Robot-assisted surgery is under the spotlight again as one research company claims the adoption of Intuitive Surgical’s daVinci system is riddled with flaws. Citron Research urges intuitive to “stop one-sided and misleading marketing to patients, without full disclosure of the risks”.
Gynaecology/Obstetrics
Real-Time Cervical Neoplasia Detection with Newly CE Marked Zedscan™ I Device
Zilico Ltd has gained CE Mark certification for its cervical cancer diagnostics device, ZedScan™ I. The UK company’s ground-breaking system offers quick, accurate detection of cervical neoplasia in real-time, enabling clinicians to improve patient management.
So, Robots…. Yes or No?
Intuitive Surgical is a beacon for robotic surgery, but it’s not finding it plain sailing in 2013 having faced a number of challenges thus far. Now a new study suggests da Vinci hysterectomy costs more but doesn’t deliver more than conventional surgery.
ExAblate Receives Approval of Health Canada for the Treatment of Uterine Fibroids and Pain Palliation of Bone Metastases
InSightec Ltd, a leader in MR guided Focused Ultrasound therapy, announced that its ExAblate system has received approval of Health Canada for MRgFUS treatment of uterine fibroids and for pain palliation of bone metastases.
CE Mark for The Stork®, “Bringer of Pregnancy”
Intuitively one can imagine a device that delivers semen directly to the cervical opening, might just work. Now that “The Stork” has gained CE mark approval it seems the European authorities buy the story too.
Funding for Transvaginal Mesh Actions Increases In Line With Win Likelihood
Legal-Bay LLC, The Lawsuit Settlement Funding Company, has increased funding amounts for transvaginal mesh and bladder sling cases now that the litigation has progressed into a new phase. That’s a neat way of saying the odds have improved so we’re prepared to up the stake.
ExAblate Receives Approval of Chinese Food and Drug Administration
Non-invasive MR guided Focused Ultrasound treatment now available for millions of Chinese women suffering from uterine fibroids.
American Medical Systems Launches MiniArc™ Pro Single-Incision Sling System for Treatment of Female Stress Urinary Incontinence
American Medical Systems® (AMS), Inc., has announced the U.S. launch of its MiniArc™ Pro single-incision sling system for the treatment of female stress urinary incontinence. The MiniArc Pro is designed with a new visual feedback system that gives the physicians the ability to objectively measure sling tension in a repeatable way to help find the most accurate placement for their patient.
Is Robotic Surgery Just Too Expensive To Go Mainstream?
Preliminary second quarter figures from surgical robotics company Intuitive Surgical, Inc. are some way off the company’s predictions. Q2 projections included sales of over $620M, which would have been a 16%+ ramp, but actual sales came in at $575M, only a 7% increase over prior year.
FDA Warns That Stolen Covidien Stapler Reloads Not Sterile
The FDA has issued a warning to healthcare professionals that stolen Covidien stapler reloads may be in circulation. The reloads are labelled sterile, but were stolen from the company prior to sterilisation taking place.
Technique For Analysing Embryos’ Crucial First Hours Helps Select Most Viable
The UK’s Bourn Hall, the world’s first IVF clinic, is introducing a new technology that captures early embryo development on video and then provides detailed, objective information about size and growth. This information can be used by embryologists to help them decide which embryos have the greatest chance of becoming a baby when transferred to the woman’s womb.
Olympus Claims First Articulating HD 3D Laparoscopic Surgical Video
Olympus claims is fancy pants new 3D HD visualisation system improves speed, accuracy and precision of surgical procedures when compared with 2D surgical systems.
FDA Clears iCAD’s Cervical Applicator For Xoft Electronic Brachytherapy System
iCAD, Inc., has received U.S. FDA clearance for its new cervical applicator for use with its Xoft® Axxent® Electronic Brachytherapy System® to deliver high dose rate brachytherapy for intracavitary treatment of cancer of the uterus, cervix, endometrium and vagina.
FDA 510(K) Clearance for Ethicon Endo’s ENSEAL® G2 Cordless
Ethicon Endo-Surgery, Inc. has announced the 510(k) clearance from the U.S. FDA for its ENSEAL® G2 Cordless Tissue Sealer Device. Already previously approved in a variety of iterations, the new cordless design is clearly pitched at procedures where speed and range of motion may be critical.
UK’s NICE Consults On New Device For Assessing A Pregnancy Complication
The National Institute for Health and Clinical Excellence (NICE) today (20 March), opens a consultation on its draft medical technology guidance on the use of a device to assess the potentially serious complication of unexplained vaginal wetness in pregnancy.
First U.S. Commercial Use Of MIS Uterine Fibroid Treatment
Halt Medical, Inc. announced first commercial Acessa Procedure in the United States. The procedure is used for the treatment of uterine fibroids. Acessa is a minimally invasive laparoscopic procedure that delivers radiofrequency energy to destroy the fibroids.