Elekta AB has received FDA clearance for its Venezia applicator for gynecological brachytherapy. The device is positioned to treat advanced-stage cervical cancer and has had a CE mark since last year. The Stockholm-based company said Venezia has a design that facilitates predefined and consistent needle placement to access difficult to reach tumors that extend outside of the cervix. Elekta said the use of interstitial brachytherapy in patients with tumors that extend outside of the cervix may be underutilized due to the limited reach of existing applicators and the complexity of precisely targeting tumor tissue. Data...

Elekta AB has received FDA clearance for its Venezia applicator for gynecological brachytherapy. The device is positioned to treat advanced-stage cervical cancer and has had a CE mark since last year.

Medtronic plc has won FDA clearance for its Cardioinsight noninvasive 3-D mapping system. The device, which has been approved in Europe for nearly five years, is used to improve the mapping of electrical disorders of the heart. The Dublin-based company first gained access to the device through its $93 million acquisition of Cleveland-based Cardioinsight Inc. (See Medical Device Daily, June 22, 2015.) The device could become a safer and less costly alternative to traditional cardiac mapping procedures, which are typically accomplished by inserting a catheter into the heart via an artery or vein. The Cardioinsight...

Medtronic plc has won FDA clearance for its Cardioinsight noninvasive 3-D mapping system. The device, which has been approved in Europe for nearly five years, is used to improve the mapping of electrical disorders of the heart. The Dublin-based company first gained access to the device through its $93 million acquisition of Cleveland-based Cardioinsight Inc. (See Medical Device Daily, June 22, 2015.)

Pro-Dex Inc. said it is selling its Oregon Micro Systems division to Beaverton, Ore.-based Oms Motion Inc. The Irvine, Calif.-based company's division designs embedded multiaxis motion controllers, which are sold to distributors or original equipment manufacturers in the automation and research industries. The transaction is about $640,000. Oms Motion Inc. is being headed up by Phillip Brown, who once served as manager of Pro-Dex's OMS division. "We are pleased that this sale was consummated so quickly, in part due to the knowledge that [Brown] has regarding the business and its prospects," said Richard Van Kirk,...

Pro-Dex Inc. said it is selling its Oregon Micro Systems division to Beaverton, Ore.-based Oms Motion Inc. The Irvine, Calif.-based company's division designs embedded multiaxis motion controllers, which are sold to distributors or original equipment manufacturers in the automation and research industries. The transaction is about $640,000.

Mallinckrodt plc has closed on a $690 million deal to sell its nuclear imaging business to St. Louis-based Iba Molecular Corp. The deal was first disclosed back in August of last year. The Staines-upon-Thames, U.K.-based company's imaging business produces the radioisotope molybdenum-99, from which technetium-99m is derived and is used in about 80 percent of all nuclear medicine procedures worldwide. "Our view of an announced sale of the Nuclear Imaging business for $690 million is positive even if the divestiture takes away [about] $415 million in sales," said David Buck, an analyst with Northland Capital...

Mallinckrodt plc has closed on a $690 million deal to sell its nuclear imaging business to St. Louis-based Iba Molecular Corp. The deal was first disclosed back in August of last year. The Staines-upon-Thames, U.K.-based company's imaging business produces the radioisotope molybdenum-99, from which technetium-99m is derived and is used in about 80 percent of all nuclear medicine procedures worldwide.

Avinger Inc. reported positive two-year clinical data from the pivotal VISION study of its Lumivascular technology. The VISION study was designed to evaluate the Redwood City, Calif.-based company's Pantheris system, which received FDA clearance last year. (See Medical Device Daily, March 10, 2016.) Interim results from 55 patients in the study were released at the Leipzig Interventional Course conference. Pantheris is used for directional atherectomy while allowing physicians to use real-time intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries. The study was used to further clarify the utility of...