All articles by Amit Thadani
Amit Thadani
DePuy Synthes Receives FDA Clearance for TELIGEN™ System
New MedTech Advancement Brings First-of-Its-Kind Technology to Spine Surgeons, Delivering Advanced Visualization and User-Centric Procedural Control
FDA Accepts NMP’s Clinical Trial Application for Development of NMK89 as Imaging Agent for Cancer Diagnosis
– Clinical Study Set to Begin, Focusing on Diagnostic Use of Theranostics –
Groundbreaking Pilot of New Friendly™ Mosquitoes Demonstrates 96% Suppression of Dengue-spreading Aedes aegypti in Urban Communities in Brazil
OXFORD, England — Oxitec Ltd, a leading developer of biological pest control solutions, today announced the scientific publication of results from groundbreaking large-scale pilot releases of its new male-only, female-lethal Friendly™ Aedes aegypti solution in the Brazilian city of Indaiatuba. Deployments of non-biting male Friendly™ Aedes aegypti over 11 months in densely populated, dengue-impacted urban communities led to significant suppression of the resident pest Aedes aegypti population by up to 96%. This level of efficacy against a difficult-to-control, disease-spreading mosquito, demonstrated in 2018 and 2019, laid the groundwork for a new class of mosquito control products that use the Friendly™ Aedes aegypti technology in simple, scalable, “just-add-water” form factors that require no special training to deploy. Those products are being launched commercially in Brazil right now.
RZNOMICS Inc. received FDA approval to initiate clinical development of trans-splicing ribozyme-based RNA editing technology in liver cancer patients
SEONGNAM, South Korea — Rznomics Inc., a South Korea based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, recently received Phase 1/2a IND approval from the U.S FDA in October 10th for its hepatocellular carcinoma (HCC) treatment called RZ-001 and thus has achieved an important milestone for the company and the RNA editing field. Being the first U.S. FDA-approved ribozyme-based RNA reprogramming approach to be evaluated in patients, RZ-001, a gene therapy approach utilizing the company’s proprietary trans-splicing ribozyme-based RNA reprogramming and editing technology, is a replication-incompetent adenoviral vector that expresses an hTERT targeting ribozyme with multiple additional MoA to treat HCC patients. Rznomics also received IND approval of RZ-001 from the South Korean Ministry of Food and Drug Safety this June and already initiated a phase 1/2a clinical trial in Korea. Therefore, U.S. FDA approval allows Rznomics to start an international clinical study in HCC patients treating them with RZ-001 and therapeutic RNA editing.
SQI Diagnostics Announces Health Canada Approval of RALI-Dx Severity Triage Test
TORONTO – SQI Diagnostics Inc. (TSXV: SQD) (OTCQB: SQIDF), a leader in the science of lung health that develops and manufactures respiratory health and precision medicine tests, today announced it has received Health Canada Interim Order authorization for its Rapid Acute Lung Injury Diagnostic (RALI-Dx™) IL-6 Severity Triage Test. RALI-Dx™ is the first interleukin-6 (IL-6) diagnostic test approved in Canada, and its turnaround time of less than an hour is developed to fill an important and unmet public health need.
Medtronic first to receive FDA approval for pacing the heart’s natural conduction system
Medtronic “conduction system pacing” expanded indication now includes left bundle branch area pacing in addition to His-Bundle pacing for patients with slow heart rates
Australia Begins a Big Push to Sequence Underserved Populations
Illumina will support the OurDNA initiative to improve disease prediction, diagnosis, and treatment
Randox collaborate with Verv Technologies to Improve Health for All
Randox Laboratories, the largest diagnostics company from the UK, are proud to announce a $3.8m CAD seed round with Verv Technologies.
Roche to introduce its next-generation portfolio of SARS-CoV-2 rapid antigen tests (“2.0”) under CE Mark for self-test and professional use
Basel, 12 October 2022- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of its next-generation portfolio SARS-CoV-2 rapid antigen tests (“2.0”) for self-testing and professional use in countries accepting the CE Mark. Distribution of the new rapid test portfolio is projected to begin in the coming weeks.
Thermo Fisher Scientific Launches CE-IVD Marked Panel to Detect Most Common Gastrointestinal Bacteria
CARLSBAD, Calif.–(BUSINESS WIRE)– Thermo Fisher Scientific, the world leader in serving science, today announced the launch of the TaqPath Enteric Bacterial Select Panel, a CE-IVD marked panel designed to detect common gastrointestinal (GI) bacteria and help enable clinicians to identify the root cause of an infection and administer the most appropriate treatment to their patients more quickly. The panel was validated and registered under IVDD in May 2022.