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.

NEGATIVE PRESSURE WOUND THERAPY PUMP, NPWT PUMP, HALO MINI NPWT PUMP SYSTEM, EQUINOX MEDICAL

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.

Equinox Medical Negative Pressure Wound Therapy Product Catalog September 2014

Good news! Equinox Medical just released their current NPWT product catalog. The company allows customers to download the catalog from their website. check out the link below to download the latest Equinox Medical Negative pressure wound therapy product catalog.

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Download Equinox medical negative pressure wound therapy catalog here!

CLICK HERE TO DOWNLOAD THE NPWT PRODUCT CATALOG

KCI strikes deal with wound irrigation company

KCI strikes deal with wound irrigation company

Vac KCI

Enlarge Photo
Kinetic Concepts Inc.

Images of the V.A.C. system sold by Kinetic Concepts Inc. The InfoV.A.C. System (on left) is a wound healing therapy system designed for patients in the acute care setting.

Kinetic Concepts Inc. has struck a new distribution agreement with B. Braun Medical Inc. to be an exclusive provider of Prontosan Wound Irrigation Solution for use with V.A.C. VeraFlo Instillation Therapy in the United States.

V.A.C. VeraFlo is an integrated wound therapy that couples negative pressure wound therapy with automated instillation of topical wound treatment solutions. The Prontosan Wound Irrigation Solution will now be available in 1,000 mililiter bottles with built-in hangers and cap adaptors that provide quick and simple attachment to the V.A.C. Ulta Negative Pressure Wound Therapy System.

San Antonio-based KCI is a global medical technology company.

FDA Finalizes 510(k) Requirements For HMMD Manufacturers

FDA Finalizes 510(k) Requirements For HMMD Manufacturers

By Nick Otto

HTO FDA

Manufacturers of highly multiplexed microbiological/medical countermeasure in vitro nucleic acid-based diagnostic devices (HMMDs) should be ready to justify their performance characteristics in 510(k) or de novo submissions, according to recently finalized FDA guidance.

HMMDs help in the diagnosis of a variety of infections. The multiplex level used to define them in the new guidance is “the capability to detect ≥20 different organisms/targets, in a single reaction, using a nucleic acid-based technology and involves testing multiple targets through a common process of specimen preparation, amplification and/or detection and result interpretation.”

When submitting applications, device makers need to identify the legally marketed predicate as well as include a table showing similarities and differences between the 510(k) candidate and its comparators, the new guidance says.

Device makers are also asked to list in the intended use section of their submissions the pathogens or drug resistance markers that the test intends to detect, whether it looks at DNA, RNA, or both, as well as the “the specific population(s) for which the test is intended,” the guidance notes.

Additionally, the FDA goes on to spell out several requirements device makers should consider in their test methodology, including: test platforms, specimen collection and handling methods, how to interpret test results, and internal and external controls.

Submissions should include how the device addresses risk factors such as cross-contamination, placement and identity of assay features, false positives, and the possibility of mutations within the target organism, the guidance states.

The Regulatory Affairs Professionals Society points to the FDA’s concern that HMMDs are “not without risk,” and that the agency recommends that both positive and negative controls should be used during testing.

“In general,” the guidance notes, “external positive and negative controls should be run during the analytical and clinical studies as they are necessary to monitor the ongoing performance of the entire testing process.”

During presubmission planning, device makers are urged to consult with the agency on the use of appropriate specimens and on whether certain specimen types should be combined as equivalents. Submissions should also include whether a device’s sensitivity changes when used with frozen specimens versus fresh specimens, as well as the effects both storage temperature and repeated freeze/thaw cycles have on assay performance.

The draft guidance was issued in November 2012.  Equinox Medical Negative Pressure Wound Therapy Pump

Wound repair firm scales up

Wound repair firm scales up

ROB O’NEILL

Last updated 05:00 03/09/2014
Brian-Ward-standard

Jason Creaghan
Mesynthes founder Brian Ward

Unlimited

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It was way back in January 2008 that the then Wellington-based biomedicine company Mesynthes raised its first seed capital and set its sights on the global “soft tissue regeneration” materials market.

Now with 35 staff, US Food and Drug Administration (FDA) approval for one product and approval pending for another, plus an established distribution network into the world’s biggest biomedical market, the USA, the future is looking bright.

In layman’s terms, Mesynthes is developing and delivering safe and effective new materials to help with human tissue repair and healing.

Founder and CEO Brian Ward says the venture was launched in the belief that there was a growing need for such materials, and in the knowledge that he had found an unlikely – and, in New Zealand, also a plentiful – source for them: the fore-stomach of ruminants such as cows.

From starting in a small leased space at Industrial Research in Wellington, Mesynthes recently graduated to a new warehouse in Auckland which Ward hopes will meet the company’s needs for at least the next five years.

Current staffing levels allow Mesynthes to cover all the bases, from back-office to R&D and from manufacturing to the all-important regulatory compliance, Ward says.

“We’ve changed a lot over the last two years. We’ve broadened out across all functions.

“Mesynthes’ biggest challenge has been recruiting quality and qualified people, especially in areas such as Good Manufacturing Practices (GMP) and compliance. That was one of the primary drivers for the company’s shift to Auckland, he says.

The benefits are already being realised, with improved access to both international and local skills pools.Ward is a veterinarian by training and a member of the UK’s Royal College of Veterinary Surgeons.

But his business chops are far from shabby. He has an MBA and has worked in a range of roles with industry giants such as SmithKline Beecham.

He has also managed investment for the Foundation for Research Science and Technology, and was a founding CEO of biotechnology industry group NZBio.

He’s not prepared to talk about Mesynthes’ sales figures, but will say he is pleased with growth to date and that the company is on track to be where he wants it in five years’ time.

After launching its Endofrom Dermal Template external wound-care product last year, Mesynthes doubled down with research into a product for use inside the body.

These regenerative tissue substitutes are suitable for a range of soft tissue reinforcement and repair applications, but Ward points to abdominal reconstruction of hernias as a major opportunity.

After expected FDA clearance for that product by the end of this year a commercial launch should happen in 2015, he says.

For many Kiwi businesses, developing great products is not the issue – getting them to market is the real challenge. But Mesynthes appears to have dealt with that neatly through carefully chosen partnerships.

Endoform is distributed by Chicago-based global medical company Hollister. Ward won’t reveal who will distribute the new abdominal wall product, except to indicate a partner based on the east coast of the US is already lined up.

Mesynthes is able to develop outside of those existing partnership agreements, but there are very good reasons for focusing on the US market first. “It has high standards, is a big market and is a great place to prove technology,” Ward says.

The Kiwi company has just successfully completed a $5 million capital raising and is “well funded at the moment”, its CEO says. However, other capital raising options are always being considered.

There’s good innovation in biomedicine in New Zealand and several companies are starting to see success, he says. It’s not easy, though, with funding being a major challenge, especially pre-revenue funding.

“It’s tough getting to market in life sciences,” Ward adds.  Risks such as technology change, regulatory compliance and reimbursement uncertainty all weigh on the equation.

“The cycle time is quite long. When you get through those barriers though, the barrier to entry for competitors is quite high. Once you are in, you tend to do pretty well.”

Stereotaxis’ (STXS) Vdrive + V-Loop Receives FDA 510(k) Premarket Notification

Stereotaxis (Nasdaq: STXS) has received 510(k) clearance by the Food and Drug Administration (FDA) to market its Vdrive Robotic Navigation System with V-Loop Variable Loop Catheter Manipulator in the U.S. The Company submitted a 510(k) Premarket Notification for the Vdrive with V-Loop system in March, following completion of a 120-patient, multi-center clinical study.

The Vdrive with V-Loop system is the Company’s second Vdrive product to receive FDA clearance for use in the U.S. In July 2013, Stereotaxis was granted FDA clearance of its Vdrive with V-Sono ICE Catheter Manipulator. This past June, the Company submitted a 510(k) application to the FDA for its Vdrive with V-CAS Catheter Advancement System.

“This is another key step in our efforts to bring our full suite of Vdrive products to market in the U.S.,” said William C. Mills, Stereotaxis Chief Executive Officer. “Our work to continually evolve the Vdrive platform and expand its availability reflects our commitment to achieving greater safety, operator efficiencies and patient outcomes in the electrophysiology (EP) lab through advanced robotic technologies.”

Employed in conjunction with the Company’s Niobe® ES magnetic navigation system, the Vdrive with V-Loop system is designed to remotely control the advancement, retraction, rotation, tip deflection and loop size of a compatible circular mapping catheter, which is used in approximately 60,000 complex EP procedures worldwide each year. With the launch of this new product in the U.S., the Vdrive Duo Robotic Navigation system can eliminate manual manipulation of the two most commonly repositioned diagnostic tools utilized during ablation procedures (variable loop and ICE catheters), enabling single user workflow and greater catheter stability.