Exclusives

Organogenesis announced plans to expand manufacturing capacity at a 122K sq ft biomanufacturing facility in Smithfield, RI. ORGO will continue to operate its HQ and manufacturing facilities in Canton, MA and other operations in the US and...

Spectral AI announces that its DeepView SnapShot M device continues to develop based on preliminary feedback from its usability study with the Brooke Army Med Center and US Army Medical Research and Development Institute. The company plans to...

BioStem announced it signed a Letter of Intent (LOI) to acquire commercial-stage products and development technologies from ProgenaCare in support of its portfolio diversification strategy. After due diligence, BSEM expects to finalize the...

WOUND-Q, a patient-reported instrument to measure outcomes for individuals with non-healing chronic wounds, has been qualified through the Medical Device Development Tools program. The MDDT program is a way for the FDA to qualify tools for...

Kerecis is sponsoring a 150-patient RCT (THOR) to evaluate intact fish skin graft (MariGen) and SoC vs SoC alone for treatment of VLUs with primary outcome of percent of ulcers having complete closure at 12 weeks. Not yet recruiting;...

MediWound is sponsoring a 45-patient RCT to evaluate the safety and efficacy of EscharEx and placebo vs Collagenase for treatment of VLUs with primary outcome of changes in parameters and percent and time to wound closure at 2-15 weeks....

MIMOSA Diagnostics has welcomed the CMS expansion of the definition of standard of care vascular assessment requirements to include tissue oxygenation in their final LCD ruling for skin substitutes for diabetic foot ulcers and venous leg...

Cardinal announced the US launch of its Kendall SCD SmartFlow, the next generation of Kendall’s SCD Compression Series, designed to help prevent VTE events, enhance blood circulation and treat pain and swelling related to venous stasis.