Shares of Optos plc (LSE:OPTS) gained 6.4 percent after the company announced that the FDA granted 510(k) clearance in the U.S. for its Project Daytona retinal scanning device.
The British ophthalmology device maker’s stock closed at £1.62 today (about $2.64), up about 15 cents since August 25, the day before the clearance announcement, when OPTS shares closed at £1.52 ($2.49) on the London Stock Exchange.
“Optos is now in preparation for full product launch on schedule in the first calendar quarter of 2012,” according to a press release.
The system is billed as a “next-generation ultra-wide-field retinal scanning device,” designed to deliver higher-quality images of the human retina.
“FDA approval for Daytona is an important step towards commercial launch. We plan to unveil details of the product at the American Academy of Optometry in October and to commence product shipments early next year,” CEO Roy Davis said in prepared remarks. “We believe that Daytona will allow us to globalize our core imaging technology, enabling us to penetrate new geographic markets and expand our presence in existing markets.”
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nContact wins CE Mark for ablation device
nContact Inc. won CE Mark approval in the European Union for its Epi-Sense guided coagulation device for cardiac arrhythmias.
The system uses epicardial sensing electrodes so that physicians can map and navigate the epicardium – the outer layer of heart muscle – and identify areas for ablation.
nContact said it plans to have the device on the market in Europe during the fourth quarter; Epi-Sense hasn’t yet won a nod from the FDA.
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Biotronik’s Selectra lead wins CE Marking
Biotronik won CE Mark approval in the European Union for its Selectra left ventricular lead delivery system.
The German med-tech giant touts the system as “the first telescopic delivery system for direct delivery of low-profile left ventricular leads to incorporate a slittable hemostatic valve.”
The company is likely hoping for similar good news in the U.S., which could help eclipse a scandal in Nevada over its alleged chicanery. In April, a New York Times probe turned up a Las Vegas hospital’s allegedly purchased preference for the company’s pacemakers and defibrillators.
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Toshiba’s Kalare imaging system wins 510(K) clearance
Toshiba Corp.’s (TYO:6502) American medical device operation won 510(k) clearance from the Food & Drug Administration for its Kalare HDR-08A imaging system.
The Japanese firm, which has a sizable presence in the international medical device market, hawks the new system as offering a more intuitive user interface and advanced image processing, “increasing the dynamic range of fluoroscopy,” according to a press release.
“The HDR-08A Imaging System for Kalare exemplifies how Toshiba continues to improve and develop technology to meet the needs of facilities looking to increase patient throughput,” X-ray vascular unit director Stephen Bumb said in prepared remarks. “With an improved user interface and increased dynamic range, more exams can be performed with increased diagnostic confidence.”
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Vexim wins CE Mark for new SpineJack implant size
Vexim won a CE Mark of its 6.5mm SpineJack implant, saying it already has the device on the market across the pond.
“We are delighted to have obtained the CE Mark for our 6.5mm implant; it constitutes an essential milestone for rolling out our pre-sales strategy in Europe with a range of target populations,” Vexim CEO Bruce de la Grange said in prepared remarks. “The CE Mark guarantees that our technology has the levels of reliability and safety that our customers demand and expect from us.”
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Mauna Kea wins 510(k) for Cellvizio 100 endomicroscopy device
Mauna Kea Technologies (EPA:MKEA)won 510(k) clearance for its endomicroscopy system Cellvizio 100.
The system, which is designed to give doctors real-time microscopic images of the gastrointestinal and pulmonary tracts, won a CE Mark in April, according to a press release.
“Based on the feedback from our current user base, we have made significant improvements to help physicians integrate Cellvizio into their endoscopy suites,” founder and CEO Sacha Loiseau said in prepared remarks. “As announced during our initial public offering in July 2011, this market release is a major milestone and achievement for us and demonstrates our continued commitment to innovation in the endomicroscopy market.”
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Masimo touts regulatory wins in Japan, Canada
Masimo (NSDQ:MASI) pulled down regulatory clearances in Japan and Canada for its Pronto-7 noninvasive hemoglobin test.
The company said the Japanese Ministry of Health Labor & Welfare and Health Canada each gave the nod to the device, which “provides immediate real-time hemoglobin results that enable clinicians to more rapidly assess patients and detect and treat internal bleeding and low hemoglobin conditions earlier,” according to a press release.
The needle-less system measures total hemoglobin, SpO2, perfusion index and pulse rate in less than a minute, according to the release.
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AirXpanders wins IDE for pneumatic breast cancer reconstruction aid
AirXpanders of Palo Alto won an investigational device exemption from the FDA for its AeroForm tissue expander for breast cancer reconstruction procedures.
As reported by MedGadget.com, the device employs compressed carbon dioxide to fill the expander, which is used to create a sufficient pocket in the pectoral mound to receive a breast implant after mastectomy. The system allows the patient to implement the expansion process using a remote control.
“During the company’s feasibility trial in Australia, the average expansion time associated with the AeroForm remote-controlled tissue expander was 15 days, a fraction of the time typically required using traditional saline expanders,” the blog reported.
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