Top Device Companies

Hologic To Get September FDA Review For 3-D Mammography Device

Hologic’s 3-D mammography system is set for review by the FDA in September, boosting the company’s hopes for a device it expects to be a big seller. An FDA meeting has been scheduled for Sept. 24 to review the Silenia Dimensions 3-D mammography system that offers a new way to screen for and diagnosis breast cancer. The announced schedule means Hologic could have its device on the market by the end of 2011. The device already is marketed in more than a dozen countries, including those in Europe and in the Middle East. (Click here for more – a subscription may be required)

“FDA Panel Sets Date To Review Hologic’s 3-D Mammography System” – Wall Street Journal (7/27/10)

Medical device manufacturers facing many challenges: from the rising clout of group purchasing organizations (GPOs) to payment bundling and physicians' growing allegiance with hospitals in product price negotiations. Get all the answers now in new Medtech Insight's new 24-page Special Report: Medical Device Landscape: How regulatory changes and cost control measures are reshaping the industry. Available for purchase now!

Hologic, Sentinelle Agree To $85 Million Merger Acquisition

Hologic and Sentinelle Medical of Canada have agreed to an $85 million buyout by the U.S. device maker seeking additional diagnostic tools for women. Sentinelle, a privately held company, supplies MRI breast coils, tables and visualization software. The merger agreement was expected to close by early fall, subject to certain financial conditions and Canadian approval. Sentinelle revenue last year was estimated at $15 million, equal to what Hologic earns from the U.S. military alone for its radiology devices. Terms of the acquisition were not disclosed. (Click here for more)

“Hologic Buying Sentinelle Medical For $85 Million” – MassHighTech (7/6/10)

Medical device manufacturers facing many challenges: from the rising clout of group purchasing organizations (GPOs) to payment bundling and physicians' growing allegiance with hospitals in product price negotiations. Get all the answers now in new Medtech Insight's new 24-page Special Report: Medical Device Landscape: How regulatory changes and cost control measures are reshaping the industry. Available for purchase now!

Hologic Gets $15 Million Contract To Supply Radiology Gear To Military

Hologic has been granted a $15 million contract by the U.S. Defense Department for its radiology systems and components over the next year. The contract comes in the wake of Hologic’s report of a first-quarter income loss of $26 million. The company recently settled a $12.5 million patent case with Ethicon Endo-Surgery, a unit of Johnson & Johnson. (Click here for more)

“Hologic Wins $15 Million Defense Dept. Contract” – Mass Device (4/8/10)

Medical device manufacturers facing many challenges: from the rising clout of group purchasing organizations (GPOs) to payment bundling and physicians' growing allegiance with hospitals in product price negotiations. Get all the answers now in new Medtech Insight's new 24-page Special Report: Medical Device Landscape: How regulatory changes and cost control measures are reshaping the industry. Available for purchase now!

Hologic Loses Patent Suit Against SenoRx Cancer Radiation Catheter

Hologic lost a suit against SenoRx when a federal court jury ruled Hologic’s patents related to its MammoSite for delivering radiation to tumors. The Hologic product was acquired last year when the company bought Cytyc, which filed the original suit. The SenoRx product at issue was its Contura catheter, which relies on radiation to break down cancerous tumors. (Click here for more)

“SenoRx Cleared In Patent Suit; Shares Rise” – Orange County Business Journal (12/18/09)

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Hologic Hit By Panel Advice To Halt Routine Breast Scans For Under 50

Hologic’s digital mammogram system is expected to take the brunt of a government panel’s recommendation that routine tests not be given to women below the age of 50. Previous guidelines called for regular mammograms for all women beginning at age 40. The U.S. Preventive Services Task Force said it changed its recommendation because of the frequency of false positives in women in their 40s. At the same time, the task force said it could not discern if there were benefits for giving the mammograms to women 75 and older. Hologic said the suggestion to drop them for women in their 40s is not supported by solid medical evidence. (Click here for more)

“Hologic Slips As Panel Recommends Fewer Mammograms” – AP (11/17/09)

JUST PUBLISHED: Medical Device Market 2009: Interventional Cardiology - Find out who’s going beyond catheters and drug-eluting stents in this vibrant space with this 86-page Special Report previously published in IN VIVO: The Business & Medicine Report. Order yours now!

Hologic Wins EU Approval For Cervical-Cancer Screening Device

Hologic’s device for screening for cervical cancer has European Union approval to market the ThinPrep integrated imager. The device combines the imaging technology in ThinPrep with slide review into a single unit. In addition to getting approval for the device in the EU, it also is approved for three of the four member states of the European Free Trade Association. (Click here for more)

“Hologic Device Is Approved By European Regulators” – Boston Globe (9/29/09)

Medical Device Manufacturers’ Employee Training Programs Are Under FDA Scrutiny -- Click Here To Find Out Why...

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Hologic Gets U.S. Military Contract To Supply $28 Million In Devices

Hologic has won a $28.2 million contract to supply medical devices to all of the forces of the U.S. military. Hologic specializes in diagnostics to detect cancer in women. The contract covers a five-year period for an unspecified amount of supplies valued at up to $28.2 million. Hologic was the sole bidder for the specified equipment. (Click here for more)

“Hologic Awarded $28 Million Military Supply” – Worcester Business Journal (9/22/09)

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Hologic Breast Cancer Radiation System Cleared By FDA

Hologic’s MammoSite ML radiation system has been cleared by the FDA for treating early-stage breast cancer. With the approval, Hologic said it expected to launch the system during the first quarter of fiscal 2010. The Hologic system helps radiation oncologists treat women not considered appropriate candidates for traditional brachytherapy. (Click here for more)

“Hologic’s Breast Cancer Treatment Gets FDA, OK, Shares Up” – Reuters (9/1/09)

Problems With Manufacturer Employee Training Programs Worry FDA. Click here to find out more...

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Hologic CEO Sees Fate In Coming Year Tied To Women Seeing Doctors

Hologic CEO Jack Cumming sees his company turning the corner in the diagnostic testing business as soon as women stop putting off medical visits because of the economy. He said women are putting off annual checkups and hospitals are delaying equipment purchases during the economic slowdown. Cumming said Hologic does not expect the current tight economy to ease to the point where capital equipment sales pick up again for at least another year. Hologic is attempting to cope by expanding its devices and diagnostics business to reduce its reliance on selling capital equipment. (Click here for more)

“Interview—Hologic CEO: Economic Recovery Will Be Slow” – Forbes (Reuters) (8/10/09)

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Smith & Nephew, Hologic Work On Less-Invasive Devices For Women

Smith & Nephew, Hologic and smaller device makers in the Boston area are engaged in research to make their surgery products less invasive for women. Smith & Nephew’s Endoscopy division based in the area is engaged in training physicians for the proper uses of its Operative Hysteroscopy System and other endoscopic devices to make the procedures less invasive. Hologic recently received FDA approval for its Adiana permanent contraception system that offers women a less-invasive alternative to tubal ligation. (Click here for more)

“Area Firms Aim To Make Women’s Surgery Less Invasive” – Mass High Tech (7/24/09)

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