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,...

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...

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...

Alphabet Inc.'s Verily Life Sciences LLC is set to receive $800 million in funding from Temasek, a Singapore-based investment company. A majority of the investment will be funded in the coming days, and the remainder will come in the second half of this year. In exchange for the funding, Temasek will receive a minority stake in the Mountain View, Calif.-based company, which was once Google's life sciences division. This will be the first time Verily has taken funding from an outside investor, said Carolyn Wang, a spokesperson for Verily. The company primarily derives its funding...

Heart Test Labs Inc. (HTL) has raised about $12 million in its most recent funding round. The company is developing Myovista, an electrocardiography device, that it said could potentially fill the "diagnostic gap" in heart disease. HTL is currently vying for approval of Myovista in Europe. "We're on the cusp of going to market [in Europe]," Andrew Simpson, executive chairman of Westlake, Texas-based HTL, told Medical Device Daily. "Fingers crossed, we expect to get CE mark approval this quarter. This round is going to be used to build up the sales capacity of the company...

Johnson & Johnson Corp. (J&J) forecast lower-than-expected 2017 sales but managed to beat Wall Street expectations for its 4Q16 earnings. In addition, the New Brunswick, N.J.-based company said it could potentially sell off its diabetes care businesses amid disappointing sales. Tuesday's news was mixed at best. While 4Q16 adjusted earnings per share of $1.58 exceeded analysts' consensus estimates of $1.56, J&J drew criticism for its soft 2017 guidance. The firm forecast 2017 adjusted earnings of $6.93 to $7.08 per share – below the average analyst estimate of $7.11 per share. Joshua Jennings, an analyst with...

The FDA final guidance for combination product good manufacturing practices (GMPs) grew by 10 pages compared to the draft guidance, but the final product was hailed as "a good guidance document" by Bradley Merrill Thompson of Epstein Becker & Green, the law firm that has represented the Combination Products Coalition on combo product regulatory matters before the FDA. The January 2015 draft guidance for combo product GMPs followed a similar document published in 2004, which the agency eventually withdrew. This was followed in 2013 by the final rule for combo product GMPs, an effort the...

Amedica Corp. is looking to raise $4.5 million through a public offering slated to close on Tuesday. The funding raise comes in the middle of the Salt Lake City-based company's bid to obtain clearance for its Valeo cancellous-structure ceramic cervical (C+Csc) implant. Amedica has been waiting for the FDA to green light the device for nearly two years now. (See Medical Device Daily, Feb. 13, 2015.) Amedica said it will use proceeds from the offering to fund research and development and commercialization activities of its product candidates, including the funding of clinical trials. It will...

Banyan Biomarkers Inc. is getting $7 million in funding from in vitro diagnostics specialist Biomérieux SA to help develop a blood test for traumatic brain injury (TBI). In addition, the Marcy L'etoile-France-based company has also obtained the right to commercialize Banyan's TBI tests with its Vidas immunoassays range platform. Banyan's test uses two brain specific protein biomarkers (Banyan UCH-L1 and Banyan GFAP) that rapidly appear in the blood after a brain injury. The San Diego-based company was founded in 2002 and is a spin off from the University of Florida. "We are excited about the...

PARIS – A month earlier than expected, Dublin-based Medtronic plc said it has received the CE mark for the Corevalve Evolut R 34 millimeter transcatheter aortic valve implantation (TAVI). The clearance for commercialization in the European Union follows approval by the U.S. FDA in October 2016, and rounds out the top end of the Medtronic TAVI portfolio that includes 23 millimeter, 26 millimeter and 29 millimeter valves. "We look forward to working with physicians across Europe to offer this highly anticipated valve size to the thousands of patients who were previously unable to receive TAVI...