Repost from Ten Links – 3Shape Implant Studio gets FDA Approval

3Shape Implant Studio Gets FDA Approval

3Shape_logoCOPENHAGEN, Denmark, Nov 24, 2014 - 3Shape, a leading global innovator of digital 3D solutions for dental labs and dental clinics, is proud to announce that the US Food and Drug Administration (FDA) has granted (510k) market clearance for the sale of its Implant Studio software in the USA.

3Shape Implant Studio software merges CT/ Cone Beam CT imaging with 3D digital surface scans of the teeth and gingival situation to provide a digital view of dental patients.

ImplantStudio-FDA-ClearenceThe software then enables dental professionals to evaluate the clinical situation including bone density and nerve positions for creating prosthetic implant planning and surgical guide design.

3Shape Implant Studio is used extensively in Asia, Europe and South America.

“3Shape is very excited about this FDA (510k) market clearance which opens the door to new service options for both clinics and labs in North America. Importantly, as more and more people are choosing dental implants to meet their restoration needs, Implant Studio will enable dental professionals to more effectively care for them,” says Flemming Thorup, 3Shape’s president and CEO.

Implant Studio and digital technology in general, have had a major impact on dental implantology.

In an interview with 3Shape, leading dental practitioner, Dr. Jonathan L. Ferencz summed up the considerable change by saying: “The difference digital dentistry has made to making a crown is tremendous. But the difference it has made in implant dentistry is night and day.

The dental implant market in the US is projected to reach $5 billion by 2018. With 3 million Americans already having implants. That number is predicted to grow by 500,000 per year, according to the American Academy of Implant Dentistry.

Implant Studio will be available through 3Shape resellers early Q1 2015. Availability to end-users will depend on the specific system configuration.

3Shape experts will be demonstrating Implant Studio including complete workflows using intraoral and CBCT scans, at the 2014 Greater NY Dental Meeting, November 30 to December 3, 3Shape booth 424.

For more information, please visit www.3shapedental.com/implantstudio.

 

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Repost: Randolph Hospital partners with Florida firm on new wound care center

Randolph Hospital has partnered with a Florida firm to create a new wound care center that will include two hyberbaric chambers used to help speed healing.

Jacksonville, Fla.-based Healogics, the country’s largest provider of wound care services, will provide the hyperbaric chambers as well as members of the clinical staff, including a physician. The hospital will invest about $500,000 to create space for the center.

Barbara Wolfe, vice president of strategy and service development for Randolph Hospital, said a look at the demographics of the county shows a large population with wound care problems, which now are often treated in a more costly, inpatient environment.

“When you look at the volumes in our inpatient and emergency department, there are a lot of patients who present with wounds,” Wolfe said. “With 22 percent of the county’s population uninsured, there is a higher potential for wound healing issues, and financial constraints that would make consuming care in the most expensive parts of the health system difficult.”

Would care centers use hyperbaric chambers to help increase the flow of oxygen to wounds to facilitate healing and the growth of new tissue.

The enclosed, high-pressure chambers are flooded with oxygen, which is then able to reach extremities or other areas with circulation problems to help with healing.

A population survey found about 9,500 adults within a 10-mile radius who have already come to the hospital for the treatment of diabetic ulcers or have the potential to develop such ulcers, Wolfe said.

Those types of ulcers often do not heal easily, in part because of the circulation problems that come with diabetes and obesity.

Angie Orth, chief operating officer at Randolph Hospital, said the wound care center will be in about 2,300 square feet of vacant space near the hospital main entrance.

“We’ll take that space, renovate it and make it conducive to a wound care program,” Orth said. “We will provide the capital for the upfit for the space, and (Healogics) will partner with us to bring their expertise to the table around the physician component, best practices for treatment, as well as clinical expertise around billing and coding and office staff.”

Developing the center will take about six months, Orth said.

“We’re still in the process of drawing the plans,” she said.

Resource link: http://www.bizjournals.com/triad/news/2014/11/24/randolph-hospital-partners-with-florida-firm-on.html?page=all

Check out the new COBALTT NPWT Pump Tutorial Video from Equinox Medical, LLC.

http://www.equinoxo2.com/how-to-videos/cobaltt-npwt-pump-system-video/

 

 

 

Repost: Olive Oil Accelerates Wound Healing in Burn Patients

Past studies have shown that olive oil may be effective in the treatment and healing of skin burns, when used externally. Now, a new study published in the journal Burns showed that consuming olive oil can expedite the healing process, and work from within.

Burn patients have increased nutritional needs in calories, protein as well as minerals and vitamins, so nutrition is an important factor in burn care and healing.
Antioxidant and anti inflammatory therapy have been known to be beneficial in the treatment of burns, so researchers set out to evaluate the effect of a diet rich in olive oil on the healing of burns in hospitalized patients.

The study was conducted on 100 patients who were hospitalized with second- and third-degree burn wounds on 10–20 percent of their body surface area. The patients were assigned to received either olive oil or sunflower oil in their diets.

The patients were examined daily and, while there were no significant differences in terms of in the total body surface area of the burns, there were significant differences in the duration of wound healing and hospitalization. The olive oil group appeared to have accelerated wound healing and decreased the duration of their hospitalization.

Source: http://www.oliveoiltimes.com/olive-oil-health-news/olive-oil-accelerates-wound-healing-in-burn-patients/42404

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EQUINOX MEDICAL INTRODUCES THEIR SMALLEST PORTABLE HALO MINI NEGATIVE PRESSURE WOUND THERAPY PUMP SYSTEM

EQUINOX MEDICAL INTRODUCES THEIR SMALLEST PORTABLE HALO MINI NEGATIVE PRESSURE WOUND THERAPY PUMP SYSTEM 

Smithfield, RI- October 22,2014-Equinox Medical announced at the Medtrade

convention in Atlanta, GA their newest smallest Negative Pressure Wound

Therapy(NPWT) pump system, the HALO MINI NPWT. The pump system was

designed to address the needs of clinicians and nurses for their active mobile

patients. With the recently launched HALO MINI, Equinox now offers a small

compact NPWT device for the continuum of wound care.

Equinox designed this pump with patient’s dignity in mind, to obtain agility at

home, in long term care units, or any place a patient needs to be compliant with

NPWT therapy. This enables patients to continue their needs for specific wound

requirements and maintain comfort, ease of use and cost effectiveness. Rian Mallari,

CEO, of Equinox Medical said” That’s why we designed The HALO MINI pump so; it

can be easy for a caregiver to use and improve a patient quality of life. In addition,

our black foam and white foam dressing can interface with the HALO MINI pump

system.”

Gary Schear, VP of Sales added “By providing clinicians with more choices in NWPT,

we believe we can drive better care, which improves patient outcomes and greater

value for the healthcare organizations. Wound care therapy can be discreet and

mobile. This way patients can return to their routines without compromising the

therapy needed for active wound care patients”

Halo MINI Pump System Features and Functions

• It is lightweight weighing max 2.48 pounds

• LCD Display

• Adjustable Pressure Levels

• Canister Full Monitoring

• Audio and Visual alarms

• 24 hr. battery back up

• Bluetooth Connection

• Continuous and Intermittent mode

• 300cc Integrated Disposable Canister

• Max Pump Capacity/ Air Flow Rate 5.5 liters per minute.

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For more information please visit http://www.equinoxo2.com

About EquinoxO2 Medical, LLC

Equinoxo2 Medical, LLC, headquartered in Smithfield, RI is a privately

held medical device company focused on the development of advanced

wound healing technology. Equinox is dedicated to developing and

designing innovative wound care products that are cost effective and

delivers significant clinical outcomes. Our goal and strategy is to improve

a patient’s quality of life. Our passion and dedication is to provide a better

solution in repairing and healing the human body.

For more information, please visit www.equinoxo2.com.

Media Contact

Gary Schear, Vice President of Sales

Telephone: 800-504-3150 Ext 104

Email: Gary@equinoxo2.com

FDA Invites Participation In Pilot 510(k) eSubmission Program

FDA Invites Participation In Pilot 510(k) eSubmission Program

By Chuck Seegert, Ph.D.

fda_sign

A pilot program for the electronic submission of 510(k) documents is being expanded after a successful initial test period. The online process has been likened to commercial tax software and promises to increase ease of use for companies that are submitting a 510(k) application.

A new electronic submissions (eSubmission) process may go a long way toward improving the 510(k) submission process, according to a recent announcement from the FDA in the Federal Register. While the FDA has been moving toward electronic submissions since 1999, the new approach will provide even greater harmony between the agency and parties performing submissions.

During the pilot study, all 510(k) submissions will have their initial review waived, which is a change that the FDA expects to become a permanent part of the process moving forward, according to the announcement. The new submission software is designed to ensure that each 510(k) is “administratively complete” and will not need further review. Due to the standardized submission structure, the FDA also foresees that fewer questions will need to be answered by submitting parties.

Companies may request to participate in the limited pilot program and are eligible if their submission would be reviewed by the Office of Device Evaluation’s Division of Cardiovascular Devices, Division of Neurological and Physical Medicine Devices, Division of Orthopedic Devices, or Division of Surgical Devices. This group represents an increase in the number of companies that are eligible, according to an article recently published by the Regulatory Affairs Professional Society (RAPS). Originally only a few companies in the Division of Cardiovascular Devices were allowed to participate.

Applications to participate in the program will be accepted through December 31, 2014, or as program needs allow, according to the eSubmission website. A sample of 100 submissions will be processed during this pilot study of the system.

 

 

Equinox Medical, LLC. Just launched their latest negative pressure wound therapy pump at Medtrade 2014 in Atlanta Georgia. The new NPWT pump is called Halo MINI NPWT pump system and its from the same line as the Halo XP and Halo XT NPWT pump system. The pump is small and light and only weighs in at 2.48 lbs. Eventhough it is small npwt pump, this pump is packing a serious motor. The pump has 5 liters per minute of air flow ensuring a continuous and consistent treatment.

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Prince George’s officer uses new kit to patch up dangerous chest wound in gunshot victim

Prince George’s officer uses new kit to patch up dangerous chest wound in gunshot victim

Washington Post original link: http://www.washingtonpost.com/local/crime/pg-officer-uses-new-kit-to-patch-up-dangerous-chest-wound-in-gunshot-victim/2014/10/18/e31dd212-5732-11e4-ba4b-f6333e2c0453_story.html

A gunshot wound through the chest is clearly a threat to survival, and few might expect the cop on the beat to be able to patch it up.

But a Prince George’s County officer did just that on Friday night, and, according to the county police, he kept the victim breathing and helped save a life.

The county police began training its officers this year in the use of a bag of medical equipment known as a trauma kit, and medical personnel credited Officer Brandon Farley with using his kit to prevent one of the most serious consequences of a chest wound.

The shooting occurred about 8:30 p.m. in the 5300 block of Sheriff Road, police said. After Farley ministered to the victim at the scene, the teenager was rushed to a hospital, police said, where his condition was judged to be critical but stable.

“Medical personnel at the hospital reported that Officer Farley’s quick thinking and timely medical aid stabilized the victim and prevented his lung from collapsing,” the police said.

When Farley reached the scene, which is near Eastern Avenue, he found that the victim had been shot in the back. The bullet had passed through his lung and come out through the front of his chest.

Brandon, according to the police department, immediately recognized the dangerous nature of the wound, and grabbed his trauma kit.

The victim was having trouble breathing, Farley said, the result of air entering his chest through at least one of the bullet holes. The pressure of the air prevents the lung from expanding as part of its natural operation.

Rapid treatment is required to keep the lung from collapsing entirely, impairing the victim’s ability to breathe.

Treatment calls for sealing the wound to keep air from the interior of the chest. The trauma kit contains a dressing suited to the task, Farley said. It is a sticky adhesive dressing, made of gel. Applied to the areas around the bullet holes, it seals the chest, preventing air from entering. It is called an “occlusive dressing”

Using the dressing relieved pressure on the victim’s lungs, and “seemed to allow him to breathe better and avoid a collapsed lung,” Farley said.

It appeared to be a level of care that might not be expected from a police officer sent to the scene of the shooting.

However, police said county officers have used the trauma kits to save lives several times already this year.

Police said they thought that the shooting may have followed an argument.

They said initial information indicated that the victim was shot by a black man with a medium build. Police sid he may have been wearing a a blue Helly Hansen jacket, dark pants and black boots. He fled in a dark colored four-door car, they said.

Equinox Medical, LLC. Just launched their latest negative pressure wound therapy pump at Medtrade 2014 in Atlanta Georgia. The new NPWT pump is called Halo MINI NPWT pump system and its from the same line as the Halo XP and Halo XT NPWT pump system. The pump is small and light and only weighs in at 2.48 lbs. Eventhough it is small npwt pump, this pump is packing a serious motor. The pump has 5 liters per minute of air flow ensuring a continuous and consistent treatment.

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Woohoo! Halo Mini NPWT Pump is now in the US

Equinox Medical, LLC is launching their Halo MINI NPWT Pump System at Medtrade 2014 Atlanta Georgia on October 21-23, 2014.

The negative pressure wound therapy pump designed to be one of their lightest, smallest and powerful pump in their NPWT pump product category. They are also bringing tons of sample supply of NPWT black foam dressing kits. Stop by their booth to claim one of these samples.

Halo MINI NPWT pump is designed for ambulatory patient in mind.

  • Readable LCD Display
  • Bluetooth wireless connection
  • Visual and audible alarms
  • Weighs only 2.48 lbs
  • 5.5 liters per minute
  • 300cc integrated disposable canister
  • small and compact sleek design

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What will be on their booth?

COBALTT NPWT PUMP SYSTEM

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COBALTT NPWT PUMP RECEIEVED ITS PDAC NUMBER APPROVAL

Equinox Medical’s Cobaltt Negative Pressure Wound Therapy (NPWT) Pump System and Disposable Canister PDAC Approval From Medicare

 

Smithfield, RI (PRBuzz.com) October 2, 2014 — Equinox Medical, LLC, developer of negative pressure wound therapy (NPWT) foam dressings and NPWT pump systems, announced today that it has received through the Centers for Medicare & Medicaid Services(CMS),  a new Healthcare Common Procedure Coding System(HCPCS) codes for the Cobaltt NPWT Pump System.  The Pricing, Data, Analysis, & Coding(PDAC) contractor has reviewed and approved the Coballt NPWT Pump System, HCPCS code E2402, A9900 and A7000, which is apply to the company’s Cobaltt NPWT pump system and disposable canister.

“We are excited and pleased with CMS’ decision to approve our Cobaltt NPWT Pump System & Cobaltt disposable canister.”  “We are looking forward to providing our customers, distributors and patients, an ultra-portable & affordable npwt option with the current healthcare changes and the significant reduction to the npwt fee schedule, this PDAC approval is perfect timing. Many distributors are concerned that the fee schedule reduction will hurt their npwt rental bottom line, this approval will provide a significant value to their bottom line without compromising the product quality and service”  said Joey Mallari, Chief Marketing Officer for Equinox Medical, LLC.

“Many of our distributors and patients will benefit from this HCPCS code approval. Patients can ambulate with our Cobaltt NPWT pump, improving a patient’s quality of life in both in-patient and homecare settings. In addition, the Cobaltt system can be an effective off the shelf solution that wound care clinics and physician offices can offer their patients, when discharging a patient to a home setting,” continued Mallari

The PDAC approvals will allow Durable Medical Equipment (DME) companies, distributors and other third billing parties to bill Medicare for the Cobaltt NPWT pump and disposable canisters.  Equinox Medical’s Cobaltt pump system received Food & Drug Administration (FDA) 510K clearance to market the Cobaltt NPWT pump early this year.

The Cobaltt NPWT pump weighs less than 3lbs and includes a disposable canister that connects to an npwt foam dressing kit or npwt gauze dressing kit.  The npwt dressing kit creates a tight seal around the wound allowing for negative pressure environment that draws blood to the area to potentially speed healing time. The Cobaltt NPWT pump also removes exudates from the wound bed and places them into the canister, which is then discarded as waste.

The Cobaltt NPWT pump helps manage chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, diabetic and pressure ulcers, flaps and grafts.  The system can be utilized in acute hospital settings, wound clinics, nursing homes, and inside patient’s homes under supervision of a trained healthcare professional.  The Cobaltt NPWT pump is an ultra-portable unit that is ideal for ambulatory and mobile patients.

For more product information, please visit Cobaltt NPWT Pump System

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About EquinoxO2 Medical, LLC

Equinoxo2 Medical, LLC, headquartered in Smithfield, RI is a privately held medical device company focused on the development of advanced wound healing technology. Equinox is dedicated to developing and designing innovative wound care products that are cost effective and delivers significant clinical outcomes. Our goal and strategy is to improve a patient’s quality of life. Our passion and dedication is to provide a better solution in repairing and healing the human body. For more information, please visit www.equinoxo2.com.

Media Contact

Gary Schear, Vice President of International and USA Sales

Telephone: 800-504-3150 Ext 104

Email: Gary@equinoxo2.com

Equinox Medical, LLC announces attending Medtrade to Launch their Cobaltt NPWT Pump

See Our New Product Catalog.

As a full-service and complete one source NPWT company, we partner with our clients to deliver clinically effective NPWT products and affordable financial options. Our NPWT product line is designed specifically to help all our distribution partners compete with the NPWT market leader. Utilizing decades of industry experience and functional expertise, Equinox Medical goes beyond the norm to develop new insights, drive results, and help grow your business. SEE OUR CATALOG

See Us At Medtrade, Say Hello
Booth 1669

Equinox Medical will be at Medtrade

Date:  October 21-23, 2014

Location: Georgia World Congress Center, Atlanta, GA.

 

See Our Newest Cobaltt NPWT system, Halo XT system, Foam Dressing Interface and New Bridge Kit.

Marketing and Video Support 
An Added Value To All Our Customers

Equinox Medical has created an easy way to find all our marketing brochures and all our videos on how to use all our NWPT products. .

 

Download Our Brochures and See Our Videos

Customer Line
800-504-3150

 

Website

www.equinoxo2.com negative pressure wound therapy pump and NPWT dressing kits available now

Call us if you have any clinical, product, and pricing questions.