The Trump administration this week submitted a proposal that would cut the budget and staff at the FDA, as well as reorganizing the agency to remove food regulation from its purview, according to a new Endpoints News report. The proposal would cut $1.3 billion in resources from the agency and 5,000 members of its staff […]
Study: No difference in complications, survival rate between robot-assisted and open bladder surgeries
June 22, 2018 By Leave a Comment
A seven-year study comparing outcomes from robotic and open cystectomy procedures showed no statistically significant difference in complications or survival rate between the two methods. The randomized open versus robotic cystectomy study, known as the Razor trial, is touted as the first comprehensive study to compare outcomes between robotic and traditional open surgeries in any […]
Johnson & Johnson hits the Big Apple with latest JLabs site
June 21, 2018 By Leave a Comment
Johnson & Johnson (NYSE:JNJ) opened its latest life science incubator in New York City, the healthcare giant said today. The 30,000-square-foot JLabs @ NYC is a collaboration between Johnson & Johnson Innovation, New York State and the New York Genome Center. Sited at the genome center in SoHo, the incubator is home to 26 startups and
No-shows at radiology can cost a hospital $1 million a year, study says
June 20, 2018 By Leave a Comment
People who fail to show up for radiology appointments cost hospitals about $1 million per year on average, according to a new study. That’s as much as the cost of a new 3T MR scanner. Most of the no-shows at academic medical centers were for mammography appointments, according to the study, published in Current Problems
Hey, Google! When will I die?
June 20, 2018 By Leave a Comment
Google’s AI capabilities can predict with greater accuracy than a hospital’s computers when a critically ill patient will die, according to a new study. Using a patient’s entire chart, Google’s deep learning methods were able to predict, 24 hours after admission, the risk of that patient’s death at 19.9% while the regular hospital’s computers predicted
Johnson & Johnson launches new self-shortening Dynacord suture
June 20, 2018 By Leave a Comment
Johnson & Johnson through its DePuy Synthes franchise has announced the U.S. launch of its Dynacord suture for soft tissue repair in areas such as the rotator cuff in the shoulder. The Dynacord suture, available on Healix Advance anchors, is part of the DePuy Synthes Mitek Sports Medicine portfolio. J&J launched Dynacord today at the San
Stocks slide further as Trump doubles down on China tariffs
June 19, 2018 By Leave a Comment
The Trump administration yesterday added $200 billion worth of tariffs to the $50 billion in trade levies already slated to go into place next month and threatened to add $200 billion more, sending share prices down. The news put the Dow Jone Industrial Average on track for its longest losing streak in 15 months and
Bronchoscopes still dirty after cleaning, study says
June 19, 2018 By Leave a Comment
A new study has found that currently acceptable methods of reprocessing reusable bronchoscopes left most devices contaminated and damaged. “The results are worrisome as patients undergoing bronchoscopy are commonly at high risk for infection due to transplant status, critical illness, or immune-suppression due to malignancy or chronic disease,” said the study, funded by 3M and
SetPoint Medical touts 2-year relief from rheumatoid arthritis
June 19, 2018 By Leave a Comment
Startup SetPoint Medical has demonstrated “significant, sustained improvement” over two years in a first-in-human study using bioelectronic therapy in patients with rheumatoid arthritis (RA). Seventeen subjects with moderate to severe symptoms were implanted with a vagus nerve stimulator in the European study. At three months, the therapy was shown to have significantly reduced RA symptoms
Study finds nearly half of people with diabetes skip care due to costs
June 18, 2018 By Leave a Comment
A newly-published report from UpWell Health found that nearly half of Americans with diabetes have skipped medical care at times because they couldn’t afford it. The 5,000-person survey showed that diabetes doesn’t just take a financial toll on people’s lives – it can impact their relationships, too; 37% of respondents reported that diabetes has harmed
Paragonix Technologies aims to boost survival of donated lungs
June 18, 2018 By Leave a Comment
Many lungs being transported for transplant arrive in such bad shape that they cannot be used. Paragonix Technologies aims to change that with SherpaLung, a specialized cooler that keeps lungs properly inflated and at the right temperature to survive an airplane trip. Paragonix Technologies just landed support from the Lung Transplant Foundation to continue developing and commercializing
DreaMed Diabetes wins FDA authorization to market insulin therapy management platform
June 18, 2018 By Leave a Comment
DreaMed Diabetes said today that U.S. FDA has granted a de novo request for DreaMed Advisor Pro, its AI-based diabetes treatment decision support software. The news comes about four months after the Petah Tikva, Israel–based company won CE Mark clearance for the decision-support platform, which is meant to help healthcare professionals manage insulin therapy for people with Type
Mack Molding investing millions into N.C., Vermont facilities
June 15, 2018 By Leave a Comment
Mack Molding (Arlington, Vt.) recently announced that it is hiring and investing millions of dollars at its Statesville, N.C. facility and its three Vermont locations. “The resurgence of manufacturing in the United States is strong, and Mack has been aggressive in ensuring we are well-positioned to seize the opportunity presented to us,” Jeff Somple, Mack’s president,
Here’s how FDA officials think you can legally promote off-label device, drug uses
June 13, 2018 By 2 Comments
The FDA has issued final guidance clarifying what it considers permissible off-label information for device makers and drug companies to convey to potential customers. A pair of guidance documents outlines how medtech and pharmaceutical companies can explain to payors and hospitals how their products can affect outcomes and potentially save money, beyond what the products’ indication with the
Medtronic warns on external pacemaker issues
June 13, 2018 By Leave a Comment
Medtronic (NYSE:MDT) has released an urgent field safety notice warning of issues with a subset of its model 53401 single chamber external pacemakers in which the device may experience an unexpected power on reset. The Fridley, Minn.-based company said that the issue is due to an initial version of the firmware for the device which allowed […]
