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Hologic Inc (HOLX.OQ)

HOLX.OQ on NASDAQ Stock Exchange Global Select Market

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15 Dec 2017
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Latest Key Developments (Source: Significant Developments)

Third Respiratory Assay now FDA cleared on Hologic's new Panther Fusion system
Wednesday, 6 Dec 2017 

Dec 6 (Reuters) - Hologic Inc ::THIRD RESPIRATORY ASSAY NOW FDA CLEARED ON HOLOGIC'S NEW PANTHER FUSION® SYSTEM.HOLOGIC INC - ‍RECEIVED 510(K) CLEARANCE FROM FDA FOR PANTHER FUSION ADV/HMPV/RV ASSAY, A MULTIPLEXED ASSAY THAT RUNS ON NEW PANTHER FUSION SYSTEM​.  Full Article

HOLOGIC RECEIVES FDA 510(K) CLEARANCE OF QUANTRA 2.2 BREAST DENSITY ASSESSMENT SOFTWARE
Friday, 24 Nov 2017 

Nov 24 (Reuters) - Hologic Inc ::HOLOGIC RECEIVES FDA 510(K) CLEARANCE OF QUANTRA 2.2 BREAST DENSITY ASSESSMENT SOFTWARE.HOLOGIC INC- ‍HAS RECEIVED 510(K) CLEARANCE FROM U.S. FOOD AND DRUG ADMINISTRATION FOR QUANTRA 2.2 BREAST DENSITY ASSESSMENT SOFTWARE​.  Full Article

Hologic announces Q4 GAAP earnings per share $0.29
Wednesday, 8 Nov 2017 

Nov 8 (Reuters) - Hologic Inc ::Hologic announces financial results for fourth quarter of fiscal 2017.Q4 non-GAAP earnings per share $0.50.Q4 GAAP earnings per share $0.29.Q4 earnings per share view $0.49 -- Thomson Reuters I/B/E/S.Q4 revenue $802.9 million versus I/B/E/S view $792.5 million.Hologic Inc - ‍expect to post solid, mid-single-digit organic revenue growth in fiscal 2018​.  Full Article

Hologic - ‍received 510(k) clearance from FDA for Panther Fusion Paraflu assay​
Thursday, 26 Oct 2017 

Oct 26 (Reuters) - Hologic Inc :Hologic Inc - ‍received 510(k) clearance from FDA for Panther Fusion Paraflu assay​.  Full Article

FDA grants PMA approval for Hologic's Aptima hepatitis C Quant DX Assay
Wednesday, 15 Feb 2017 

Hologic Inc :FDA grants PMA approval for Hologic's Aptima hepatitis C Quant DX Assay.  Full Article

U.S. HHS awards $4.1 mln to Hologic to develop better Zika blood screening test
Tuesday, 9 Aug 2016 

U.S. Department of Health and Human Services: Awards $4.1 million to Hologic Inc to develop better Zika blood screening test . Under the one-year agreement, Hologic will advance the development of its Procleix Zika virus assay . Contract with Hologic could be extended up to 18 months and $6.2 million to support the clinical study Further company coverage: [HOLX.O] ((Bangalore.newsroom@thomsonreuters.com;)).  Full Article

Bovie Medical announces deal with Hologic Inc
Thursday, 21 Jul 2016 

Bovie Medical Corp : Bovie medical announces sales channel partnership agreement with hologic for J-Plasma® . Initial six-month agreement provides certain members of Hologic's direct gyn surgical sales force with access to J-Plasma(Reg) .Hologic will add Co's product line to healthcare solutions portfolio in gynecological gynecological/oncological surgery in 3 U.S. Regions.  Full Article

Hologic, Grifols say FDA approves Zika diagnostic test
Monday, 20 Jun 2016 

Hologic , Grifols : FDA has approved use of Procleix Zika virus blood screening assay on Procleix panther system under agency's investigational new drug study protocol .FDA approves use of the Procleix zika virus assay from Hologic and Grifols to screen the US blood supply under an IND study protocol.  Full Article

FDA grants emergency use authorization for Hologic's Aptima zika virus assay
Friday, 17 Jun 2016 

Hologic Inc: FDA grants emergency use authorization for Hologic's Aptima® zika virus assay . Aptima zika virus assay has not been FDA cleared or approved and is only authorized for use for duration of declaration that circumstances exist justifying authorization of emergency use . New diagnostic test for detection of zika virus now available for use on fully automated panther system .Aptima zika virus assay will be available for use in all 50 states, Puerto Rico and U.S. Territories.  Full Article

Hologic Inc gives Q2 2016 guidance; updates FY 2016 guidance
Wednesday, 27 Jan 2016 

Hologic Inc:Sees q2 2016, revenues $680 to $690 million.Sees q2 2016, non-gaap eps $0.45 to $0.46.Sees FY 2016 NON-GAAP EPS $1.86 TO $1.90.Sees FY 2016 revenue $2,800 mln to $2,830 mln.  Full Article

BRIEF-Third Respiratory Assay now FDA cleared on Hologic's new Panther Fusion system

* THIRD RESPIRATORY ASSAY NOW FDA CLEARED ON HOLOGIC'S NEW PANTHER FUSION® SYSTEM