House bill would ban Bayer’s Essure
A bill introduced by Rep. Mike Fitzpatrick (R-Pa.) would ban U.S. sales of the Essure female sterilization implant made by Bayer (ETR:BAYN). The “E-Free Act” or H.R. 3920 was introduced Nov. 4 and has 3 co-sponsors: Reps. Marsha Blackburn (R-Tenn.), Gregorio Sablan (I-N. Mariana Islands) and Christoper Smith (R-N.J.). It would direct the FDA commissioner to withdraw approval for the Essure device, the only approved permanent birth control device in the U.S. Essure is a small metal coil that is placed in the fallopian tubes via catheter. The FDA approve...
Source: Mass Device - November 9, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Legal News Women's Health Bayer HealthCare Source Type: news

Laparoscopic Pancreaticogastrostomy/PancreaticoduodenectomyLaparoscopic Pancreaticogastrostomy/Pancreaticoduodenectomy
This new surgical technique may be a useful method of performing pancreaticogastrostomy in pure laparoscopic pancreaticoduodenectomy. BMC Surgery (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 4, 2015 Category: Consumer Health News Tags: General Surgery Journal Article Source Type: news

Cost to treat low-risk prostate cancer can vary widely, UCLA study finds
How much does it actually cost to treat low-risk prostate cancer? A team of UCLA researchers are the first to describe the cost throughout the entire process for men being treated for low-risk prostate cancer — from their first appointment to post-treatment follow-up testing. Analyzing several different types of cancer treatment that were available throughout the entire 12-year study period, the researchers found a wide variance in costs. The research indicates that there may be a better way to monitor costs and keep them in check for patients, said Dr. Aaron Laviana, the study’s first author. “As we move...
Source: UCLA Newsroom: Health Sciences - November 3, 2015 Category: Universities & Medical Training Source Type: news

Nigeria: LUTH Procures Laparoscopic Machine for Keyhole Surgery Training
[Vanguard] In line with advancement in surgery procedures particularly in knifeless surgery, the Lagos University Teaching Hospital, LUTH, Idi Araba, Lagos, has procured a Medtronic Laparoscopic Simulator machine valued at 80,000 Euros for the training of laparoscopic surgeons in Nigeria and beyond. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - October 23, 2015 Category: African Health Source Type: news

Chinese VC Virtus gets in on $1m round for Gordian Surgical
Trendlines Medical portfolio company Gordian Surgical said today it raised nearly $1 million in a new round of funding joined by Chinese venture capital firm Virtus Inspire Ventures. Gordian is developing a trocar device that inserts sutures into tissue surrounding incisions at the beginning of a procedure and anchors them in place throughout the operation, the company said. “I am extremely pleased by the growing level of interest in our company and technology. This investment by a VC and senior surgeons is evidence of the confidence in our team and in the market potential of our products,” Gordian Surgica...
Source: Mass Device - October 20, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Surgical Gordian Surgical The Trendlines Group Source Type: news

FDA clears SonaCare HIFU prostate device, prompts Edap to yank de novo, go for 510k
SonaCare said it won FDA pre market approval for its high intensity focused ultrasound device designed to treat prostate cancer, causing competitor EDAP (NSDQ:EDAP) to yank the de novo application for its Ablatherm HIFU. SonaCare said its Sonablate 450 will be available in the U.S. this October. “The FDA regulatory authorization to market Sonablate in the U.S. is a milestone for non-invasive prostate care and a tremendous gain for men’s health. Men all over the world, in the more than 49 countries where it has already been authorized for use, have had access to this technology for prostate ablation. There ...
Source: Mass Device - October 16, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Oncology Pre-Market Approval (PMA) Regulatory/Compliance EDAP TMS SA SonaCare Medical Source Type: news

Essure Contraceptive Implant Tied to Higher Reoperation Rates Essure Contraceptive Implant Tied to Higher Reoperation Rates
A study comparing implant-based hysteroscopic sterilization with laparoscopic sterilization has found that implant failure or migration increased risk for reoperation within 1 year of the procedure. Medscape Medical News (Source: Medscape ObGyn and Womens Health Headlines)
Source: Medscape ObGyn and Womens Health Headlines - October 15, 2015 Category: OBGYN Tags: Ob/Gyn & Women ' s Health News Source Type: news

Essure Sterilization Device Linked to Greater Need for Reoperation (FREE)
By Amy Orciari Herman Edited by Susan Sadoughi, MD Hysteroscopic sterilization with the Essure implant, compared with more traditional laparoscopic sterilization, is associated with a 10-fold increase in the need for reoperation within 1 year, a BMJ … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - October 15, 2015 Category: Primary Care Source Type: news

Study finds higher surgery risk with Bayer’s Essure
(Reuters) — Women implanted with Bayer‘s (ETR:BAYN) Essure female sterilization device were more than 10 times more likely to require post-procedure surgery than those who underwent laparoscopic sterilization, according to a study published today in the British Medical Journal. The findings could cast additional doubt on the safety of the Bayer device, which was approved in 2002 as an alternative to surgical sterilization and acquired by Bayer in 2013. It has faced recent scrutiny from U.S. health regulators following numerous patient complaints and calls for its withdrawal from the market. By 1&...
Source: Mass Device - October 14, 2015 Category: Medical Equipment Authors: MassDevice Tags: Clinical Trials Food & Drug Administration (FDA) Gynecological Regulatory/Compliance Women's Health Bayer HealthCare Source Type: news

Essure sterilisation implant has 'high risk' of complications
ConclusionThe results of this study seem clear: women undergoing hysteroscopic sterilisation are more likely to need a repeat operation than women undergoing the standard laparoscopic sterilisation. However, we don’t know why.The study indicates that women having the newer procedure may have a higher risk of complications because of their age, and previous problems such as pelvic inflammatory disease. Although the researchers took these issues into account, they may have missed other factors contributing to the results. One additional factor is that all women undergoing a hysteroscopy have a standard check three mont...
Source: NHS News Feed - October 14, 2015 Category: Consumer Health News Tags: Medical practice Pregnancy/child Source Type: news

Higher risk of surgery seen with Bayer Essure contraceptive: study
(Reuters) - Women implanted with Bayer AG's Essure permanent contraception device were more than 10 times more likely to require post-procedure surgery than those who underwent laparoscopic sterilization, a study published on Tuesday found. (Source: Reuters: Health)
Source: Reuters: Health - October 14, 2015 Category: Consumer Health News Tags: healthNews Source Type: news

Fisher & Paykel launch 2 new products, see shares rise
Fisher & Paykel (NZE:FPH) said today it launched a new Eson 2 Nasal mask and HumiGard SH870 surgical humidification system, sending shares up to their highest since late last month. The Eson 2 nasal mask is designed to work with systems designed for the treatment of obstructive sleep apnea. The mask uses the comapny’s RollFit seal technology that adjusts to fit a range of face shapes and minimize pressure on the nose, Fisher & Paykel said. “Our development team has focused on ease of use, to provide sleep professionals and patients confidence at every step from titration through to adherence. The F&...
Source: Mass Device - October 13, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Respiratory Fisher & Paykel Healthcare Source Type: news

Laparoscopic Lavage Worse Than Resection in DiverticulitisLaparoscopic Lavage Worse Than Resection in Diverticulitis
Laparoscopic lavage failed to reduce postoperative complications in emergency diverticulitis surgery and was associated with a higher reoperation rate compared with resection in a randomized trial. Medscape Medical News (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - October 8, 2015 Category: Surgery Tags: Gastroenterology News Source Type: news

Sleeve Gastrectomy Normalizes Testosterone in Some Obese MenSleeve Gastrectomy Normalizes Testosterone in Some Obese Men
The laparoscopic bariatric procedure appears to offer yet another health benefit, and could be a better alternative to testosterone replacement therapy, a new study indicates. Medscape Medical News (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - October 7, 2015 Category: Surgery Tags: General Surgery News Source Type: news

Laparoscopic Lavage for Perforated Diverticulitis? Probably Not. (FREE)
By Amy Orciari Herman Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM Laparoscopic lavage is no better than colon resection for treating perforated diverticulitis — and might even lead to worse outcomes — according to a … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - October 7, 2015 Category: Primary Care Source Type: news

Laparoscopic Surgery for Rectal Cancer? Not Yet, Say TrialsLaparoscopic Surgery for Rectal Cancer? Not Yet, Say Trials
The emergent surgical approach failed to show it was noninferior to the traditional approach of open resection. Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - October 6, 2015 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news

Is this hysterectomy really happening to me – Karen’s story
The post Is this hysterectomy really happening to me – Karen’s story appeared first on Hysterectomy Association. The start of my story was a particularly bad period back in January this year, resulting in a visit to the Doc and a referral to gyne at local hospital, an ultra sound showed up a polyp which was removed 6 weeks later in day surgery. Nothing could have prepared me for what happen next! I was asked to attend and emergency MRI scan and Gynaecology consult (4 weeks post polypectomy) to discover that the polyp was cancerous and the MRI was to check that it was contained with in my womb, (this meeting was...
Source: The Hysterectomy Association - October 6, 2015 Category: OBGYN Authors: Linda Parkinson-Hardman Tags: Your Stories cancer polyp polypectomy Source Type: news

Routine use of laparoscopic surgery for rectal cancer still to be established
A comparison of the surgical removal of rectal tumors by a laparoscopically assisted procedure and open surgery reveals that the case for routine use of laparoscopic procedures has not yet been established, according to a randomized control-trial study. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - October 6, 2015 Category: Science Source Type: news

Routine use of laparoscopic surgery for rectal cancer still to be established
(University of Sydney) A comparison of the surgical removal of rectal tumors by a laparoscopically assisted procedure and open surgery reveals that the case for routine use of laparoscopic procedures has not yet been established, according to a randomized control-trial study published today in the Journal of the American Medical Association. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - October 6, 2015 Category: Cancer & Oncology Source Type: news

Findings do not support routine use of minimally invasive surgery for rectal cancer
(The JAMA Network Journals) Compared to open resection (surgical removal) for rectal cancer, minimally invasive laparoscopic-assisted resection did not provide better cancer outcomes, according to two studies in the Oct. 6 issue of JAMA. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - October 6, 2015 Category: Cancer & Oncology Source Type: news

Weight loss surgery offers new hope to children, adolescents with Prader-Willi Syndrome
Obesity is a leading cause of complications and death in children suffering from Prader-Willi syndrome (PWS), yet there are few effective treatment options for these patients. In a new study, researchers found that bariatric surgery, specifically laparoscopic sleeve gastrectomy (LSG), resulted in substantial weight loss with no apparent adverse effect on growth in a small group of severely overweight patients with PWS. PWS is a rare genetic condition that causes a wide range of problems including a constant desire to consume food, which is driven by a permanent feeling of hunger. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - September 28, 2015 Category: Science Source Type: news

Weight loss surgery offers new hope to children and adolescents with Prader-Willi Syndrome
(Elsevier Health Sciences) Obesity is a leading cause of complications and death in children suffering from Prader-Willi syndrome (PWS), yet there are few effective treatment options for these patients. In a new study researchers found that bariatric surgery, specifically laparoscopic sleeve gastrectomy (LSG), resulted in substantial weight loss with no apparent adverse effect on growth in a small group of severely overweight patients with PWS. While bariatric surgery is considered controversial for PWS, the research team is encouraged by their positive results. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - September 28, 2015 Category: Global & Universal Source Type: news

Report: Feds to investigate power morcellators
The Government Accountability Office said last week it will investigate potential safety and regulatory issues with laproscopic power morcellators, according to The Wall Street Journal. The devices use small, rotating blades to break up large tissue masses into fragments, and are commonly used to remove uterine fibroids in women. However, if the device is used on a patient with an undetected cancerous growth, it can enable the cancer to spread, according to the FDA. The tools have been under the scrutiny of the FDA for over a year – last November, the agency released a security communication warning that women underg...
Source: Mass Device - September 11, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Gynecological Regulatory/Compliance Women's Health U.S. Government Accountability Office (GAO) Source Type: news

Cambridge Endo files for Chapter 11 bankruptcy
Cambridge Endoscopic Devices yesterday filed for Chapter 11 bankruptcy protection, saying it owes creditors $17 million but has assets of only $3 million. The Framingham, Mass.-based medical device company, which made medical devices used for single-incision laparoscopy procedures, closed a debt-and-options offering worth $2.9 million in January 2014. A Chapter 11 bankruptcy allows the organization to re-form after settling its current debts. Cambridge Endo’s filing lists 4 parties as major creditors, including White Sand Beach (owed more than $8.1 million, $2.6 million secured) and...
Source: Mass Device - September 4, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Business/Financial News Endoscopic / Arthroscopic Wall Street Beat Cambridge Endoscopic Devices Inc. Source Type: news

Sanofi’s Genzyme pays $33m, enters DPA in criminal Seprafilm case
(Reuters) — Genzyme agreed to pay $32.59 million, admit wrongdoing and enter a deferred prosecution agreement to resolve criminal charges over its marketing of the surgical implant Seprafilm, the U.S. Justice Dept. said yesterday. The biotechnology unit of French drug company Sanofi (NYSE:SNY) was accused of 2 misdemeanor counts of violating the federal Food, Drug and Cosmetic Act from 2005 to 2010 by allowing Seprafilm to be adulterated and misbranded while being sold. Sanofi bought Genzyme in 2011. Seprafilm is a clear film used to reduce abnormal internal scarring that can cause organs and tiss...
Source: Mass Device - September 4, 2015 Category: Medical Equipment Authors: MassDevice Tags: Legal News Surgical Genzyme Corp. Sanofi-Aventis Source Type: news

Medeon Biodesign Receives FDA 510(k) Clearance for ClickClean Laparoscope Lens Cleaning Device
Medeon Biodesign, Inc.,aTaiwanmedical device company, has received U.S. Food and Drug Administration 510(k) clearance for ClickClean, a lens cleaning device. ClickClean provides instant, in-situ, one-click lens cleaning during laparoscopic procedures, which virtually eliminates the need to remove the laparoscope from the body cavity during surgery and significantly reduces the total time, cost, risks and repeated frustration associated with maintaining a clear visual field. (Source: Medical Design Online News)
Source: Medical Design Online News - August 25, 2015 Category: Medical Equipment Source Type: news

Does Laparoscopic Hysterectomy Lead to Better Outcomes?Does Laparoscopic Hysterectomy Lead to Better Outcomes?
Dr Peter Kovacs reviews results of a paper that used a decision-analysis model to study all-cause morbidity and mortality with laparoscopic and abdominal hysterectomy for presumed benign fibroids. Medscape Ob/Gyn (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - August 17, 2015 Category: Consumer Health News Tags: Ob/Gyn & Women ' s Health Viewpoint Source Type: news

Addressing Morbid Obesity as a Renal Transplantation BarrierAddressing Morbid Obesity as a Renal Transplantation Barrier
Is laparoscopic sleeve gastrectomy a safe and effective way to get obese patients ready for kidney transplantation? American Journal of Transplantation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - August 11, 2015 Category: Consumer Health News Tags: Transplantation Journal Article Source Type: news

Ovarian Remnant Syndrome – Sue’s story
The post Ovarian Remnant Syndrome – Sue’s story appeared first on Hysterectomy Association. After suffering with endometriosis I decided at the age of 35 that I wanted a hysterectomy (despite having no children). Since the age of 13 I had suffered with severe period pain. When I was 26 I saw a gynaecologist (Mr W), who decided to do a D&C, this did not help with the pain so Mr W then did a laparoscopy. I was diagnosed with extensive endometriosis. I then began a course of Zoladex injections. At the end of the course I had another laparoscopy and the endometriosis was no more. Was I cured? NO! Three months l...
Source: The Hysterectomy Association - August 9, 2015 Category: OBGYN Authors: Linda Parkinson-Hardman Tags: Your Stories endometriosis ovarian remnant syndrome Source Type: news

Benefits of Sleeve Gastrectomy Wane at 5 Years Benefits of Sleeve Gastrectomy Wane at 5 Years
A study finds that short-term weight loss and diabetes remission achieved with laparoscopic sleeve gastrectomy decline by 5 years. Medscape Medical News (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - August 7, 2015 Category: Endocrinology Tags: Diabetes & Endocrinology News Source Type: news

Robot-assisted surgery: Virtual Incision looks to grow by shrinking
Robot-assisted surgery is a hot space, dominated by large machines that resemble their automated, automotive-assembly-line ancestors: Large craning arms, industrial hydraulics with an array of tools, all hunched over an operating table. But a newly spun-out medical device company from the University of Nebraska, Virtual Incision, is looking to change that. The company, based out of both Pleasanton, Calif., and Lincoln, Neb., is developing a much smaller robot for minimally invasive surgeries, designed to operate from the inside out. The new, smaller robotic system is inserted through a single abdominal incision, where...
Source: Mass Device - August 6, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Robot-Assisted Surgery Virtual Incision Corp. Source Type: news

Laparoscopic Sleeve Gastrectomy: Initial Benefits Drop Off with Longer Follow-Up (FREE)
By Amy Orciari Herman Edited by Susan Sadoughi, MD Most patients who undergo laparoscopic sleeve gastrectomy experience weight loss and remission of obesity-related comorbidities in the short term, but the benefits decline with longer follow-up, according to an analysis in JAMA … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - August 6, 2015 Category: Primary Care Source Type: news

Long-term followup of type of bariatric surgery finds regain of weight, decrease in diabetes remission
While undergoing laparoscopic sleeve gastrectomy induced weight loss and improvements in obesity-related disorders, long-term followup shows significant weight regain and a decrease in remission rates of diabetes and, to a lesser extent, other obesity-related disorders over time, according to a study. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - August 5, 2015 Category: Science Source Type: news

Teleflex updates on Q2 earnings, FDA clearances, acquisitions, deals & study data.
This study, when combined with the 2 earlier independent studies by the same team, shows that using an Arrow CVC with antimicrobial protection from Teleflex makes sense from many perspectives. This study is further evidence that using an unprotected catheter may put both patients and a hospital’s bottom line at unnecessary risk. The Arrow CVC with Arrow+ard Technology has been repeatedly shown to improve patient safety even when the risk of infection is low, and it more than pays for itself in the process,” vascular access division prez Jay White said in a prepared statement. The Arrow catheter a...
Source: Mass Device - July 30, 2015 Category: Medical Equipment Authors: Fink Densford Tags: 510(k) Business/Financial News Cardiovascular Catheters Food & Drug Administration (FDA) MassDevice Earnings Roundup Mergers & Acquisitions Regulatory/Compliance Surgical Teleflex Source Type: news

Tiny Mechanical Wrists Could Expand Needlescopic Surgery Options
Vanderbilt scientists have added a new innovation to their existing steerable needle technology: a tiny flexible wrist. The technology will make it possible to perform even more delicate surgical procedures, such as suturing and tissue resection, using minimally invasive micro-laparoscopic techniques. (Source: Medical Design Online News)
Source: Medical Design Online News - July 27, 2015 Category: Medical Equipment Source Type: news

Mauna Kea wins CE Mark for Cellvizio 800
Mauna Kea (ENT:MKEA) said today it won CE Mark approval in the European Union for its Cellvizio 800 near-infrared platform for endomicroscopic navigation during minimally invasive surgery. The Cellvizio device is designed for use in a variety of surgical procedures, providing real time visualization at the microscopic level, Mauna Kea said. The device is now indicated for use in gastroenterology, pulmonary and urinary treatments, the Paris-based company said. “This new regulatory step underlines our growing efforts and presence in the surgical arena through an expanded and dedicated product line. With this ...
Source: Mass Device - July 23, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Imaging Regulatory/Compliance Surgical Mauna Kea Technologies Source Type: news

Total hysterectomy at 45 – Debbie’s story
The post Total hysterectomy at 45 – Debbie’s story appeared first on Hysterectomy Association. I was shocked to be told that a total hysterectomy was the best option for the large fibroids I had and given my mother had died of ovarian cancer, my ovaries would be taken too. I was scheduled for laparoscopic (keyhole) and I had it all planned in my mind, home next day, quicker recovery etc etc. woke up in recovery to be told keyhole wasn’t possible and I had the abdominal cut. My post op period was not great, very low blood pressure, abdominal drain still draining blood after 5 days, required 2 blood transfu...
Source: The Hysterectomy Association - July 19, 2015 Category: OBGYN Authors: Linda Tags: Your Stories fibroids total hysterectomy Source Type: news

The joys of being a woman – Catherine’s story
The post The joys of being a woman – Catherine’s story appeared first on Hysterectomy Association. 6 weeks on after laparoscopic hysterectomy – I seemed to be finally seeing the light at the end of the tunnel (forgive the analogy!) At 48 and years of heavy bleeding due mainly to a fibroid, I’d tried 2 coils- 1 fell out, 1 lodged itself in my cervix and then an ablation 22 months ago. This year turns out the scar tissue from the ablation was causing horrible blood and fluid build up in my womb- something I had not been warned about!). I’d had enough. I decided on private care and found a surgeo...
Source: The Hysterectomy Association - July 19, 2015 Category: OBGYN Authors: Linda Tags: Your Stories fibroids heavy bleeding laparascopic hysterectomy Source Type: news

Total Abdominal Hysterectomy – my experience first 6 weeks, Karen’s story
The post Total Abdominal Hysterectomy – my experience first 6 weeks, Karen’s story appeared first on Hysterectomy Association. I am 43 yrs old, have suffered abnormal smear test results, endometriosis and blocked fallopian tubes since my early 20’s, resulting in four unsuccessful rounds of IVF treatment, and more recently, increased heavy bleeding during my menstrual cycle. Prior to Christmas (2014) I underwent my third laparoscopy, in which large cysts were found on one ovary. Due to my history, I was offered a hysterectomy and given the choice of partial or total removal. From research, I believed mysel...
Source: The Hysterectomy Association - July 19, 2015 Category: OBGYN Authors: Linda Tags: Women's Health endometriosis total abdominal hysterectomy Source Type: news

TransEnterix offering goes over-allotment, raises $52m
TransEnterix (NYSE:TRXC) said today it exercised an underwriter’s over-allotment option for its most recent funding round, selling an extra 2 million shares of common stock at the public offering price of $3 per share. Stifel and RBC Capital Markets were book-runners for the round, with Raymond James, BTIG and Ladenburg Thalmann as co-managers. Proceeds from the original sale of 16.7 million shares and the additional 2 million shares netted TransEnterix an approximate $52 million, the company said. In June, TransEnterix said they hoped to make $46.2 million from the offering. Funds are slated to s...
Source: Mass Device - July 13, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Robot-Assisted Surgery Robotics Surgical TransEnterix Source Type: news

Lina Medical settles morcellator lawsuit
Lina Medical reportedly settled a product liability lawsuit filed over its Xcise laparoscopic power morcellator, a type of device that’s been linked with spreading uterine cancer during uterine fibroid removal surgeries. The lawsuit was filed in March 2014 by Scott Burkart in the U.S. District Court for Eastern Pennsylvania. Burkart’s wife, Donna Burkart, died Feb. 2, 2013, at age 53, 11 months after she underwent a robot-assisted supracervical hysterectomy and bilateral salpingectomy with uterine morcellation, according to court documents. Less than 2 weeks after her procedure, the lawsuit alleged, Burkar...
Source: Mass Device - July 6, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Blog Source Type: news

Fourth of July grilling tip: Check for stray bristles after cleaning with a wire brush
Like millions of Americans, I plan to fire up the grill today for a Fourth of July cookout. But I’ll be adding an extra step to my routine: checking the grate for bristles that may have fallen off my cleaning brush. Over the years, a handful of reports in medical journals have chronicled injuries due to eating grilled food with a stowaway — a wire bristle from a grill-cleaning brush. Earlier this year, a team of Harvard-affiliated doctors described how they removed a wire bristle from a woman who went to an emergency room with pain in her throat that started after eating a chicken breast prepared on a grill. In...
Source: New Harvard Health Information - July 4, 2015 Category: Consumer Health News Authors: Patrick J. Skerrett Tags: Healthy Eating Safety Source Type: news

Lawsuit Over Hysterectomy Tool Settled
A federal lawsuit against a manufacturer of laparoscopic power morcellators that was expected to be the first to reach a trial has been settled for an undisclosed amount, an attorney for the plaintiff said. (Source: WSJ.com: Health)
Source: WSJ.com: Health - July 2, 2015 Category: Pharmaceuticals Tags: PAID Source Type: news

Diabetes: Study finds bariatric surgery beats diet, exercise
A study designed to compare bariatric surgery with lifestyle interventions found that Type II diabetics treated with gastric bypass or banding procedures fared better than patients who watched their diets and exercised. Results from “Bariatric Surgery versus Intensive Medical Therapy for Diabetes – 3-Year Outcomes,” which was funded by Johnson & Johnson (NYSE:JNJ) subsidiaries Ethicon and LifeScan, the Cleveland Clinic and the National Institutes of Health, were published online yesterday in the Journal of the American Medical Assn. The 3-year, 61-patient study randomized obese subjects...
Source: Mass Device - July 2, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Weight loss Journal of the American Medical Assn. (JAMA) Source Type: news

TransEnterix prices follow-on offering at $3 per share
TransEnterix (NYSE:TRXC) yesterday priced a $50 million follow-on offering at $3 per share, raising gross proceeds of $50 million for its SurgiBot robot-assisted surgery device. The Research Triangle Park, N.C.-based company said it expects to net about $46.2 million from the offering, which it plans to use on R&D, sales, marketing and commercialization of the SurgiBot device. The offering is expected to close June 17, TransEnterix said, and includes a 30-day underwriters’ over-allotment option for another 2.5 million shares. Stifel and RBC Capital Markets will be book-runners on the offering, with Raym...
Source: Mass Device - June 12, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Business/Financial News Funding Roundup Robot-Assisted Surgery Source Type: news

Insurer to Still Cover Device Despite Danger of Uterine Cancer's Spread
Health Care Service Corp., the nation’s fourth-largest health insurer, will continue to cover laparoscopic power morcellators after considering a policy that would have curbed the surgical tools used in hysterectomies. (Source: WSJ.com: Health)
Source: WSJ.com: Health - June 10, 2015 Category: Pharmaceuticals Tags: PAID Source Type: news

TransEnterix opens $50m follow-on funding round
TransEnterix (NYSE:TRXC) said yesterday that it’s looking for $50 million from a follow-on offering of common stock to finance the sales and marketing of its SurgiBot robot-assisted surgery device. The Research Triangle Park, N.C.-based company has not yet revealed the amount of shares, share price or date the offering will open. Stifel and RBC Capital Markets will be book-runners on the offering, with Raymond James and BTIG as co-managers, TransEnterix said. The offering comes a week after TransEnterix announced it submitted an application for 501(k) clearance of its SurgiBot system. TransEnterix clai...
Source: Mass Device - June 9, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Funding Roundup Robot-Assisted Surgery Robotics TransEnterix Source Type: news

TransEnterix submits 510(k) application for Surgibot System
TransEnterix (NYSE:TRXC) said yesterday that it submitted an application for 510(k) clearance from the FDA for its SurgiBot robot-assisted surgery device. Research Triangle Park, N.C.-based TransEnterix claims the SurgiBot as the 1st patient-side robotically enhanced laparoscopy platform, designed to be wheeled to a patient’s bedside. "TransEnterix is pleased to deliver on our commitment to file […] The post TransEnterix submits 510(k) application for Surgibot System appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 2, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Robot-Assisted Surgery 510(k) SafeStitch Medical TransEnterix Source Type: news

TransEnterix Submits 510(k) Application to FDA for SurgiBot System
First Patient-Side Robotically Enhanced Laparoscopic Surgery Platform RESEARCH TRIANGLE PARK, N.C.--(Healthcare Sales & Marketing Network)--TransEnterix, Inc. (NYSE MKT:TRXC), a medical device company that is pioneering the use of robotics and flexible ... Devices, Surgery, FDATransEnterix, SurgiBot, laparoscopy (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 1, 2015 Category: Pharmaceuticals Source Type: news

Laparoscopic Left Lateral Sectionectomy in Living DonorsLaparoscopic Left Lateral Sectionectomy in Living Donors
Is laparoscopic surgery for live liver donation a safe and feasible method for liver retrieval? Annals of Surgery (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - June 1, 2015 Category: Consumer Health News Tags: General Surgery Journal Article Source Type: news