An investigation on behalf of investors of Hologic, Inc. (NASDAQ: HOLX) shares over potential securities laws violations by Hologic, Inc. and certain of its directors and officers in connection with certain financial statements was announced.

The investigation by a law firm focuses on possible claims on behalf of purchasers of the securities of Hologic, Inc. (NASDAQ: HOLX) concerning whether a series of statements by Hologic, Inc. regarding its business, its prospects and its operations were materially false and misleading at the time they were made.

Marlborough, MA based Hologic, Inc. develops, manufactures, and supplies diagnostics products, medical imaging systems, and surgical products for women in the United States, Europe, the Asia-Pacific, and internationally. Hologic, Inc. reported that its Total Revenue rose from over $2.83 billion for the 12 months period that ended on September 24, 2016 to over $3.05 billion for the 12 months period that ended on September 30, 2017 and that its Net Income for those respective time periods increased from $330.8 million to $755.5 million.

On July 30, 2018, the U.S. Food and Drug Administration (FDA) issued a statement warning against the use of 'energy-based devices' to perform vaginal 'rejuvenation' and/or cosmetic vaginal procedures and stated it was aware of certain manufacturers inappropriately marketing energy-based devices. The FDA further disclosed it had sent a letter to Cynosure notifying the Company that marketing for its MonaLisa Touch may violate the Federal Food, Drug, and Cosmetic Act. Then on August 13, 2018, Hologic filed an 8-K stating that 'Although the FDA did not mention Vitalia in its recent comments or the [MonaLisa Touch] MLT Letter, Cynosure has carefully considered the FDA's broader concerns and elected to suspend marketing and distribution of Vitalia handpieces and single-use probes until it has confirmed they meet all regulatory requirements for devices in this category. Cynosure is also asking customers to return any Vitalia handpieces and unused probes they have purchased.'