Cresilon Inc. obtained U.S. FDA clearance for a hemostatic gel that staunches the flow of blood from minor external wounds. The Cresilon hemostatic gel (CHG) is the first technology to blend polymers from the algae plant to instantaneously create a mechanical barrier against bleeding.
Theralase Technologies Inc. has pioneered technology said to selectively infiltrate and kill non-muscle invasive bladder cancer (NMIBC) at the cellular level. Bladder cancer generally is the 10th most common cancer in the world (6th in men and 17th in women), and gradually showing up in greater numbers in other patient groups.
Astek Diagnostics Inc. has wound up a successful $2 million early stage VC funding round to support the development and launch of a medical device designed for the speedy recovery of patients suffering from urinary tract infections (UTI). The Baltimore-based startup has designed a benchtop analyzer and disposable cartridge called the Jiddu that can detect bacterial infection in urine in one hour.
University of Chicago spinoff Flow Medical Inc. is finalizing its design of a multi-function catheter to diagnose and treat venous thromboembolic disease – boosted by a $1 million private investment to commercialize the device.
Whoever said beauty is only skin deep hasn’t looked below to see what Sientra Inc. has made available there recently. The medical aesthetics company now boasts the only tissue expander cleared in the U.S. for exposure to magnetic resonance imaging, an important screening tool for breast reconstruction patients. Sientra’s CTO Denise Dajles told BioWorld the newly cleared Allox2 Pro Tissue Expander builds on the original expander also cleared by the FDA. “No other expander in the market has an MRI compatibility indication because they are based on a metal, i.e., metallic ports and big magnets in them,” Dajles explained.
Asep Medical Holdings Inc. reported “ground-breaking” use of artificial intelligence in its SepsetER test to rapidly identify infections at increased risk of severe sepsis. Developed under guidance by Professor Robert E.W. Hancock at the University of British Columbia, analysis of dysfunctional immune responses to identify particular sets of genes could signal when a patient is at risk of acquiring and potentially dying from severe sepsis.
They call it the world's “first fully integrated wearable” ultrasound system for evaluating cardiovascular function while you walk, run, even ride a bicycle. Built on the nanoengineering research at the University of California San Diego (UCSD) the wearable ultrasonic system-on-patch (USoP) employs machine learning to interpret deep tissue vital signs data and track subjects in motion.
If Orlucent Inc. has its way atypical moles in adults will soon give up their secrets to clinicians on the lookout for skin cancer, this after the Los Gatos, Calif.-based company received a U.S. FDA breakthrough device designation for its non-invasive Orlucent skin fluorescence imaging system. The system is a hand-held point-of-care molecular-based imaging device that identifies “tissue remodeling activity” inside atypical moles that could be a precursor to early melanoma.
A surgical navigation platform developed by Proprio Inc., that is intended to replace traditional surgical technologies which produce harmful radiation and can impede surgical workflow, won U.S. FDA 510 (k) clearance.
Centricity Vision Inc. received U.S. FDA clearance for technology designed to integrate with modern phacoemulsification or “phaco” systems that use ultrasound energy to emulsify the eye's native internal lens during cataract surgery. Centricity’s new Zeptolink interocular lens (IOL) positioning system is used in conjunction with phaco systems to surgically remove the natural lens of the eye as the first step in cataract surgery.
