Entries by CAPTIS

Acelity’s KCI launches Abthera NPWT system in Japan

Acelity subsidiary KCI said today that it launched its Abthera open abdomen negative pressure therapy system in Japan. The San Antonio-based company’s Abthera is a temporary abdominal closure system intended to allow surgeons to manage challenging abdominal wall openings where primary closure is not possible and to manage repeat abdominal entries. KCI said that the system has […]

ARS Pharmaceuticals wins fast track status for epinephrine nasal spray

ARS Pharmaceuticals said this week that it won fast track status from the FDA for its investigational intranasal epinephrine spray, ARS-1. The San Diego, Calif.-based company’s device is designed to be an easy-to-use treatment for people suffering from severe allergic reactions to food, drugs and insect bites. Get the full story at our sister site, Drug […]

Mauna Kea, Cook Medical terminate Cellvizio dev, distro deal

Mauna Kea (ENT:MKEA) said today that it and Cook Medical have mutually decided to terminate their development and distribution agreement. The deal, originally inked in late 2015, included the development of Mauna Kea’s Cellvizio confocal laser endomicroscopy systems for urologic applications. Paris-based Mauna Kea said that it agreed to develop a private-label version of the Cellvizio […]

Axonics Modulation touts results of sacral neuromodulation study

Axonics Modulation Technologies (NSDQ:AXNX) announced positive top-line results from a pivotal study of its novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction. The clinical study demonstrated that patients implanted with the Axonics r-SNM system experienced clinically meaningful and statistically significant improvements in urinary urgency incontinence (UUI) symptoms and quality of […]

CorMatrix launches FDA IDE Cor Tricuspid ECM cardiac valve trial

CorMatrix Cardiovascular said today that it launched a trial of its Cor Tricuspid ECM cardiac valve intended for treating adults with endocarditis and pediatric patients with congenital heart valve disease, adding that the first patient in the trial has already been treated. The first procedure in the trial took place at the Francicscan Health Heart Center […]

Philips wins FDA nod for DigitalDiagnost C90 digital radiography system

Philips (NYSE:PHG) said yesterday that it won FDA 510(k) clearance for its DigitalDiagnost C90 digital radiography system. The Amsterdam-based company said that the DigitalDiagnost C90 includes a live camera image displayed directly at the tube head to provide a clear view of the anatomical area being scanned during positioning. The newly cleared system also incorporates Philips […]

Teleflex shares droop on Q4, 2018 earnings release, restructuring announcement

Shares in Teleflex (NYSE:TFX) have fallen today after the medical device maker released fourth quarter and full year 2018 earnings mostly in line with analysts expectations, as well as a 3-year, $56 million restructuring plan. The Wayne, Penn.-based company posted profits of approximately $90.6 million, or $1.93 per share, on sales of $641.6 million for the […]

Report: Medtronic to close Portsmouth, N.H. transformative solutions facility

Medtronic (NYSE:MDT) said this week that it plans to close its Portsmouth, N.H.-based transformative solutions facility within the year, according to a Portsmouth Herald report. The Fridley, Minn.-based company recently informed employees at the facilities that it planned to eliminate its Portsmouth jobs, according to the report. The facilities currently employ 150 individuals. Medtronic spokesperson Brett Cromwell […]

Late mortality rates ‘inadvertently reversed’ in 5-year study of paclitaxel-eluting stent

The journal Circulation said this week that the all-cause mortality rates in a study comparing a paclitaxel stent and percutaneous transluminal angioplasty in people with peripheral artery disease were “inadvertently reversed” by the authors. In the first version of the paper, originally published in 2016, researchers reported that the 5-year all-cause mortality rate for people treated with Cook […]

NuVasive shares rise on Q4, 2018 EPS beat

Shares in NuVasive Inc. (NSDQ:NUVA) have risen slightly today after the medical device maker beat earnings per share expectations on Wall Street with its fourth quarter and full year 2018 earnings report. The San Diego-based company posted profits of approximately $12.2 million, or 23¢ per share, on sales of $288.3 million for the three months ended […]