MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Home » Hologic lands CE Mark for cervical cancer device

Hologic lands CE Mark for cervical cancer device

By

Hologic Inc. won CE Mark approval in the European Union for its ThinPrep integrated imager for cervical cancer.

The Bedford, Mass.-based women’s health products maker said the approval clears the way for it to bring the device to market in the EU’s 27 member countries, plus the three European Free Trade Assn. members and other nations that recognize the mark.

The ThinPrep device integrates imaging technology and slide review into a single device. It works by analyzing a Pap smear slide, scanning each cell or cell cluster and flagging “diagnostically relevant” cells or cell groups, according to a press release.

A cytologist then checks the flagged areas for abnormalities; if none are evident the slide is deemed negative, but if abnormalities are detected it can be forwarded through the lab’s quality control process. As an added bonus, the imager can be used as a conventional microscope.

The Food & Drug Administration has not cleared ThinPrep integrated imager for sale in the U.S., but Hologic’s director of corporate communications Jeff Keene told MassDevice that the company is determining the best approach to gain FDA approval.

Hologic posted $41 million in third-quarter net income on $403 million in sales, a 32 percent drop from the $61 million the company reported on $430 million in sales during the same period last year.

In case you missed it

RSS From Medical Design & Outsourcing

  • Thermo Fisher Scientific ticks up on Street-beating Q3 results
    Thermo Fisher Scientific (NYSE:TMO) today posted third-quarter results that beat the overall consensus on Wall Street. The Waltham, Massachusetts-based laboratory supply company reported profits of $1.9 billion, or $4.79 per share, on sales of $9.3 billion for the three months ended October 2, for a bottom-line loss of -1.6% on sales growth of 9.49% compared with… […]
  • Emerson introduces new miniature rocker isolation valve for clinical lab instruments
    Emerson (NYSE:EMR) has launched the ASCO Series 062 rocker isolation valve, designed for hematology and immunoassay analyzers, sample preparation and pre-analytical, as well as DNA sequencing instruments. The St. Louis, Missouri-based company said the two-way and three-way valves are compact at 16mm, allowing for easy integration into complex fluid-handling manifolds while reducing their footprint, weight… […]
  • Medtronic faces longer road to renal denervation
    Medtronic (NYSE:MDT) will continue the clinical study of its Symplicity Spyral renal denervation (RDN) system for hypertension into next year after lacking the positive results needed to end enrollment early. Fridley, Minnesota-based Medtronic said last month that it hoped to present results of the Spyral HTN-ON MED trial at the Cardiovascular Research Foundation’s TCT Conference… […]
  • Cadence is expanding in Pennsylvania
    Cadence (Staunton, Virginia) announced today that it is expanding its Product Realization Center in Cranberry Township, Pennsylvania. The company expects to finish the 21,000-square-foot expansion by March 2022. The expanded manufacturing footprint will include an additional Class 7 (10,000) cleanroom by the end of 2022. “Everything lined up so well for this expansion to take… […]
  • 3M beats The Street in Q3 as healthcare sales increase year-over-year
    3M (NYSE:MMM) shares rose slightly today on third-quarter results that topped the consensus forecast. The Maplewood, Minnesota-based company posted profits of $1.4 billion, or $2.45 per share, on sales of $8.9 billion for the three months ended Sept. 30, 2021, for a 0.3% bottom-line gain on sales growth of 7.1%. Earnings per share registering at… […]
  • Powering MRIs: 3 RF interconnect considerations to save time and money
    RF interconnects, including coaxial cables and connectors, are an integral part of MRI systems. Early awareness of challenges such as transmission loss, ease of installation and infrastructure requirements can help with performance and cost optimization in the design of new MRI systems. Kai Loh, Times Microwave Systems Magnetic resonance imaging (MRI) technology has advanced rapidly… […]
  • European approval ‘a big deal’ as Medtronic moves forward with Hugo surgical robot
    There’s excitement at Medtronic after the Hugo robotic surgery platform hit a major regulatory milestone. In 2012, Covidien formed an incubator called “Project Einstein,” focusing on combining robotic technology, data and analytics. What could they create? About nine years later, the product that emerged from Project Einstein made a significant step forward when the Hugo robotic-assisted… […]
  • Orchid announces hiring of chief quality, regulatory and EH&S officer
    Orchid (Holt, Michigan) announced that Lourdes De Cardenas Alfonso has joined the company as chief quality, regulatory and EH&S officer — effective today. Lourdes joins the orthopedic implants outsourcer from Medical Card System (MCS), where she was EVP of innovation. She has over 30 years of experience in quality control, regulatory affairs, technical services, business… […]
  • Nitto Kohki introduces vacuum pump for pick-and-place applications
    Nitto Kohki USA today announced the introduction of a standalone vacuum pump device that it says is ideal for pick-and-place applications, The LV-125A (Linicon) vacuum pump is particularly useful when house air is not available, according to the company. The pump is compact, lightweight, and features an oil-less design so that it can easily fit… […]
  • October 2021 Issue: Women in Medtech
       How Hologic made a major pandemic pivot: CFO Karleen Oberton reflects on key decisions and turning points of the COVID-19 pandemic. Insulet CEO Shacey Petrovic is pumped up to launch Omnipod 5 Boston Scientific’s Meghan Scanlon forecasts the future of urology There is still a long way to go to close the gender… […]
  • Study finds single-use bronchoscopes reduce hospital readmission rates by half
    A study of 14,228 bronchoscopy procedures found sterile, disposable scopes reduced readmission rates by more than half. The study, authored by Ambu consultant Dr. Hudson Garrett, analyzed procedures at inpatient hospitals as well as outpatient ambulatory facilities. He found that 3.6 percent of patients treated with a single-use, flexible bronchoscope were readmitted within 30 days,… […]

Leave a Reply