Nipro (TYO: 8086) subsidiary Infraredx said today that it won expanded FDA 510(k) clearance for its Makoto intravascular imaging system, now cleared to identify patients and coronary plaques at an increased risk of major adverse cardiac events. The approval came based on results from the Lipid-Rich Plaque study in which researchers explored the ability of intravascular […]
Philips Medical Systems accuses ex-enginer of pilfering trade secrets
A former engineer at Philips Medical Systems in Illinois allegedly transferred confidential trade secrets and then tried to destroy the evidence, the company said in a lawsuit filed last week. The U.S. unit of Dutch healthcare conglomerate Royal Philips (NYSE:PHG) accused Jose Buan of downloading a large trove of proprietary, confidential information around the time […]
Aidoc raises $27m for medical image analysis software
Medical imaging tech developer Aidoc said this week that it raised $27 million in a Series B round of financing to support its artificial intelligence powered image analysis software. The round was led by Square Peg Capital and will be used to grow the Israel-based company’s tech and go-to-market team. “Our evaluation process included numerous […]
More device shortages pegged to sterilization plant shutdown
More medtech companies are experiencing shortages of medical devices due to the sudden closure in February of a Sterigenics sterilization plant. Officials from Cardinal Health (NYSE:CAH), and Guerbet (EPA:GBT) have written letters to customers indicating that certain devices are already in short supply or may experience shortages, Medical Device & Outsourcing has learned. The letter from Cardinal Health (Dublin, […]
Enlitic raises $15m in Series B
Artificial intelligence-enhanced medical diagnostics developer Enlitic said today that it closed a $15 million Series B round. Enlitic is designing a platform that uses AI to develop algorithms to identify and analyze suspicious findings in medical images. The company’s first product is designed to interpret chest x-rays to triage normal from abnormal scans, and to […]
Report: Researchers create CT, MRI image-altering malware to expose vulnerabilities
A group of researchers have created a malware program designed to exploit vulnerabilities in computed tomography and magnetic resonance imaging equipment to add realistic, malignant-seeming growths to scans in a bid to draw attention to vulnerabilities in medical equipment networks, according to a Washington Post report. Researchers Yisroel Mirsky, Yuval Elovici and two others at […]
Endra Life Sciences touts preliminary TAEUS liver fat analysis study data
Endra Life Sciences today reported preliminary results from the first-in-man feasibility study of its Thermo Acoustic Enhanced Ultrasound System exploring its ability to measure and analyze liver fat. The TAEUS platform is designed to allow for the visualization of human tissue composition, function and temperature at a cheaper cost than computed tomography or magnetic resonance […]
Volpara expands distro deal with GE Healthcare
Volpara Solutions said yesterday that it expanded its distribution agreement with GE Healthcare (NYSE:GE) to include the global distribution of its VolparaDensity software. Wellington, New Zealand-based Volpara said that its VolparaDensity software is designed to analyze mammograms using machine learning to provide automated, objective and volumetric breast density assessments and a breast density category that correlates […]
Philips buys Direct Radiology
Royal Philips (NYSE:PHG) said this week that it acquired teleradiology platform developer Direct Radiology for an undisclosed amount. The Amsterdam-based company said that with the acquisition it will be expanding into the teleradiology services field, looking to build on its cloud-based radiology informatics portfolio. New features slated to be added include teleradiology viewing and reporting capabilities, […]
Analogic escapes Labor Dept. suit over alleged pay discrimination
A U.S. Labor Dept. judge last week dismissed a suit the agency brought against Analogic over alleged pay discrimination. The Labor Dept. sued Analogic in October 2016, alleging that it paid female assembly workers at its Peabody, Mass., headquarters less than their male counterparts after a compliance review by its Office of Federal Contract Compliance Programs. […]
FDA wants to update mammography standards
The FDA today issued a proposed rule that would modernize mammography quality standards and require mammography facilities to provide more information to patients and healthcare providers. The proposed rule would be the first update in 20 years, amending regulations issued under the Mammography Quality Standards Act of 1992, which authorizes FDA oversight over mammography facilities, […]
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