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Breast Cancer

Ibex AI-enabled breast cancer diagnostic lands CE mark

May 26, 2021 By Sean Whooley

Ibex Medical Analytics announced today that it received CE mark approval for its Galen AI-based breast cancer diagnostic platform. Tel Aviv, Israel–based Ibex’s Galen platform uses AI and machine learning technology based on hundreds of thousands of image samples scanned from biopsy slides through digital pathology, according to a news release. Galen previously won CE […]

Filed Under: Diagnostics, Featured, Health Technology, Imaging, Mammography, Oncology, Regulatory/Compliance, Software / IT, Women's Health Tagged With: Breast Cancer, CE Mark, Ibex Medical Analytics

This imaging device could be a breast cancer treatment breakthrough

May 14, 2021 By Nancy Crotti

OncoRes Medical’s system may detect cancer cells on a microscopic scale during a lumpectomy, potentially averting the need for a second breast cancer surgery. Having breast surgery to remove a cancerous lump is traumatic enough. Learning that you’ll need another operation to remove cancer cells that the surgeon couldn’t detect the first time only adds […]

Filed Under: Business/Financial News, Diagnostics, Featured, Imaging, Oncology, Surgical, Women's Health Tagged With: Brandon Capital Partners, Breast Cancer, Breast Cancer Diagnostic, FDA, Medtech Innovator, OncoRes Medical

Could an algorithm improve breast cancer treatment?

December 20, 2019 By Sean Whooley

A study from researchers at Penn Medicine revealed that MRI and an algorithm-based field of medicine called radiomics could help characterize the heterogeneity of cancer cells in a tumor and allow for better understanding of the causes and progression of individual diseases. The study, published in Clinical Cancer Research, examines radiomics, which uses algorithms to extract […]

Filed Under: Clinical Trials, Featured, Imaging, Mammography, Oncology, Radiosurgery/Radiation therapy, Women's Health Tagged With: Breast Cancer, University of Pennsylvania

FDA ramps up scrutiny of materials in medical devices

March 15, 2019 By Nancy Crotti

The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances. It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts […]

Filed Under: 510(k), Cardiovascular, Featured, Food & Drug Administration (FDA), Implants, Materials Testing, Metal-on-Metal, News Well, Oncology, Orthopedics, Regulatory/Compliance, Replacement Heart Valves, Stents, Surgical, Women's Health Tagged With: animalmaterials, Bayer, Breast Cancer, breast implants, FDA, internationalconsortiumofinvestigativejournalists, metal-on-metal hips, Netflix, nitinol

Artificial intelligence could prevent breast cancer false positives: Here’s how

October 19, 2017 By Danielle Kirsh

Artificial intelligence could improve detection and diagnosis of breast cancer and eliminate false positives, according to new research out of the Massachusetts Institute of Technology’s Computer Science and Artificial Intelligence Laboratory (CSAIL). A team of researchers from MIT’s CSAIL, Massachusetts General Hospital and Harvard Medical School developed an AI system with machine learning that can […]

Filed Under: Oncology, Research & Development, Women's Health Tagged With: artificial intelligence, Breast Cancer, Harvard Medical School, Massachusetts General Hospital, Massachusetts Institute of Technology, MedTech

This LED-based device predicts radiation skin damage

March 29, 2017 By Chris Newmarker

Researchers at UC Irvine’s Beckman Laser Institute are developing imaging to predict the skin damage that breast cancer patients will experience from radiation treatment, The Optical Society reported today. “We use visible and near-infrared light at very low power and project it onto the breast. We are trying to characterize the skin damage during radiation […]

Filed Under: Imaging, News Well, Research & Development Tagged With: Beckman Laser Institute, Breast Cancer, Cancer, UC Irvine

For AirXpanders, a switch from 510(k) to de novo was no big deal

December 21, 2015 By Mark Hollmer

Scott Dodson didn’t worry when the FDA requested a call. Dodson is CEO of AirXpanders, a Palo Alto, Calif.-based company that had made a 510(k) submission for its AeroForm tissue expander, a device designed for post-mastectomy breast reconstructions that uses a gradual patient-controlled release of compressed gas to expand and stretch the skin/underlying muscle before […]

Filed Under: Women's Health Tagged With: AirXpanders, Breast Cancer, MassDevice Q&A

GE Capital backs Cianna Medical in $8m round

July 16, 2015 By Brad Perriello

Cianna Medical said today that it raised $8 million for its Savi Scout breast cancer device, including a $4 million debt round from GE Capital and another $4 million equity round from existing backers. Aliso Viejo, Calif.-based Cianna’s Savi Scout is designed to produce audible and visual indicators surgeons can use to tag cancerous tissue during lumpectomy […]

Filed Under: Funding Roundup, Surgical, Women's Health Tagged With: Breast Cancer, Cianna Medical

AirXpanders raises $28.3m in Aussie IPO

June 19, 2015 By Fink Densford

Breast tissue expansion device maker AirXpanders said yesterday that it raised $28.3 million (A$36.5 million) in an oversubscribed initial public offering. Palo Alto, Calif.-based AirXpanders said it floated 73 million shares at 39¢ (A50¢) apiece, with an indicated full-diluted market capitalization of $87.7 million (A$113 million). “We are delighted with the strong response to this IPO. […]

Filed Under: Business/Financial News, Women's Health Tagged With: AirXpanders, Breast Cancer

Lumicell receives FDA nod for feasibility trial

May 22, 2015 By Fink Densford

Lumicell receives nod from FDA for feasibility trial

Lumicell Diagnostics said it won an investigational device exemption from the FDA for a pilot feasibility trial of its imaging system for breast cancer surgeries.

The study is slated to be conducted at the Mass. General Hospital in Boston, the company said.

Filed Under: News Well, Surgical Tagged With: Breast Cancer, Lumicell

Danaher’s Leica division closes Devicor Medical buy

December 4, 2014 By Brad Perriello Leave a Comment

Danaher's Leica division closes Devicor Medical buy

Filed Under: Mergers & Acquisitions, News Well Tagged With: Breast Cancer, Danaher Corp., Devicor Medical Products, Leica Biosystems

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