The FDA’s Center for Devices and Radiological Health (CDRH) released its latest top 10 regulatory science priorities yesterday. They are: Use Big Data to aid in regulatory decision-making. Modernize biocompatibility and biological risk evaluation of device materials. Use real-world evidence and evidence synthesis across multiple domains in regulatory decision-making. Advance tests and methods for predicting […]
Former FDA commissioners want more funding for real-world evidence
Three former FDA commissioners are calling on Congress to fully fund the agency’s $60 million fiscal year 2020 budget for using more real-world evidence to evaluate drugs, biologics and devices. Most of that money — $23 million — is earmarked for medical devices. The document is titled “Expanding the Use of RealWorld Evidence in Regulatory […]
Ultrasound firm Terason partners with DiA Imaging Analysis
Ultrasound imaging company Terason said today that it has inked a deal with y DiA Imaging Analysis to provide DiA Imaging’s cardiac solutions on Terason’s point-of-care ultrasound devices. The partnership fills a market need for more accurate and objective image analysis for clinicians in hospitals and outpatient settings, that commonly analyze ultrasound images visually, according […]
GE Healthcare enters AI-powered aneurysm research effort
GE Healthcare (NYSE:GE) has joined a research collaboration with Fujitsu Australia and an Australian university and imaging clinic to diagnose and monitor brain aneurysms on scans faster and more efficiently using artificial intelligence (AI). The project with Macquarie University and Macquarie Medical Imaging today landed a $1.4 million grant from the Australian government. Fujitsu will […]
Nanowear to launch trial of heart failure-monitoring underwear
Nanowear said today that it has launched a heart failure management and alert diagnostic validation study of its medical-grade, cloth-based nanosensor technology. The SimpleSense undergarment has a closed-loop machine learning platform designed to capture and algorithmically score phonocardiography, impedance cardiography measuring stroke volume and cardiac output, and multi-channel ECG assessing heart rate and heart rate […]
Paige touts study that validates its cancer diagnosis AI
AI-aided pathology company Paige said today that a new study has found that its computational decision-support systems can help clinicians diagnose and treat cancer. Published in Nature Medicine, a paper on the study describes an AI system for computational pathology that achieves clinical-grade accuracy levels. Researchers developed deep-learning algorithms to build a system that can detect prostate cancer, skin cancer […]
Quarterly M&A is in the billions in Minnesota’s Medical Alley
Mergers and acquisitions neared $15 billion among Medical Alley Association members in the second quarter of 2019, the Minnesota trade group said today. About half of that was generated by one company — Minnetonka-based UnitedHealth Group (NYSE:UNH), which completed its long-awaited $4.3 billion acquisition of DaVita Healthcare (NYSE:DVA) in June. United also acquired two other companies in the […]
iCad’s AI-assisted mammography tech wins CE Mark
iCad (NSDQ:ICAD) has won the CE Mark for its advanced artificial intelligence technology and workflow solution, ProFound AI for 2D mammography. The Nashua, N.H.-based cancer detection and radiation therapy devices maker developed the technology to boost breast cancer detection by identifying soft-tissue densities and calcifications. ProFound AI for 2D mammography is the latest addition to […]
ADA 2019: Hybrid closed-loop devices take center stage
The American Diabetes Association’s 79th Scientific Sessions is a five-day conference where researchers and healthcare professionals share the latest in diabetes research. More than 180 sessions and over 2,000 research presentations took place during the meeting on June 7-11 in San Francisco. During the meeting, diabetes experts shared data and research from clinical trials. Here are four […]
Philips touts Stellarex drug-coated balloon data
Patients using Royal Philips’s (NYSE:PHG) Stellarex drug-coated balloon maintained blood flow through the treated segment of diseased arteries at three years in a pair of clinical trials. Stellarex is designed to restore and maintain blood flow in the superficial femoral artery and peripheral arteries. It’s coated using the company’s EnduraCoat technology to elute the drug paclitaxel. Spectranetics won […]
5 digital health startups you need to watch in 2019
Funding for digital health companies continues to rise, with 2018 the biggest year so far this decade, according to healthcare investment firm StartUp Health. Investors took a greater interest in machine learning, blockchain and artificial intelligence (AI). Digital health funding was 14 times greater than it was eight years ago, when New York-based StartUp Health began […]
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