGE, Mass. & MINNEAPOLIS–(BUSINESS WIRE)–Iterative Scopes, a pioneer in precision medicine technologies for gastroenterology, and Provation, the premier software and SaaS provider of clinical productivity and workflow automation solutions, announced today that SKOUT™…

Read More