Paige.AI's prostate cancer detection tech to be offered by Philips | Leo Pharma to develop needle-free drug delivery system with Portal | Funding round brings in $50M for Akoya
December 6, 2019
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Paige.AI's prostate cancer detection tech to be offered by Philips
Startup Paige.AI's Paige Prostate cancer detection technology will be offered by Philips to European pathology laboratories next year. The AI-based module was granted FDA breakthrough device status earlier this year.
MedTech Dive (12/5) 
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The Future of Risk Management in Medical Device
New eBook: A comprehensive guide to moving from corrective to predictive risk management. Learn how to improve risk management - regardless of PLM maturity, and how to leverage machine learning and advanced analytics to analyze risk and quality data
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Business & Market Trends
Leo Pharma to develop needle-free drug delivery system with Portal
Leo Pharma agreed to work with Portal Instruments to develop a needle-free jet injector platform for drug delivery. Under the terms of the deal, Portal's system will be used in combination with Leo's investigational and approved medicines.
Drug Delivery Business News (12/5) 
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Funding round brings in $50M for Akoya
A funding round has raised $50 million for Akoya Biosciences, which intends to use the proceeds to support the development and commercialization of its Codex and Phenoptics spatial omics platforms.
GenomeWeb Daily News (free registration) (12/5) 
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New president appointed to Orthofix's global spine business
Orthofix has named Kevin Kenny as the president of its global spine business. Kenny was formerly a chief operating officer of Cardiovascular Systems and vice president of US sales at Medtronic Spine and Biologics.
MassDevice (Boston) (12/5) 
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4,800+ Medical Device Companies Adopt RAMS
EMERGO by UL's Regulatory Affairs Management Suite (RAMS), a digital medical device RA/QA management platform, has established itself as manufacturers' go-to resource for regulatory intelligence. Registration and premium services are free for a limited time.
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Science & Health
AI-based PET/CT algorithm may predict prostate cancer survival
Swedish and Danish researchers found that a deep learning-based algorithm quantifying PET/CT measurements of total prostate lesion uptake and abnormal voxel volume relative to total prostate volume -- but not age, Gleason score and prostate-specific antigen levels -- significantly predicted overall survival among patients with prostate cancer. The findings were published in Clinical Physiology and Functional Imaging.
Radiology Business (12/5) 
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Emerging Technologies
Micro-implant could aid patients with spinal cord injuries
A micro-implant that sends electrosignals from deep within the spine is being developed by University of Alberta researchers to help restore movement in patients with spinal cord injuries.
Becker's Spine Review (12/5) 
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Study: OCT technique allows real-time detection of colorectal cancer
A study to be published in Theranostics and based on about 26,000 optical tomography images from colorectal tissue samples found that an OCT-based imaging technique paired with deep learning had 100% accuracy in detecting tumors in real time, compared with pathology reports. Researchers also found that the technique had 100% sensitivity and 99.7% specificity in making colorectal cancer diagnoses, compared with using traditional histology.
AuntMinnie (free registration) (12/6) 
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Government & Regulatory
Medtronic recall of SynchroMed II categorized as Class I
The voluntary recall of some Medtronic SynchroMed II implantable drug infusion pumps was categorized as a Class I recall by the FDA. The devices were recalled because of a foreign particle that interfered with the gear rotation of the pump, which could cause the device to stall.
MedTech Dive (12/5) 
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FDA grants breakthrough status to Vicarious' surgical robot
Vicarious Surgical's miniaturized surgical robot received breakthrough device status from the FDA. The device enables single micro-incision surgeries, according to Vicarious.
MedTech Dive (12/5) 
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Roche's MRSA assay gains FDA nod
Roche's cobas vivoDx MRSA diagnostic test has received FDA approval for the detection of methicillin-resistant Staphylococcus aureus bacterial colonization. The test can generate results from nasal swab samples within five hours.
Seeking Alpha (12/5) 
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