New Rules Aimed To Make Clinical Trials Safer, More Effective

New Rules

Universities and drug companies that use human volunteers for research face tough new rules designed to make sure that valuable information from these volunteers is widely available, not only to the volunteers themselves but to scientists trying to advance medical science. The rules currently on the books are confusing and often ignored. Since 2007, scientists…

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Computer program beats physicians at brain cancer diagnoses

Computer

Computer programs have defeated humans in Jeopardy!, chess and Go. Now a program developed at Case Western Reserve University has outperformed physicians on a more serious matter. The program was nearly twice as accurate as two neuroradiologists in determining whether abnormal tissue seen on magnetic resonance images (MRI) were dead brain cells caused by radiation,…

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World’s First: Robot Operates Inside Eye – see the video

robot

University of Oxford surgeons at Oxford’s John Radcliffe Hospital have performed the world’s first operation inside the eye using a robot. Robert MacLaren, Professor of Ophthalmology. assisted by Dr Thomas Edwards, Nuffield Medical Fellow, used the remotely controlled robot to lift a membrane 100th of a millimeter thick from the retina at the back of…

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FDA Clears Omega3-Rich Fish Skin for Surgical Applications

fish skin

MCLEAN, VA–(Marketwired – Sep 13, 2016) – Kerecis, the company using Omega3-rich fish skin for tissue healing, has received clearance from the Food and Drug Administration (FDA) to market the proprietary Kerecis technology as a surgical buttress in the United States. The Kerecis Omega3 SecureMesh can be used in lung, bariatric, gastric, colorectal and other…

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Kolo Medical Introduces Next Gen SiliconWave™ Ultrasound Transducers

ultrasound transducers

SAN JOSE, Calif., Sept. 9, 2016 /PRNewswire/ — Expanding its suite of next generation ultrasound transducers based on semiconductor technologies, Kolo Medical announced today that it will introduce three new SiliconWave™ transducers at the 2016 IEEE International Ultrasonics Symposium (IUS) in Tours, France, September 18-21, 2016. SiliconWave transducers, designed to deliver an unprecedented level of performance in…

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10 Things I Wish I’d Known Before Writing my FDA Response Letter

FDA

If you’ve ever received a 483 or warning letter, as I have, you know the chaos that can ensue. The clock is ticking; the FDA requires a response to most compliance notices within 15 business days! I received a warning letter while working for a leading global manufacturer of dental materials, devices, and instruments. As…

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Men Have Twice the Myocardial Infarction (MI) Risk Compared to Women 

Myocardial Infarction

Men had nearly twice the risk of Myocardial Infarction (MI) compared with women even after adjusting for coronary heart disease risk factors such as serum lipid levels, blood pressure, smoking, diabetes, body mass index and physical activity, according to a study in Norway. The difference between genders remained similar throughout most of their lives, although…

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Insulet Enrolls First Patients in Clinical Trial for Omnipod® Artificial Pancreas System

Insulet

BILLERICA, Mass.–(BUSINESS WIRE)–Insulet Corporation (PODD) (Insulet or the Company), the leader in tubeless insulin pump technology with its Omnipod® Insulin Management System (Omnipod System), today announced the first patient has completed the feasibility study of the Omnipod Horizon™ Automated Glucose Control System (Omnipod Horizon System). The full study will evaluate the use of a personal Model Predictive Control algorithm…

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3 Tips for Negotiating That “Perfect” Compensation Package (includes resources for you in your research)

compensation package

As professionals, we should be prepared to negotiate a compensation package that accurately reflects their value. However, many candidates avoid negotiations because they are uncomfortable or unaware of their market value. If you’re a senior level executive (or even a senior level hiring manager), here’s a method for making sure you never have an offer rejected:…

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ExplORer Surgical Nabs $1M for Real-Time Mobile Surgical Playbook

surgical playbook

ExplORer Surgical, a Chicago-based startup has raised $1 million in seed funding for its real-time mobile-based surgical playbook that promotes optimal teamwork in the operating room. Investors in the seed round include CJM Ventures, M25 Group, SymphonyAlpha Ventures, The University of Chicago Innovation Fund, Wasson Enterprise, along with several prominent healthcare and technology angel investors.…

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