Novel CleanCision™ Wound Retraction system won FDA clearance for its abdominal wound Retraction and Protection System

Prescient Surgical, Inc., a medical device innovator based in San Carlos, California  just won FDA clearance for commercializing its novel CleanCision wound retraction and protection system.

This system is one of its kind, advanced surgical protection system designed by surgeons and infection control specialists. It is used by surgeons during abdominal surgery to retract the surgical incision, providing easy access to the surgical site while protecting the edges with an impermeable barrier thereby reducing the chances of wound infection. 

The device is placed in the wound and pulled apart, to open the radial fan like expanding system that is suitable for incisions ranging from 7-16 cm. The wound edges are continuously irrigated by an irrigant fluid of surgeon’s choice with the help of gravitational force from an external fluid bag and the excess is drained via a suction connected to the device. The impermeable inner layer of retractor prevents the wound contamination by fluids in the operative field.

Studies have shown a 61% reduction in rates of SSI using this device. The product is initially promoted for abdominal surgery and particularly colorectal surgery, where the risk, frequency and severity of surgical site infection is high, and the need is acute. But, it is useful in other specialties like Oncology and Ob/Gyn also.

The clearance could not have come at better time because "Hospitals are increasingly focusing on infection control to improve patient care as a primary goal. Prescient's success with the CleanCision device bodes well for providers driven towards the 'triple aim' of quality of care, patient satisfaction, and reduced costs," says Brant Heise, Managing Director at Summation Health Ventures.

The 2016 Surgical Site Infection updated guidelines, published by the American College of Surgeons and Surgical Infection Society, report that the risk of SSI is generally 2 to 5 percent with an estimated 160,000 to 300,000 SSIs occurring annually in the U.S.² The rate of SSI can be as high as 15 to 30 percent in certain high-risk, clean-contaminated, and contaminated procedures such as colorectal surgery.³ National focus on SSI is increasing due to public reporting of surgical site infection rates and significant financial penalties imposed on hospitals, brought about by the Centers for Medicare and Medicaid Service's (CMS) Hospital-Acquired Condition Reduction Program.

Product information

Prescient Surgical News Release

MAP healthwatch: Watch that monitors, analyze and predict your health status

Since the first wave of wearables hit the market, everyone is excited about the impact these devices have on improving the healthcare industry. We have seen Fitbits, Jawbones and others in the market but, these were not medical device and clinicians knew that a break is yet to come.

Well, MAP healthwatch is about to hit the market soon. MAP watch is a medical sensor that is CE and FDA certified that continuously analyze 7 vital parameters that can most commonly predict life threatening diseases. The watch has 5 separate sensors that measures blood pressure, ECG, Heart rate variability, blood oxygen levels, skin temperature, stress and galvanic skin response.

The sensors include PPG sensor with 2 different color LED, 4 contact ECG (Einthoven I lead), Skin conductivity, Skin temperature and 3-axis accelerometer.

MAP was designed, invented and tested by a group of dedicated doctors, engineers and designers from all across the globe.

Each watch is personalized to individual needs. The medical team records the personal medical history, risk factors and inputs the data to customize the watch. Your vital data is continuously recorded on a secure server and evaluated based on medical algorithms. A team of doctors will analyze the data and the person gets regular advice about medical and lifestyle management to lead a healthier life.

This is giant leap of technology on the “life alert” and “cardiac sensors” wearables that are in the market currently.

The watch has a panic button to deal with any kind of medical emergency, if the wearer presses the button he gets assisted by a medical team 24/7.

There is a mobile app for MAP and is compatible with Android and iOS platform.

Being a medical device has not compromised the look of the MAP watch. It’s very aesthetically designed and can be worn every day as a regular watch. It comes is several different colors and available in man and woman size. Its battery lasts for 24 hours without recharging in between.

It can also be worn during any of the fitness activity and will track and monitor the necessary data.

MAP is currently available on preorder and it will hit the regular market in a week.

http://maphealthwatch.com/

Ethicon launches ProxiSure Suturing Device, improving precision in Minimal Invasive Surgery

Ethicon, part of the Johnson & Johnson Medical Devices Companies, announced today the U.S. launch of the ProxiSure™ Suturing Device, an advanced laparoscopic suturing device armed with Ethicon endomechanical, suture and curved needle technologies.

ProxiSure Suturing Device boasts wrist-like maneuverability and curved needle suitable for operating in tight spaces giving surgeons confidence similar to open surgeries. The suturing precision and ease is achieved because surgeons can reach the desired angle, control bites and and secure knots, with having maximum control of the needle during suturing and knot tying all along.

Dr. Niels-Derrek Schmitz, Franchise Medical Director for Ethicon said, "With the patient's health at the forefront of our thinking, we aimed to introduce a suturing device that will help reduce the margin of error in minimally-invasive surgery. Surgeons will now be able to have the same confidence in laparoscopic suturing that they have always had with traditional procedures using Ethicon products."

"Versatility is the key," said Dr. Schmitz. "ProxiSure enables surgeons to do a wide range of tasks in the OR while maintaining an immensely user-friendly configuration." 

ProxiSure Suturing Device is suitable for use in gynecological procedures, bariatric, general and colorectal surgeries, enabling the surgeon to suture a variety of tissue layers, including flat surfaces.

                                    PROXISURE™ Suturing Device In-Service

Media Courtesy: Ethicon.

Wow, new paper based test can tell your blood group in 30 seconds!

Researchers working at the Third Military Medical University in Chongqing, China have developed a quick and reliable test to know the blood type in seconds and rapidly determine the compatibility of donor and recipient blood samples before transfusion.

A conventional test take 10 or 20 minutes to verify someone’s blood type which is the reason why most emergency departments stock only type O blood, which can safely be given to anyone because it lacks the antigens that trigger immune reactions.

Zhang et al test is paper based and relies on the color changes that occur when immobilized antibodies and bromocresol green dye (BCG) react with blood components resulting in color changes that can be readout visually by naked eyes. The paper was published in Science Translational Medicine on 15 March 2017.

Rapid and accurate blood typing is a key component of managing medical emergencies especially in ER and trauma centers. It has the ability to save lives because of saving precious time and avoiding incompatible blood transfusion.

The rapid test gets over the many longstanding problems of older tests like requiring sophisticated instruments, lengthy procedure, requiring expertise and time consuming.

The test is based on the ability of human serum albumin (HSA) to react with the yellow monoanionic dye bromocresol green (BCG) which results in teal BCG-HSA complex in an acidic environment, whereas whole blood produces a brown complex after reacting with BCG, which is easily distinguished with the naked eye.

The test simultaneously performs both F&R tests using a single POC chip, forward grouping identifies specific antigens on RBCs, whereas reverse grouping detects antibodies in plasma on the basis of RBC agglutination. F&R tests are widely used before matching donor and recipient blood before blood transfusion.   

Schematic of the fast blood-grouping devices
Designs, testing procedures, and results of our (A) ABO forward strip, (B) F&R assay, and (C) ABO and Rh group multiplex antigen assays. I and II represent the forward blood-grouping observation windows; III and IV represent the reverse blood-grouping observation windows. The observation zone is located between the two dotted lines as shown in the platforms of the ABO and Rh group assays (C). A strip without antibody (BCG only) was used for quality control (Q)

Using the BCG bio sensing mechanism, the authors developed three test formats to meet various clinical situations: a fast ABO forward and ABD (ABO and Rh D) test for emergency use, an ABO F&R format and an ABO/Rh format (A/B/D/C/c/E/e) for routine clinical tests, and a rare group format for specialized applications.

For quick blood grouping 15 μl of fresh or anticoagulated whole blood was dropped onto the sample zone and incubated for 20 s to allow all specific RBCs to bind to the immobilized specific IgM antibody. Then, 30 μl of elution buffer was introduced to elute the nonagglutinated RBCs and plasma, followed by a color change in the detection zone within 30 s. F&R assay and ABO/Rh group assay required a little more blood and 2 minutes’ time.

The team performed the test on 3550 human blood samples, the strip was more than 99.9% accurate, and only took 30 seconds to complete.

A machine learning method was developed to eliminate the human error and get consistent results and reproducibility by reading the colorimetric assay readouts.

When commercially available it can be of use in resource limited areas, war zones and in emergencies where seconds also matter to save lives. It can be of developed into cost effective universal blood grouping method. 

The full article titled " A dye-assisted paper-based point-of-care assay for fast and reliable blood grouping"  in Science Translational Medicine.

Slimmest wrist blood pressure monitor wearable like a wristband and smart watch in the market soon!

Project Zero 2.0

Monitoring your blood pressure continuously just got easy and stylish with the unveiling of new blood pressure monitor by Omron Healthcare, Inc., the market leader in heart health and wellness technology at the Consumer Electronic Show (CES) 2017 at Las Vegas.

Courtesy: Omron 

The monitor is called Project Zero 2.0, it monitors the blood pressure with clinical precision and tracks physical activity and sleep pattern.

The monitor incorporates a slim, inflatable cuff sensing system and steel micro threads in the wrist band. It just looks like a large smartwatch. The device can also remind you of taking your medication on time.

Just like a smart watch.

Two other B.P. monitors were also shown off at the show as part of Project Zero 2.0. One is ‘Evolve’ a wireless upper arm monitor and ‘HeartVue’ the smallest monitor Omron has made.

All the Omron monitors sync with the Omron app, which displays the B.P. readings and other data like BMI, fat content and physical activity pattern.  Users can share that data directly with their healthcare provider.

The device is powered by rechargeable battery that last a week when fully charged.

Omron President and CEO Ranndy Kellogg said “Omron continues to evolve the experience of checking your blood pressure with technology that is increasingly more portable, more mobile, more connected and easier to use. Checking your blood pressure only in a doctor's office or in a machine at a pharmacy has been redefined by convenient clinically-accurate Omron personal medical devices that can be used at home, at work or on the go.” He further added “We are revolutionizing personal heart health technology to encourage behavior that we know can save lives."

Omron Healthcare recently announced its goal: Going for Zero heart attacks and strokes and Project Zero 2.0 is an important stride in that direction. A massive education and awareness campaign has already been launched by Omron in that respect. For every visitor that checks in at the Omron booth at CES, Omron donates a Blood Pressure Monitor to American Heart Association to be distributed in the community. 

The device is expected to hit the US market in Spring 2017 and is expected to be priced at $ 300.

Sources:

http://www.prnewswire.com/

Omron healthcare

CES 2017