App-t Development for Next Generation Healthcare

App-t Development for Next Generation Healthcare

Sean Fenske, Editor-in-Chief

I am a recent addition to the “smartphone revolution.” While I never doubted the usefulness of these devices, I was simply steadfast in holding out for a reduction in data rates. I figured that with more users adopting smartphones, eventually, providers would reduce rates to get the rest of us who were waiting for a more affordable plan to hop aboard the bandwagon.

Finally realizing that this was unlikely to happen anytime soon, I folded (like a cheap suit…) and signed a new contract for a brand new, shiny Samsung Galaxy. The many advantages simply outweigh the cost concerns I had, and every couple of days, it seems I find a new benefit to having the device that I hadn’t even realized might be useful.

One of the offerings that many smartphone users have explored are the medical/healthcare apps. Whether using them for monitoring of vital signs during an exercise routine or tracking calories for a weight-loss program, these apps are becoming a daily touch point for users and their health. If nothing else, it keeps them conscious of their well-being, and that alone has to be considered a benefit.

What I’ve also come to realize is that any company developing such an app (whether it be healthcare related or not) has many more concerns to address beyond the general usefulness of their offering.

One of the first things I was shocked to find with my smartphone was how quickly the battery drained. Granted, much of that is due to the large screen, but since I was able to specifically delve into the battery “report” and see what was using up my power the most, I suddenly became very selective in which apps I allowed to run on the device (as much as I could anyway). Anything that I wasn’t using at all was immediately shut down completely or uninstalled. Any app I download that shows up on this power “report” page better be truly worthwhile or it’s likely to get the boot.

Just as power is a concern for mobile medical device developers, power consumption has to be on the minds of any designers of healthcare apps. If using the app results in having to charge the phone more often, users are going to get frustrated and stop using it. If they feel the need to plug the phone in while the app is in use, they’ve completely eliminated the purpose of having an app on a mobile phone to accomplish the task.

Additionally, since my plan provides me with a fixed amount of data, that report also went on my “watch list.” I set up alerts to let me know when I get too close to my limit and have a hard stop set up to prevent charges should that limit be reached.

Again, developers need to address how often data is sent and the size of the data packet so as to not seem like a burden for the user. And I found that apps that used significant data while not being put into active use by me were more “offensive” than those that only broadcast data when I had the program open. If data needs to be transmitted at fixed times – regardless of whether the user has the app open or not – perhaps allowing the user control over that would alleviate any concerns of data being sent when the person is not using the app actively.

These issues are nothing new to medical device manufacturers who are developing standalone, mobile healthcare technologies. Addressing data transmission and power consumption is something they have been dealing with long before smartphones and apps were offered. However, given that those devices are typically serving one purpose (i.e., the medical application), designers need not be concerned with the user’s impression of these factors (power consumption and data transmission) since the user is likely not monitoring them as closely as they are with apps on a smartphone. Sure, developers certainly need to optimize these elements, but it’s unlikely the user is going to form an opinion based around them.

When it comes to app development in the healthcare space, there are an array of other considerations designers need to keep in mind. FDA oversight, the use of accessories and connectivity with them, aesthetics, and usability are all additional and very relevant factors that need to be addressed. This likely would ensure continued usage of an app. Any one of these design elements can derail user adoption and kill an app. But these are true of most other medical devices being used in home healthcare today. The user’s perception of a medical app based on data transmission and/or power consumption is fairly unique to medical device apps and something developers certainly need to keep at the forefront of their minds.

 

 

Blue Ocean Medical Product is the fastest leading FDA 510K consultant in the US. The company will be your partner throughout the FDA 510K Submission process.

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Silver dressings used with NPWT shown to reduce staph infection bacterial load

Silver dressings used with NPWT shown to reduce staph infection bacterial load

Complex wounds, Infection

Silver dressings used with NPWT shown to reduce staph infection bacterial loadIn a recent study, silver dressings used in conjunction with negative pressure wound therapy (NPWT) have been shown to significantly decrease bacterial loads in wounds, specifically ones contaminated with Pseudomonas aeruginosa or Staphylococcus aureus.

 

Researchers writing for the Journal of Trauma-Injury Infection & Critical Care have recently found that the bacterial load of wounds inoculated with Pseudomonas aeruginosa or Staphylococcus aureus was approximately 20% less when using silver dressings with NPWT, compared with the NPWT control group without the use of silver. Six hours after inoculation, researchers debrided the wounds and covered them with silver-infused gauze. The wounds were then debrided every 48 hours for a total of six days.

 

In the wounds inoculated with P. Aeruginosa, the group using silver dressings with NPWT contained 21% bacteria, while the control group contained 43%, thus showing the benefits of silver-containing dressings used with NPWT.

 

read the whole article here: http://www.woundsinternational.com/news/silver-dressings-used-with-npwt-shown-to-reduce-staph-infection-bacterial-load/page-1

 

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US FDA grants marketing approval to Syneron Medical’s UltraShape System for fat cell destruction

US FDA grants marketing approval to Syneron Medical’s UltraShape System for fat cell destruction

Irvine, California
Wednesday, April 16, 2014, 18:00 Hrs  [IST]

Syneron Medical Ltd., a global market leader in the aesthetic medical device marketplace, has received the United States Food and Drug Administration (FDA) 510(k) clearance to market the UltraShape System for non-invasive reduction of abdominal circumference via fat cell destruction.

The UltraShape System is the first and only non-invasive body shaping treatment that uses pulsed focused ultrasound energy that precisely targets subcutaneous fat, while keeping the surrounding tissue, vasculature, nerves and muscles intact. Unlike other body shaping technologies, UltraShape uses a pure mechanical effect to destroy fat cells without inducing thermal damage. This unique feature of the UltraShape technology results in a safe and comfortable treatment experience.

“The UltraShape technology is one of the two pillars of our body shaping strategy,” stated Shimon Eckhouse, active chairman of the board of directors of Syneron. “Our significant investment in the development of non-invasive body shaping products puts us in a unique position to lead the market with UltraShape mechanical fat destruction technology, and with our unique VelaShape III elos based thermal technology. With these two FDA cleared technologies we have a wide range of body shaping indications including circumferential reduction in various body areas and reduction in cellulite appearance. These two complementary technologies will be key factors for serving our global customer base in the fast growing body shaping market.”  Dr. Eckhouse concluded: “Our investment in the UltraShape technology of over two years resulted in a clear demonstration of the unique clinical value of this technology for safe and comfortable non-invasive fat destruction.”

“The unique set of features of this technology and the high level of consumer interest in non-invasive body shaping based on direct fat destruction, create a very important opportunity for Syneron to significantly enhance not only its capital equipment sales but also the recurring revenue part of its business,” stated Amit Meridor, Syneron’s CEO. “We plan to limit the highly anticipated initial launch of UltraShape in the US in 2014 to a select list of key opinion leaders in aesthetic medicine. This initial launch phase will enable us to fully develop our recurring revenue part of the business which we plan to combine with account managers that will support the business needs of our customers. In parallel to the US effort we plan to gradually implement similar models in international markets, in which the lack of FDA clearance of the technology was a drawback to its growth. We expect to see the full impact of this effort in 2015,” concluded  Meridor.

“UltraShape is a nonsurgical device that precisely delivers focused ultrasound energy strong enough to destroy fat cells while leaving neighboring tissue unharmed. The benefit of UltraShape is that each treatment can be customized to the individual patient. UltraShape uses non thermal ultrasound providing efficacy and the non-heat dependent energy is tolerated well by the patients,” said Jeffrey M Kenkel, MD, FACS, Professor and vice chairman of the Department of Plastic Surgery at the University of Texas Southwestern Medical Center at Dallas, one of the primary investigators in the multi-center IDE study.

In the randomized, controlled clinical study of UltraShape which was performed at three clinical sites in the US and one site outside of the U.S., a total of 150 subjects were treated and followed for up to four months. In this multi-site study, patients demonstrated an average reduction of 2.5 cm in the treatment phase and 0.5 cm reduction in the control phase.

“We observed clinically significant circumference reduction of truncal fat. The results demonstrated progressive improvement over time in circumference reduction, beginning after the first treatment session with UltraShape. The treatment was administered without the need for anesthetic and was well tolerated by patients. No serious adverse events were reported,” stated William Coleman M.D., Clinical Professor of Dermatology, Adjunct Professor of Surgery (Plastic Surgery), Tulane University Health Sciences Center and a principal investigator in the study. “In our practice, patients were very satisfied with the results of the UltraShape treatment.”

The UltraShape System received CE mark in 2005 and is marketed in European countries, Canada, and Asia Pacific countries. The device has been used in over 220,000 procedures worldwide, with a positive safety and effectiveness profile. Syneron acquired UltraShape in March 2012. Since the acquisition, Syneron’s main focus has been to gain FDA regulatory clearance for the system in the United States, which opens a significant market opportunity for the product and provides important validation for potential customers around the world.

Blue Ocean Medical Products is the faster growing FDA 510K consultant in the US market. “We’ve been helping a lot of medical start up with their 510K submissions”.

PR news fro Pharmabiz.com : http://www.pharmabiz.com/NewsDetails.aspx?aid=81435&sid=2

Equinox Medical’s How to use their NPWT BLack Foam Dressing Kits

UNI NPWT BLACK FOAM DRESSING KIT APPLICATION

uni black foam npwt kit

The UNI NPWT black foam kit includes the following:

  • Black Foam
  • Dome Pad and tubing
  • 1,2,3 Drape
  • *ask for adapter if needed

Picture

Supplies Needed:

  • Gloves
  • Sterile Normal Saline
  • Sterile Gauze
  • Scissors
  • Protective Barrier Wipes/Skin Prep

Picture

1. Assess wound and determine if appropriate for NPWT. Assess wound with every dressing change.
2. Wound measurement should be  performed and documented per  facility protocol. Usually once per week.
3. Wound Prep: Per facility protocol. Be sure to efficiently irrigate wound to remove any foam  fragments.

skin prep before black foam dressing change

4. Apply protective barrier (skin prep, additional transparent drape) to protect the  peri-wound. (Per facility protocol)
5. The protective barrier will add protection to intact skin and promote greater adherence of transparent drape.

6. Open Uni NPWT black foam dressing kit and scissors on a clean and dry surface.
7. Cut the black foam to the size/shape of the wound dimensions. For shallow wound, foam may need to be “filleted” (decrease depth to foam) to fit appropriately.
8. Do not cut the black foam over the wound as small fragments may fall into the wound bed. Brush off before  inserting into wound bed.
9. Dressing size should allow for the dressing to fill wound cavity without overlapping on the intact skin.

uni black foam dressing on the wound

10. Gently place the foam dressing into the wound cavity, covering the entire wound bed.
11. Do not force or forcefully push in the foam dressing. Potential damage to the wound may occur. NOTE: White foam should be utilized for tunneling and undermining.

npwt drape and black foam dressing kit

12. Size and trim the transparent to cover the foam dressing. Cut a nickel size hole   into the center of the drape.
DO NOT CUT A SLIT, CUT A HOLE. HINT: Fold the transparent
13. The 1,2,3 step drape was designed to provide easy drape application.
14. Proper drape application is the key to a good seal.

peel off NPWT 1,2,3 drape

15 Peel off tab #1 first
16. Center the CUT hole over the center of the black foam.

Picture

17. Gently press down the expose adhesive to the skin.
18. Gently press the top of the drape to ensure adhesive contact to the skin.
19. Do not rush or forcefully push the drape.

20. Peel off tab #2 which peels off at the ends and underneath; gently press the drape around the peri-wound and work your way out to the edges of the drape.
21. Do not compress foam dressing while applying the drape.
22. Look for any areas where there are potential loss of seal, such as any contour surfaces. Have the drape follow the curves.

Picture

23. Before you feel of tab #3, make sure to form a proper seal.
24. When proper seal is secured completely remove tab #3.

Picture

25. Apply the dome pad by removing the back liner and then placing the center of the pad directly over the cut hole in the transparent drape.
26. Position the tubing appropriately as you place the dome. The tubing will need to be anchored so as not to pull at the dressing causing a loss of seal later.

npwt black foam dressing kits and npwt dome pad

27. Make sure to properly align the dome pad to the center hole.
28. If the dome is not aligned, the negative pressure will not reach the wound.
29. Make sure to properly seal the dome pad adhesive to the top of the drape.
30. Always check for an air-tight seal ensuring there are no leaks in the drape.

Picture

31. Once a proper air-tight seal has been accomplished, peel off the back liner.
32. Peel off the “Blue Tabs”
33. Pat around the dome pad to ensure complete adhesion.

34. Be sure to anchor your tubing.
35. Connect the adapter tubing to the end of the dome pad tubing.
HINT: an adapter is required to connect the dome pad connector to the NPWT pump without adapters.
36. There are different adapters available for different types of NPWT pump systems.
HINT: Always let your sales person what model of NPWT pump you are using to make sure you get the proper adapters with your UNI NPWT black foam dressing kits.
Equinox Medical, LLC is a leading NPWT Pump and Universal NPWT Black Foam dressing kits in the wound care market.Click here for a NPWT Sample

FDA Allows Novel Battlefield Wound Treatment to Be Marketed

FDA Allows Novel Battlefield Wound Treatment to Be Marketed

  • Apr 09, 2014

The U.S. Food and Drug Administration recently announced it has allowed the marketing of an expandable, multi-sponge wound dressing for controlling bleeding from certain types of battlefield wounds. The XSTAT is manufactured by RevMedX, Inc., in Wilsonville, Ore., and is for military use only as a temporary dressing for wounds in areas where a tourniquet cannot be placed, such as the groin or armpit. XSTAT can be used up to four hours, which could allow time for the patient to receive surgical care, according to FDA.

FDA’s announcement said XSTAT was reviewed through FDA’s de novo classification process for novel, low- to moderate-risk medical devices that are first-of-a-kind.

The agency cited the U.S. Army Medical Department, Medical Research and Materiel Command as the source for data showing that, since mid-World War II, nearly 50 percent of combat deaths have been due to bleeding out. “Of those, half could likely have been saved if timely, appropriate care had been available,” it states.

The XSTAT device consists of three syringe-style applicators containing 92 compressed cellulose sponges that have an absorbent coating. “The sponges expand and swell to fill the wound cavity, after approximately 20 seconds upon contact with water from blood or bodily fluid. This creates a temporary physical barrier to blood flow. The number of sponges needed for effective hemorrhage control will vary depending on the size and depth of the wound. Up to three applicators may be used on a patient. The tablet-shaped sponges are each 9.8 millimeters in diameter and 4 to 5 millimeters in height. They can absorb 3 milliliters of blood or body fluid. An applicator filled with 92 sponges, therefore, can absorb about 300 milliliters of fluid. The sponges cannot be absorbed by the body and all sponges must be removed from the body before a wound is closed. For ease of visualization and to confirm removal of every sponge, each sponge contains a marker visible via X-ray,” according to the announcement.

 

“XSTAT is a novel device that can be rapidly deployed, providing fast-acting hemorrhage control to stabilize a wounded patient for transport. This will be an important new treatment option for our nation’s military to treat injured soldiers who may not be in close proximity to a medical facility,” said Christy Foreman, director of the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health.

 

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Genadyne NPWT pump had contaminated exudate inside the pump housing

GENADYNE A4 NEGATIVE PRESSURE WOUND THERAPY A4

Adverse Event reported on 11/12/2013

Device Attributes
Attribute Value
Manufacturer GENADYNE BIOTECHNOLOGIES, INC.
Brand Name GENADYNE A4 NEGATIVE PRESSURE WOUND THERAPY
Device Type NEGATIVE PRESSURE WOUND THERAPY
Product Code OMP
Model Number A4
Catalog Number
Device Operator 0HP
GENADYNE BIOTECHNOLOGIES, INC. GENADYNE A4 NEGATIVE PRESSURE WOUND THERAPY   Back to Search Results
Model Number A4
Event Date 09/18/2013
Event Type  Injury   Patient Outcome  Other,Required Intervention
Event Description
On (b)(4), a hospital’s biomedical engineering department received a genadyne wound therapy unit from hospital staff to repair as it was not able to be turned on. Upon assessment, biomedical engineering staff identified the genadyne unit to be “heavily contaminated by biological waste. ” this waste had made it through all internal mechanisms including the pump and other components causing device malfunction. This contamination was on the interior of the unit where it was not visible to clinical staff members. This unit was removed from the inventory and disposed of as contaminated. On (b)(6), a second unit was sent from the floor to biomedical engineering. When the case was opened, it had the same visible evidence of having biological waste in the tubing, pump and components. With two units exhibiting the same problem, a determination was made that a time line could not be established for when the biological contamination occurred to the inside of the units and all units could be potentially affected. The hospital took immediate action by removing all the genadyne wound vacuum systems from service. Genadyne was promptly contacted and they stated that the device malfunction was due to improper preventive maintenance of the units. However, the genadyne a4 negative pressure wound therapy user manual/technical manual does not contain any maintenance procedures or reference any maintenance is required. Furthermore, there is no indication in the manufacturer’s instructions for any cleaning of any internal components within the power casing unit. It does, however, state several times throughout the manual as well as labeled on the device not to attempt to open the unit as it is not serviceable. When further inquiries were made to genadyne, the manufacturer stated the message of their maintenance requirement “is often conveyed during the point of sale as well as free technical training. ” neither was provided to this hospital. Additionally, the manufacturer acknowledged that there is a potential for cross-contamination. We strongly believe that genadyne is not complying with regulatory requirements for medical devices and that these devices pose a risk to the safety of pts.http://fdazilla.com/maude/adverseevent/3476549

 

npwt pump in wound care

NPWT Pump by Equinox Medical

Can you give me some guidelines regarding when I should start negative pressure wound therapy and when it should be discontinued?

Negative pressure wound therapy (NPWT) is a progressed wound dressing that applies subatmospheric pressure to the wound couch. It pushes and quickens wound mending.

In the first place, survey the wound quaint little inn the status of the tissue in it. Does it seem sound with soggy, red granulation tissue? What rate of it is secured with granulation tissue?

Obviously, wound mending may happen all the more quickly if the wound couch is secured with 100% sound granulation tissue.

Note the measure of necrotic tissue, for example, quagmire or eschar, coating the wound couch. NPWT is not a debridement measure. Contingent upon the measure of necrotic tissue, other debridement strategies may be the best medicine alternative before provision of NPWT.

The greatest measure of eschar in the wound bunk upon requisition of NPWT ought to be resolved dependent upon suggestion from the producer, clinical rules and the office or org conventions.

The point when ought to NPWT be ended? After the wound bunk is loaded with sound granulation tissue and the seepage is reduced. Epithelization is the following period of wound mending. Numerous clinicians stop NPWT at this point.

In view of wound recuperating appraisal, if no mending has been noted or if the wound continues as before following two to three weeks, the wound forethought administration ought to be re-assessed. This could incorporate a change in the topical wound medicine, including end of negative pressure wound therapy.

Opportune expansion or suspension of NPWT dependent upon the status of wound mending is key for the procurement of value, practical wound forethought.

 

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7 Day NPWT Pump Trial by Equinox Medical, LLC

Equinox Medical, LLC is presently offering a 7 day free NPWT Pump trial at no charge. The organization will send you a specimen of NPWT dark froth dressing, Halo XT or Halo XP NPWT Pump and ultimately NPWT White Foam dressing. The organization chose its an incredible thought for merchants to see and play around with the items before buying the item. Basically, you test drive the pump before you purchase it. Equinox Medical, LLC is working truly hard in preparing inventive items to help there accomplices contend with the wound forethought market. As we all know, the business sector pioneers have 70 to 80 percent of the piece of the pie in the wound forethought field. They simply feel committed to help little organizations to contend and level the playing field a tad bit.

In the event that you are intrigued on trialing any of Equinox Medical NPWT Pumps. Click on the connection underneath:

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POST FROM FDAZILLA.com: Genadyne A4 NPWT Pump is heavily contaminated with exudate inside the motherboard

GENADYNE BIOTECHNOLOGIES, INC. GENADYNE A4 NEGATIVE PRESSURE WOUND THERAPY  
Model Number A4
Event Date 09/18/2013
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
On (b)(6), a hospital’s biomedical engineering department received a genadyne wound therapy unit from hospital staff to repair as it was not able to be turned on. Upon assessment biomedical engineering staff identified the genadyne unit to be “heavily contaminated by biological waste. ” this waste had made it through all internal mechanisms including the pump and other components causing device malfunction. This contamination was on the interior of the unit where it was not visible to clinical staff members. This unit was removed from the inventory and disposed of as contaminated. On (b)(6), a second unit was sent from the floor to biomedical engineering. When the case was opened it had the same visible evidence of having biological waste in the tubing, pump and components. With two units exhibiting the same problem a determination was made that a time line could not be established for when the biological contamination occurred to the inside of the units and all units could be potentially affected. The hospital took immediate action by removing all the genadyne wound vacuum systems from service. Genadyne was promptly contacted and they stated that the device malfunction was due to improper preventative maintenance of the units. However, the genadyne a4 negative pressure wound therapy user manual/technical manual does not contain any maintenance procedures or reference any maintenance is required. Furthermore, there is no indication in the mfr’s instructions for any cleaning of any internal components within the power casing unit. It does, however, state several times throughout the manual as well as labeled on the device not to attempt to open the unit as it is not serviceable. When further inquiries were made to genadyne, the mfr stated the message of their maintenance requirement “is often conveyed during the point of sale as well as free technical training. ” neither was provided to this hospital. Additionally, the mfr acknowledged that there is a potential for cross-contamination. We strongly believe that genadyne is not complying with the regulatory requirements for medical devices and that these devices post a risk to the safety of patients.Image

information was taken from http://fdazilla.com/maude/adverseevent/3476512

 

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Spiracur Announces FDA Clearance

Spiracur Announces FDA Clearance of Its SNaP Wound Care System Dressings With Hyperbaric Oxygen Therapy

 

 

SUNNYVALE, CA–(Marketwired – Apr 1, 2014) – Spiracur today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the SNaP® Wound Care Dressing (with fittings and cartridge removed) for use in a hyperbaric oxygen therapy (HBOT) chamber for the treatment of chronic wounds. Spiracur develops the only mechanically powered advanced wound care solution that delivers the proven efficacy of Negative Pressure Wound Therapy (NPWT).

“At the O’Connor Wound Care Clinic, we utilize the latest and some of the most advanced treatment options including whole body HBOT for our patients who have wounds that won’t heal because of diabetes or other health conditions,” said Bruce Lerman, D.P.M., O’Connor Hospital, San Jose, Calif. “In fact, we just began using the ultraportable SNaP Dressing products with HBOT, as they are my first choice for NPWT, and the combination of the two therapies is proving to be a very effective treatment option for chronic, non-healing ulcers.”

HBOT is the medical use of oxygen, which involves the breathing of pure oxygen while in a sealed chamber that has been pressurized at one-and-a-half to three times normal atmospheric pressure. A well-established treatment for decompression sickness, HBOT is also used to treat severe carbon monoxide poisoning; certain kinds of wounds, injuries and skin infections; delayed radiation injuries; and certain bone or brain infections1.

“We are very pleased that SNaP Dressings are now able to remain in place while patients undergo HBOT for chronic wound treatment such as diabetic foot ulcers,” said Linda LaMagna, vice president of global marketing for Spiracur. “Because the SNaP Dressings are cleared for use within a HBOT chamber, our SNaP System is a smart and convenient choice for wound care clinics looking for an advanced NPWT solution that is proven to be effective, safe for patients, and reimbursable by Medicare.”

Spiracur is credited with creating a new category of chronic and acute wound management solutions that combine the benefits of advanced wound care with non-powered NPWT. The SNaP (Smart Negative Pressure®) System provides patients with a sophisticated, non-invasive NPWT system designed to promote wound healing, which weighs only 2.2 ounces and does not require batteries or electricity.

Spiracur’s suite of products cleared by the FDA for use with HBOT include the SNaP Dressing Kit, a proprietary hydrocolloid dressing offering periwound protection and easy removal; the SNaP Bridge Dressing, a soft dressing with pressure points displaced away from the wound to minimize further pressure damage; the BLUE foam interface layer, which helps promote granulation tissue formation and may improve visualization of exudate; and the SNaP SecurRing® Hydrocolloid, a soft and moldable hydrocolloid that is designed to enable fast and easy sealing on uneven skin surfaces and wounds in challenging locations.

About Spiracur Inc.
Spiracur Inc., headquartered in Sunnyvale, Calif., is a privately held medical device company focused on the development of innovative wound healing technologies. Spiracur was founded out of the Stanford University Biodesign Innovation Program in 2007. Its first product, the SNaP Wound Care System for the treatment of chronic and acute wounds, is the result of patient and clinician feedback that current negative pressure wound therapies were too cumbersome. The company’s ciSNaP® Closed Incision System with proprietary controlled tension relief is designed to improve healing of high-risk surgical incisions. Both devices have received 510(k) clearance from the U.S. Food & Drug Administration (FDA) and have received CE Mark approval. Spiracur’s proprietary mechanically powered technology does not require batteries or electricity to operate. For more information, please visit http://spiracur.com.

Spiracur, Spiracur logo, SNaP, SNaP & Design, Smart Negative Pressure, SecurRing and ciSNaP are registered trademarks of Spiracur Inc.

 

 

Blue Ocean Medical Products specialized in a full service of development, design, and production of silicone and plastic injection molded medical products. Our management team has extensive healthcare experience, our capabilities include regulatory management, clinical evaluation coordination, FDA pre-market application, FDA 510K process application, sales, distribution and marketing.

 

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