MedTech News
.................... by Andrew Celentano
Reactivating a fetal gene enables adult heart cells to regenerate after injury
Around the globe, heart disease remains one of the top causes of death. Once patients begin to suffer from serious heart problems, like heart attacks and heart failure, the heart muscles become damaged and are difficult to treat and repair.
BD gains FDA clearance and CE mark for bacterial panels on COR System
The panels employ PCR techniques to test for numerous gastrointestinal bacterial pathogens using one stool swab.
Sofinnova spinoff Tulyp Medical emerges from stealth with perfusion tech
Having already submitted an application with the FDA, Tulyp is now eyeing a Series A financing round to capture more clinical data and advance R&D.
Aqua Medical wins FDA IDE to launch trial for ablation procedure that treats diabetes
Aqua Medical has received an investigational device exemption (IDE) from the FDA for its ablation device intended to treat diabetes, the company told MassDevice ahead of an official announcement later today.
Fujifilm Sonosite launches new clamshell portable ultrasound system
Fujifilm Sonosite announced today that it launched the Sonosite MT, its latest portable ultrasound system offering.
Bioelectrochemical crossbar architecture screening platform for extracellular electron transfer
Bioelectronic devices link microbes and materials to convert chemical signals into electrical outputs for sensing, energy, and synthesis. Unlocking this potential requires systems that can interrogate electroactive cells rapidly and at scale, but traditional bioelectrochemical platforms remain costly, bulky, and low throughput.
Self-aligning mechanism for wearable biomechanical energy harvesters
The increasing demand for real-time, wireless, and sustainable motion monitoring in applications such as personal health, professional sports, and human-machine interactions calls for wearable devices that are lightweight and battery free.
QuidelOrtho Receives FDA 510(k) Clearance for VITROS™ Immunodiagnostic Products hs Troponin I Assay
SAN DIEGO, Nov. 3, 2025 /PRNewswire/ — The U.S. Food and Drug Administration (“FDA”) has granted QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a global leader of in vitro diagnostics, 510(k) clearance for the VITROS hs Troponin I Reagent Pack (the “VITROS hs Troponin I Assay”). The assay is intended for the quantitative measurement of cardiac troponin I (cTnI) in human plasma (heparin) to aid in the diagnosis of myocardial infarction (MI).