Exclusives

Spectral AI announces it has achieved 25% of patient enrollment at emergency depts (EDs) for its US Burns Pivotal Study and added 2 more clinical sites, expanding to 11 ED facilities. The company plans to pursue a De Novo submission for...

Med Way Inc received FDA 510(k) clearance for V-Move and V-Grand NPWT products indicated for chronic, acute, traumatic, subactute, dehisced wounds, partial-thickness burns, ulcers, flaps and grafts using extriCare 3600 and VCare 10000-300S...

Convatec is progressing in generating and disseminating clinical evidence for InnovaMatrix AC. Results from the 1st phase of its RWE, including VLUs, DFUs and other indications, will be published in H224 and H125. Its 120-patient clinical...

A study of lower extremity lymphedema in 143-patients at the VA found that using advanced pneumatic compression devices (Flexitouch) improved all domains of QoL score after 12 weeks of treatment and through a 52-week follow-up. JVS-VL

A 120-patient RCT will examine the efficacy of porcine placental extracellular matrix as an adjunct to SoC vs SoC alone for hard-to-heal VLUs with the primary outcome being percentage of ulcer closure at 12 weeks. Not yet recruiting;...

Cork Medical received an updated FDA 510(k) clearance for their VERSA NPWT system. The updated clearance has the same indication but expands the use to both healthcare facilities and home use environments, as well as making updates to display...

MiMedx initiated a 170-patient study to evaluate 2 human amnion/chorion membrane (ppLHACM) products, EPIEFFECT and EPIXPRESS and SoC vs SoC alone in the treatment of non-healing DFUs. Primary outcome measures complete healing in 12 wks....

A 20-patient pilot clinical trial will evaluate the use of borate-based bioactive glass fiber matrix (Mirragen) for treatment of DFUs with primary outcome of complete wound closure at 12 weeks. Not yet recruiting; estimated study completion...