Conformis Inc. said it withdrew its application to the FDA for a 510(k) the Itotal Hip implant due to the agency raising a number of questions about the product. The Bedford, Mass-based company said it was not able to address all the questions within the allowed review timeline and plans to submit a new application in the second half of this year. The company originally submitted an application for 510(k) clearance of Itotal Hip in the second half of last year. News of the withdrawal caused shares of Conformis (NASDAQ:CFMS) to take a tumble, trading down as much as 9.6 percent on Monday.
Saluggia, Italy-based, Diasorin S.p.A. said it will acquire Focus Diagnostics Inc.'s immunodiagnostic and molecular diagnostic products for $300 million in cash from Madison, N.J.-based, Quest Diagnostics Inc.
Affymetrix Inc's board has rejected a $1.5 billion bid to derail a plan that would have Waltham, Mass.-based Thermo Fisher Scientific Inc. acquire it for $1.3 billion. Origin Technologies Corp. revealed the 11th hour plan to acquire the Palo Alto, Calif.-based company late last week (Medical Device Daily, March, 21, 2016).
