Company Product Description Indication Status
Berlin Heart Inc., of The Woodlands, Texas Excor Pediatric Ventricular assist device For pediatric heart failure patients Completed its post approval surveillance study; the reported stroke rate of 11% and a mortality rate of 12.5% within this U.S. FDA-mandated surveillance fulfilled the primary objectives of the study, exceeding the prespecified performance goal; the safety and efficacy of the device fulfilled all other defined study endpoints
Osteolabs GmbH, of Kiel, Germany Osteotest Uses a simple urine or blood sample Early detection of bone loss A recent study of 100 women showed the Osteotest can predict fractures caused by bone atrophy better and noninvasively vs. the dual-energy X-ray absorptiometry method currently used
Pulse Biosciences Inc., of Hayward, Calif. Cellfx system Uses Nano-Pulse Stimulation (NPS) technology Treatment of cutaneous, non-genital warts Presented interim findings from a pivotal clinical study; 87 treated warts on 27 patients showed improved efficacy with respect to high clearance ratings and no recurrence at 60 days after the last NPS treatment; NPS technology was particularly effective in clearing warts on the knees, hands and legs; no smoke or vapor plume was reported in a subcohort of patient treatments, as confirmed by a particulate counter

Notes

For more information about individual companies and/or products, see Cortellis.

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