Entries by CAPTIS

Strata Skin Sciences adds license for excimer laser vitiligo treatment 

Strata Skin Sciences (NSDQ:SSKN) said it has reached an agreement with an “internationally acclaimed health institution” giving Strata an exclusive license to treat vitiligo using its Xtrac excimer laser. In a novel treatment for vitiligo, the excimer laser incrementally increases the light emitted in the UVB range to restore pigmentation to skin areas affected with […]

Seno Medical Instruments touts Imagio breast cancer subtype ID trial results

Seno Medical Instruments today released results from a study of its Imagio opto-acoustc imaging system intended to diagnose breast cancer, touting that both morphologic and functional OA/US features serve as a non-invasive approach to helping distinguish breast cancer molecular subtypes. Results from the study were presented late last month at the Radiological Society of North […]

LumiThera inks Italian Valeda distro deal

LumiThera said today that it inked a deal with ophthalmology distributor Miloftalmica to be the exclusive distributor of the Valeda light delivery system, intended to treat dry age-related macular degeneration, across Italy. Therapy using the Valeda light delivery system consists of a series of light-based treatments to the retinal cells, which Seattle-based LumiThera claims improves […]

BioCardia submits bid for FDA clearance of Avance transseptal introducer

BioCardia (NSDQ:BCDA) said today that it submitted an application for FDA 510(k) clearance for its Avance steerable introducer intended for introducing cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The San Carlos, Calif.-based company said the Avance device uses new technology developed for the company’s Morph line of […]

In2Bones intros ‘see-through’ implant for flat feet

(Image courtesy of In2Bones) Orthopedic surgical device developer In2Bones announced the global launch of its “see-through” PitStop implant for children and adults with flat feet. One of the most common foot deformities, flat-foot often starts during adolescence and continues into adulthood. In2Bones (Memphis, Tenn.) developed the PitStop subtalar implant to restore the stability of a patient’s […]

NuVasive wins expanded FDA nod for Monolith corpectomy system

NuVasive (NSDQ:NUVA) said yesterday that it won expanded FDA 510(k) clearance for its Monolith corpectomy system, now cleared for use in cervical corpectomy procedures. The system is now cleared for procedures in the cervical spine, between the C3-C7 vertebral bodies, to treat diseased or damaged vertebral body caused by fractures, tumors, osteomyelitis or to support reconstruction […]

Enhancing post-market safety

Ashton Steinhagen, lead clinical research associate for IMARC Research, Inc. The FDA released a follow-up statement to their “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health” release that was unveiled in April 2018.  The focus was expanding on post-market surveillance for medical devices. In this plan, the main objectives were to promote and […]

Feds drop insider trading, perjury charges against ex-AMO chief Mazzo

Federal prosecutors this week dropped perjury and insider trading charges against former Advanced Medical Optics CEO James Mazzo related to AMO’s $2.8 billion acquisition by Abbott (NYSE:ABT) in 2009 in light of two hung juries, according to court documents. Judge Andrew Guilford for the U.S. District Court for the Central District of California ordered a dismissal with prejudice for Mazzo this […]