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 […]
Artificial intelligence could prevent breast cancer false positives: Here’s how
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 […]
This LED-based device predicts radiation skin damage
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 […]
For AirXpanders, a switch from 510(k) to de novo was no big deal
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 […]
GE Capital backs Cianna Medical in $8m round
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 […]
AirXpanders raises $28.3m in Aussie IPO
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. […]
Lumicell receives FDA nod 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.
Danaher’s Leica division closes Devicor Medical buy
Medicare OKs reimbursement codes for 3D mammography
Danaher’s Leica division to buy Devicor Medical Products
Breast cancer: GE Healthcare wins pivotal FDA approval for 3D breast imaging
Imaging giant GE Healthcare (NYSE:GE) won FDA approval for its 3D breast tomosynthesis imaging system, MassDevice.com has learned.
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