FDA Updates Steps to Make Power Morcellators Safer in Surgery FDA Updates Steps to Make Power Morcellators Safer in Surgery
Laparoscopic power morcellation for myomectomy or hysterectomy should only be performed with an approved tissue containment system and only in appropriately selected patients.News Alerts (Source: Medscape Pulmonary Medicine Headlines)
Source: Medscape Pulmonary Medicine Headlines - February 25, 2020 Category: Respiratory Medicine Tags: Ob/Gyn & Women ' s Health News Source Type: news
Today the @US_FDA announced several important steps the agency is taking to make the use of laparoscopic power morcellators (LPMs) safer in gynecologic surgeries. https://go.usa.gov/xdyV4 pic.twitter.com/MmJTOblYFS
Today the @US_FDA announced several important steps the agency is taking to make the use of laparoscopic power morcellators (LPMs) safer in gynecologic surgeries. https://go.usa.gov/xdyV4 pic.twitter.com/MmJTOblYFS (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 25, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news
Why Human Factors Terminology Needs Updating
Conclusion
IEC 62366-1 leaves a chasm between Normal Use and Abnormal Use, so manufacturers might not consider some user actions to be “Use Errors†if these actions do not fit the IEC 62366-1 definition of use. In other words, Use Errors may go undetected, unaddressed, or unmitigated. To protect users and manufacturers, this gap must be closed: IEC 62366-1 should be updated to address user actions that do not fit the current definitions of Normal Use nor Abnormal Use. To mend this gap in IEC 62366-1, we suggest to:
Re-define Abnormal Use in terms of abuse.
Remove Normal Use.
Remove the &...
Source: MDDI - February 19, 2020 Category: Medical Devices Authors: Kaivon Assani Tags: Design Source Type: news
Intuitive Surgical & #039;s Latest Acquisition Is Just One Piece of a Much Bigger Puzzle
There has been an imeasurable amount of disucssion in the medical device industry in recent years about the future of robotic surgery as the market pioneer Intuitive Surgical welcomes an influx of competition into the space. One of the ways Intuitive is continuing to innovate in the field is through connectivity and data analytics.
Through an intriguing discussion at MD&M West, along with Intuitive's announcement earlier this week that it has acquired Orpheus Medical, MD+DI gained a clearer understanding of how those trends are being put to work at Intuitive to turn expert surgeons into super-ex...
Source: MDDI - February 12, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Tackling the Weight List Problem Tackling the Weight List Problem
Laparoscopic sleeve gastrectomy may help improve kidney transplant candidacy among morbidly obese patients, but important questions remain.American Journal of Transplantation (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - February 12, 2020 Category: Surgery Tags: Transplantation Journal Article Source Type: news
3 Things I Learned at MD & amp;M West on Day 1
1. The Ever-Evolving Digital Age Is Creating Super Surgeons
Using his fellow panelist Christopher Macomber, MD, as an example, Kyle Miller, MD, explained how emerging technology like machine learning and automated performance metrics can create "super surgeons." But it's going to require acceptance by the surgeons. Miller is the senior global clinical marketing manager at Irvine, CA-based Intuitive Surgical, and Macomber is chair of robotic surgery at Minneapolis, MN-based Abbott Northwestern Hospital, part of Allina Health Surgical Specialists.
"If you think about a user like Chris, and all of thes...
Source: MDDI - February 11, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Minimally Invasive Surgery Through the Eyes of a Surgeon
One of the best parts of an event like MD&M West is the opportunity to put a cross-section of experts from industry in the same room as engineers and end-users and talk about the biggest trends in medical devices. One such discussion that took place here in Annaheim, CA on Tuesday included an expert robotic surgeon, an expert from Intuitive Sugical (which, as you likely know by now, pioneered robotic surgery a little more than 20 years ago), and a new robotic surgery company that is trying to to take this technology beyond the surgical suite.
I shared a few insights from this lively panel discussion here, but prior to...
Source: MDDI - February 11, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Do Your Devices Meet Physicians ’ Needs?
You’ve invested a lot of time ensuring your medical device meets user needs, but could those needs have changed? As healthcare evolves thanks to robotics, value-based care, the rise of ambulatory surgery centers, remote procedures, and more, the needs of surgeons and other physicians and healthcare practitioners are evolving, too.
Physicians will come together at the upcoming MD&M West 2020 conference to discuss what is missing in the world of medtech in the panel discussion, Tech Talk Panel: Physician's Perspectives: Unmet Needs, Design, & New Technologies in Medtech.
Participating on the panel w...
Source: MDDI - February 7, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Design Source Type: news
Sensing Changes in Remote and Surgical Devices
The role of sensors in medical devices is becoming increasingly more important, especially when it comes to developing new technologies such as wearable devices that can diagnose and transmit information for long periods of time. Recent developments in sensor technologies are driving the trend toward the decentralization of healthcare by putting diagnostic instruments in the hands (or on the bodies) of patients. The move toward miniaturization in medical devices has also enabled sensors to be placed on laparoscopic instruments, providing surgeons with valuable haptic feedback.
Experts will examine sensor advancements in th...
Source: MDDI - February 6, 2020 Category: Medical Devices Authors: Susan Shepard Tags: Electronics Source Type: news
A Revolution in Laparoscopic Training: KARL STORZ and VirtaMed Leap Beyond VR Simulation
TUTTLINGEN, Germany and ZURICH, Feb. 3, 2020 -- (Healthcare Sales & Marketing Network) -- KARL STORZ, the leading endoscopy manufacturer, and VirtaMed, world leader in medical training simulation, introduce a novel mixed reality simulator bringing innovat... Devices, Product Launch KARL STORZ, VirtaMed, endoscopy, medical training simulation, LapTrainer (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 3, 2020 Category: Pharmaceuticals Source Type: news
Study: How to safely remove ovary in girls for best results in fertility preservation
(Ann& Robert H. Lurie Children's Hospital of Chicago) Using an experimental piglet model, researchers defined the safest laparoscopic technique for removing the ovary in young girls that also results in the best quality ovarian tissue for fertility preservation. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - February 3, 2020 Category: International Medicine & Public Health Source Type: news
Can Intuitive Surgical Still Be Heard Above Noisy Competition?
A noisier competitive environment in surgical robotics means elongated price negotiation timelines and delayed deals for Intuitive Surgical, but the market pioneer seems prepared to handle that noise.
"We definitely see increasing conversations as [competitors] get closer to market with what they want to do or other companies are starting to get some clearances in other regions," Intuitive Surgical CEO Gary Guthart said during the company's most recent earnings call in response to an analyst's question. "I think that customers are interested in listening to other pitches. I think we’re pretty ...
Source: MDDI - January 27, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Robotic Surgery Saw 8.4-Fold Increase From 2012 to 2018
TUESDAY, Jan. 14, 2020 -- Hospitals that launch robotic surgery programs have a broad and immediate increase in the use of robotic surgery, accompanied by a decrease in traditional laparoscopic minimally invasive surgery, according to a study... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 14, 2020 Category: Pharmaceuticals Source Type: news
Blood Test Gives Greater Insight on Heart Attack Risk After Surgery
A common cardiac blood test done before surgery can predict who will experience adverse outcomes after most types of surgery, said researchers from Hamilton Health Sciences.
The VISION study looked at whether levels of a cardiac blood test, NT-proBNP, measured before surgery can predict cardiac and vascular complications. Higher levels of NT-proBNP, which can be caused by various anomalies in the cardiac muscle, such as stress, inflammation or overstretch, can help identify which patients are at greatest risk of cardiac complications after surgery.
The study included 10,402 patients aged 45 years or older having non-cardia...
Source: MDDI - December 30, 2019 Category: Medical Devices Authors: MDDI Staff Tags: IVD Source Type: news
Group Chat Allows Instant Grading of Intraoperative Cholecystectomy Images Group Chat Allows Instant Grading of Intraoperative Cholecystectomy Images
A multimedia messaging service (MMS) group chat can be used real-time to grade images during laparoscopic cholecystectomy, researchers report.Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - December 26, 2019 Category: Surgery Tags: General Surgery News Source Type: news
