"The future of surgery is not about blood and guts; the future of surgery is about bits and bytes.”
/Dr. Richard Satava/

Friday, August 26, 2016

Safety and regulatory aspects of the FLEX robot

A recent article in IEEE Spectrum about the FLEX robot featured some interesting thoughts about the current US regulatory environment of surgical robots:
  • "the biggest hassle was ensuring that the robot was dumb enough to meet the U.S. Food and Drug Administration’s (FDA’s) requirements.   
  • “When we approached the FDA, almost the first question out of their mouth was about the autonomous nature of the robot. They raised it as a serious red flag,” says Medrobotics CEO Samuel Straface. “We had to show that the surgeon has complete and absolute control at all times. If it was any other way, we’d still be a science project,” he says.
  • the FDA has barred anything resembling an autonomous robotic assistant from the operation room.
  • If a smarter surgical tool can make a procedure less risky, the FDA may give it approval."
Just wait and see until our IEC/TR60601-4-1: Medical electrical equipment – Part 4-1: Guidance and interpretation– Medical electrical equipment and medical electrical systems employing adegree of autonomy comes out.
Source: IEEE Spectrum

Wednesday, August 24, 2016

Video Wednesday

Not exactly surgery, but may hold interest:

World's First Tattoo by Industrial Robot from Pier 9 on Vimeo.

Monday, August 22, 2016

Avatera - a new robot from Germany

Avateramedical has been developing a new master-slave surgical robot system for many years. After the initial tests with the advanced prototype, it's now ready for publicity!
"Laparoscopic surgery based on a telemanipulator-supported system offers surgeons considerable advantages. Associated ideas and approaches have already existed for a long time. Some robot-assisted surgical procedures, especially in the treatment of prostate and kidney cancer, have almost replaced traditional laparoscopic techniques.  Higher precision, 3D visualization, extended instrument movement capacity, improved ergonomics for the surgeon, fewer complications and shorter hospitalization periods for the patient are what physicians and clinics specify as arguments in deciding for robot-assisted surgery.  We are convinced that this pioneering form of surgery will be used far more extensively if the previously set barriers regarding the purchase and operation of a robotic system can be overcome. This is precisely the challenge we are facing and are therefore developing a highly modern platform for robot-assisted surgery."
The Design Principles of the avatera-System:
Surgical robot
  • 4 robotic arms
  • mobile, light-weight design
  • 5 mm, articulated instruments with 7 degrees of freedom
Control unit
  • more than Full-HD 3D-Visualization
  • open design for close interaction with the surgical team
About the company:
avateramedical GmbH was founded in 2011 at the initiative of leading surgeons, international investors and medical technology experts. Right from the start, it has been our objective to create an attractive system for robot-assisted surgery. Meanwhile, our company has been certified as a provider of medical devices in accordance with ISO 13485. The avatera group is currently employing more than 90 members of staff.
All avateramedical development activities take place in Germany. Our corporate head office is located at the medical technology location Jena/Thuringia."

Avateramedical received €75m convertible loan from ConvEx last summer. Planned commercial launch: 2017. Stay tooned! 

Source: avateramedical

Sunday, August 21, 2016

New hybrid magnetic single-port device

"Levita Magnetics, a medical device start up company based in San Mateo, California, recently debuted a device that they tout as the first magnetic surgical platform to receive CE Mark and FDA clearance.
The Levita Magnetic Surgical System is currently indicated for gallbladder surgeries. Because the system allows the surgeon to magnetically retract and remove the gallbladder, they are able to to perform cholecystectomies without making an incision in the abdominal wall."

Source: Levita MagneticSurgical Products Mag

Friday, August 19, 2016

Titan Medical is seeing difficulties in finance

"More recently, the Company has been notified by its principal development suppliers that they have decided to temporarily suspend development work of the SPORT Surgical System until such time that the Company has sufficient financing to cover current and future work orders projected over a six-month period. As well, the previously announced US $16.0 million equity investment from Shanghai JuGu Equity Investment Fund Co. Ltd. (“Shanghai JuGu”) that was expected to close on June 30, 2016, and was subsequently extended to August 15, 2016, has not closed as of the date hereof. There can be no assurance that the investment from Shanghai JuGu will be completed on the terms previously announced, if at all. The Company’s Board of Directors is exploring strategies to raise financing necessary to allow the Company to resume its development of the SPORT Surgical System. The Company remains committed to accomplishing its next major milestones towards achieving submission of its 510(k) application to the U.S. Food and Drug Administration (“FDA”). However, due to the suspended development work the Company’s milestone and 510(k) submission timeline may need to be revised if the delay extends past the end of August.
The Company’s development process is well-defined and includes completing the development of the technology as well as completing testing that will provide the results that demonstrate substantial equivalence between the SPORT Surgical System and predicate devices. Titan’s management team has worked to identify the predicate devices to which the Company must demonstrate substantial equivalence. The refined timeline to accomplish the remaining milestones incorporates our current and best analysis, as well as input from a variety of sources, to reflect recent developments in the industry. A very meticulous approach to the process is being executed and documented in preparing data for a 510(k) application."

Monday, August 15, 2016

Nanorobots in action

"Researchers from Polytechnique Montréal, Université de Montréal, and McGill University have just achieved a breakthrough in cancer research. They have developed new nanorobotic agents capable of navigating through the bloodstream to administer a drug with precision by specifically targeting the active cancerous cells of tumors. This way of injecting medication ensures the optimal targeting of a tumor and avoids jeopardizing the integrity of organs and surrounding healthy tissues. As a result, the drug dosage that is highly toxic for the human organism could be significantly reduced.  
This scientific breakthrough has just been published in the journal Nature Nanotechnology in an article titled "Magneto-aerotactic bacteria deliver drug-containing nanoliposomes to tumour hypoxic regions." The article notes the results of the research done on mice, which were successfully administered nanorobotic agents into colorectal tumours."
"Oxygen-depleted hypoxic regions in the tumour are generally resistant to therapies1. Although nanocarriers have been used to deliver drugs, the targeting ratios have been very low. Here, we show that the magneto-aerotactic migration behaviour2 of magnetotactic bacteria3, Magnetococcus marinus strain MC-1 (ref. 4), can be used to transport drug-loaded nanoliposomes into hypoxic regions of the tumour. In their natural environment, MC-1 cells, each containing a chain of magnetic iron-oxide nanocrystals5, tend to swim along local magnetic field lines and towards low oxygen concentrations6 based on a two-state aerotactic sensing system2. We show that when MC-1 cells bearing covalently bound drug-containing nanoliposomes were injected near the tumour in severe combined immunodeficient beige mice and magnetically guided, up to 55% of MC-1 cells penetrated into hypoxic regions of HCT116 colorectal xenografts. Approximately 70 drug-loaded nanoliposomes were attached to each MC-1 cell. Our results suggest that harnessing swarms of microorganisms exhibiting magneto-aerotactic behaviour can significantly improve the therapeutic index of various nanocarriers in tumour hypoxic regions."