Regulatory – Page 31

May 04, 2017

LONDON–(BUSINESS WIRE)–Regulations for medical and diagnostic devices are changing in tune with advances in technology, new and innovative medical treatments, and the need for more effective diagnostic practices. Infiniti Research expects the market for medical devices to experience positive growth in the coming years as new rules and regulations eliminate counterfeit and dangerous products, increasing consumers’ trust and allowing established and reputable vendors to flourish.

Market Insights

New European Union regulations on medical devices will help to modernize public health and increase patient safety and outcomes. First proposed in 2012, the new rules (titled “the EU Medical Devices Regulation and In-Vitro Medical Devices Regulation”) came into effect in early April of this year following trilogue negotiations between the European Parliament, European Council, and European Commission. They will fully apply after a transitional period of three years for medical devices and five years for in-vitro diagnostic devices.

These regulations are replacing and modernizing three directives pertaining to in-vitro diagnostic products and medical devices with an aim to ensure both patient safety and product innovation. Both of the new regulations will improve the quality and safety of medical devices, increase market safety and monitoring, and will make important information about vendors and medical device products more easily available for patients to access. They now allow for random inspections of producers’ facilities after devices have been placed on the market, require clinical evidence of medical device safety to be provided by manufacturers, introduce an “implant card” for patients that will enable healthcare practitioners to track and monitor which product has been implanted, and have been expanded to cover aesthetic products—such as coloured contacts—that have the potential to harm consumers.

How Can Infiniti Research Help?

As technological standards and regulations for the healthcare industry and medical devices continue to change, it can be difficult for vendors to anticipate demand and prepare for new challenges. Market intelligence can be extremely beneficial in allowing vendors to understand how new laws will affect their business, strategize to overcome major obstacles and challenges, and to identify key competitors. It also enables them to adhere to region-specific regulations in each country they do business in, ensuring the safety of their customers.

Infiniti Research was recently approached by a global manufacturer and supplier of medical devices to assess the market landscape for radiography systems in the US. The insights provided by Infiniti’s analysts helped the client to gain a comprehensive understanding of the distribution structure for floor mounted radiography systems, as well as the growth strategies followed by market leaders.

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About Infiniti Research

Established in 2003, Infiniti Research is a leading market intelligence company providing smart solutions to address your business challenges. Infiniti Research studies markets in more than 100 countries to help analyze competitive activity, see beyond market disruptions, and develop intelligent business strategies. With 13 years of experience and offices across three continents, Infiniti Research has been instrumental in providing a complete range of competitive intelligence, strategy, and research services for over 550 companies across the globe.

Contacts

Infiniti Research
Jesse Maida
Media & Marketing Executive
US: +1 630 333 9501
UK: +44 208 123 1770
www.infinitiresearch.com
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Robert Lowes – April 27, 2017

A southern California practice management company called Monarch Medical Group used to advertise that it could provide physicians with new revenue streams from transdermal pain creams, oral medication dispensing, and urine drug-screening tests.

Those revenue streams could lead to prison for 21 physicians charged in a California state court last week with fraudulently billing workers’ compensation insurers for these ancillary services and accepting kickbacks for patient referrals. It was all part of a scheme allegedly masterminded by Tanya King and her husband, Christopher King, owners of Monarch Medical Group and related companies, according to state prosecutors and the California Department of Insurance (CDI).

The Kings also were charged in the case, as were two pharmacists who owned a pharmacy and a physician assistant.

“The Kings and their co-conspirators played with patients’ lives, buying and selling them for profit without regard to patient safety,” said CDI Commissioner Dave Jones in a news release.

From 2011 to 2015, the operation fraudulently billed insurers for $40 million and collected more than $23 million for services rendered to some 13,000 patients. The 21 physicians netted almost $2.2 million in kickbacks, which were labelled as marketing expenses to make them look legitimate, prosecutors said. The average age of the physicians was 57.

Buy for $40, Bill for $700

The scams alleged by prosecutors were based on the three ancillary services that Monarch Medical Group advertised on its website.

READ THE REST HERE

Salt Lake City, UT, April 28th, 2017 – Innovasis, Inc. is the first company to receive US FDA 510(k) clearance for a Stand-Alone ALIF* System made from PEEK-OPTIMA™© HA Enhanced polymer from Invibio©. Designed for use in spinal-fusion procedures, the implantable Ax™ Stand-Alone ALIF System implants contain osteoconductive hydroxyapatite (HA) fully integrated into the matrix of the polymer and exposed on all surfaces of the body of the implant, including within the inner walls of the graft chamber.

This is the second PEEK-OPTIMA HA Enhanced device marketed by the company. At the end of Q416 the company launched a PxHA a PLIF device made from the same material.

The Innovasis Ax Stand-Alone ALIF System is an intervertebral fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). The implant is used to facilitate fusion in the lumbar spine and is inserted using an anterior lumbar interbody fusion (ALIF) procedure.

The Ax Stand-Alone ALIF implant also features a tapered leading edge, which aids in implant insertion within limited anatomical space. It also features a slightly convex profile to match the anatomy of the spine and provide a stable anti-migration surface during the fusion process. The large graft cavity provides increased volume for autograft loading.

About Innovasis
Innovasis, Inc. is a rapidly growing company engaged in the research, development, manufacturing, and marketing of spinal implant devices and related products. Innovasis offers a spinal product line with implants and instruments that address the major pathologies and focus areas of traditional spinal surgery. Innovasis is fully committed to providing surgeons and distributors with training, support and excellent customer service, thus ensuring the establishment of a strong and long-term strategic partnership.

AUBONNE, Switzerland, April 26, 2017 (GLOBE NEWSWIRE) — Intuitive Surgical, a global technology leader in robotic-assisted, minimally invasive surgery, announced today that its new da Vinci X Surgical System received CE Mark approval in Europe. The da Vinci X System will provide surgeons and hospitals with access to some of the most advanced robotic-assisted surgery technology at a lower cost.

The launch of the da Vinci X System underscores Intuitive’s commitment to meeting customers’ needs with a strong value-oriented portfolio of cost-appropriate technologies and an array of financing options.

“Over the past 21 years, Intuitive Surgical pioneered robotic-assisted surgery and we continue to lead the way in developing and bringing to market innovative technologies, outcomes-focused products and value-oriented solutions,” said Dr. Gary Guthart, CEO of Intuitive Surgical. “Our surgeon, hospital and healthcare customers around the world told us that robotic-assisted surgery matters for their programs and their patients while underscoring the importance of providing choice from a clinical, technological and cost standpoint. The da Vinci X product offering provides a lower-cost solution to meet the needs of customers who want a choice in price points, while offering access to many of our recent innovations.”

The da Vinci X System offers surgeons and hospitals access to Intuitive’s portfolio of advanced, innovative robotic-assisted surgical technologies – and its full ecosystem of programs, support, services, and solutions –at a lower price. The System uses the same vision cart and surgeon consoles that are found on our flagship product, the da Vinci Xi^® System, enabling our customers the option of adding advanced capabilities, and providing a pathway for upgrading should they choose to do so as their practice and needs grow.

The da Vinci X System enables optimized, focused-quadrant surgery including for procedures like prostatectomy, partial nephrectomy, hernia repair, benign hysterectomy and sacrocolpopexy, among others. The System features flexible port placement and state-of-the-art 3D digital optics, while incorporating the same advanced instruments and accessories as Intuitive’s flagship system. The new system drives operational efficiencies through set-up technology that uses voice and laser guidance, drape design that simplifies surgery prep, and a lightweight, fully integrated endoscope.

“The da Vinci X System is a value-oriented, highly capable offering that meets – and responds to – our customers’ economic and clinical needs,” said Damien Desmedt, General Manager of Intuitive Surgical in the United Kingdom, Ireland, and Nordic countries. “In the countries we serve around the globe, we know that customers have different needs and wants, and we strive to provide an array of choices to meet their needs today and in the future. The da Vinci X System helps us to continue to do this.”

About Intuitive Surgical, Inc.

Intuitive Surgical, Inc. (Nasdaq:ISRG), headquartered in Sunnyvale, Calif., is a global technology leader in robotic-assisted, minimally invasive surgery. Intuitive Surgical develops, manufactures and markets the da Vinci Surgical System.

About the da Vinci Surgical System

There are several models of the da Vinci Surgical System. The da Vinci Surgical Systems are designed to help surgeons perform minimally invasive surgery. da Vinci Systems are not programmed to perform surgery on their own. Instead, the procedure is performed entirely by a surgeon who controls the system. da Vinci Systems offer surgeons high-definition 3D vision, a magnified view, and robotic and computer assistance. They use specialized instrumentation, including a miniaturized surgical camera and wristed instruments (i.e., scissors, scalpels and forceps) that are designed to help with precise dissection and reconstruction deep inside the body.

Intended Use

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Model IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures, thoracoscopically-assisted cardiotomy procedures, and trans-oral otolaryngology surgical procedures restricted to benign tumors and malignant tumors classified as T1 and T2, and for benign base of tongue resection procedures. The System can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The System is indicated for adult and pediatric use (except for trans-oral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment.

The da Vinci X Surgical System is a class 2b CE 0543 marked medical device under the European Medical Devices Directive (93/42/EEC) manufactured by Intuitive Surgical, Inc. Refer to the Instructions For Use before use.

Forward Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding regulatory clearances to market the da Vinci X System in the US. These forward-looking statements are necessarily estimates reflecting the best judgment of our management and involve a number of risks and uncertainties that could cause actual results to differ materially from those suggested by the forward-looking statements. These forward-looking statements should, therefore, be considered in light of various important factors, including those under the heading “Risk Factors” in our annual report on Form 10-K for the year ended December 31, 2016, as updated from time to time by our quarterly reports on Form 10-Q and our other filings with the Securities and Exchange Commission. Statements using words such as “estimates,” “projects,” “believes,” “anticipates,” “plans,” “expects,” “intends,” “may,” “will,” “could,” “should,” “would,” “targeted” and similar words and expressions are intended to identify forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. We undertake no obligation to publicly update or release any revisions to these forward-looking statements, except as required by law.

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/0c20bf18-fcc5-4d29-8bab-4ada1ab29eae

PN1035581rA EU 4/2017

Contact
JPA Health Communications
kperry@jpa.com
+44203 884 0650

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WALNUT CREEK, Calif., April 27, 2017 /PRNewswire/ — Providence Medical Technology, Inc., an innovator in tissue-sparing cervical spine technology, today announced the U.S. Patent Office’s issuance of four additional patents, Nos. 9,622,873; 9,622,791; 9,622,874; and 9,629,665, covering various aspects of its proprietary DTRAX® and CAVUX® posterior cervical spinal fixation technologies.

These patents cover, among other things, posterior placement of an implant in a facet joint using a chisel and guide tube; placement of an implant in a facet joint using a forked guide tube; placement of implants of various configurations in a cervical facet joint; and distraction of a facet joint after posterior placement of an implant in the facet joint.

These four recent issuances bring the number of issued patents in Providence’s growing patent portfolio to 35 total. Providence has already filed approximately 40 other applications in various stages of prosecution in the U.S. and overseas covering various aspects of its proprietary technologies.

“We have invested tremendous resources over the years in filing both broad and detailed disclosures covering the important aspects of our technology for tissue-sparing posterior cervical and spinal intervention,” commented Jeff Smith, Chief Executive Officer. “We are extremely pleased with the continued and accelerating growth of our patent portfolio as it provides the means to protect our innovations and rapidly expanding business.”

About Providence Medical Technology, Inc.
Providence Medical Technology, Inc. is a privately-held medical device company focused on innovative solutions for cervical spinal conditions. The company has pioneered a proprietary, tissue-sparing approach to posterior cervical fusion. Providence has developed surgical instrumentation and implants that offer unique benefits in the $2 billion worldwide cervical spine market. The Providence family of products includes the DTRAX® Spinal Instrumentation System, CAVUX® intervertebral implants, and the ALLY™ line of bone and facet screws. All products are shipped-sterile and single-use to maximize efficiency and ensure consistent quality and performance. For more information, visit www.providencemt.com.

SOURCE Providence Medical Technology, Inc.

Contacts

Press Contact USA:
joimax^® Inc.
Melissa Brumley
001 949 859 3472
Melissa.brumley@joimaxusa.com

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By Christine Ayala, The Hill Extra – 04/18/17

Regulators are mulling tightened oversight over physician-owned distributors of medical products, on fears that conflicts of interest could lead to fraud.

Some hospitals have set up barriers to avoid anti-kickback entanglements with device distributors, and the Medicare Payment Advisory Commission (MedPAC) is looking at more specific requirements in congressional recommendations. Some commissioners argue these types of physician-owned distributors of medical products should be outlawed.

At issue are distributors making money by selling devices ordered by their doctor owners for surgical use on their own patients. Physician-owned distributors, or PODs, operate as middlemen, buying a device from manufacturers and selling the device to a hospital at a higher price, although ownership of a distributorship is not always obvious.

The practice developed as a way for physicians to cluster buying power and potentially save on device costs.

Devices from these distributors are bought at the same price or higher than those available from manufacturers, a practice which lead some to call these entities “inherently suspect,” according to a recent Office of Inspector General report.

The medical device industry also sees a need for caution.

READ THE REST HERE

SALT LAKE CITY, UT–(Marketwired – Apr 24, 2017) – Amedica Corporation (NASDAQ: AMDA), an innovative medical device company that develops and commercializes silicon nitride, is pleased to announce it has been granted marketing clearance for its Valeo interbody fusion devices in Australia.

The Valeo product line is made entirely of Amedica’s proprietary medical grade silicon nitride ceramic — an ideal material for fusion because of its nanostructured surface, osteoconductivity, osteoinductivity, anti-microbial properties, and ease of radiographic imaging.

“The Australian clearance is a tremendous opportunity for Amedica. Interestingly, during 1986-1988, Australian surgeons and engineers were the first to synthesize reaction-bonded silicon nitride, and implant the material in lumbar spine fusion patients. Favorable outcomes in terms of pain relief and successful fusion were reported at the 15-year follow-up time interval. Thus, the pioneering clinical use of silicon nitride in spine fusion originated in Australia, and we are excited to see the material return to its place of birth,” said Dr. Sonny Bal, CEO. “The successful outcomes from Australia are now validated by 45 scientific papers published by Amedica in top-tier peer journals, and clinical data that will be published throughout this year. We look forward to working with Australian surgeons, and providing them with improved options for spinal fusion surgery.”

About Amedica Corporation
Amedica is the only manufacturer of medical grade silicon nitride — an innovative biomaterial technology ideal for use in spinal fusion and across a variety of medical applications. The Company’s products are manufactured in its ISO 13485 certified manufacturing facility located in Salt Lake City, Utah. Amedica’s FDA-cleared and CE-marked spine products are currently marketed in the U.S. and select markets in Europe and South America through its distributor network.

For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.

Forward-Looking Statements
This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release include, but are not limited to, the Company’s opportunities for global expansion, and the Company’s future commercialization plans. Such statements are subject to risks and uncertainties such as whether the FDA approves the Company’s submission, the timing of such approval and the Company’s success in commercializing its products. Additional factors that could cause actual results to differ materially from those contemplated within this press release can also be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 23, 2016, and in Amedica’s other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements.

CONTACT INFORMATION

Contacts:
Amedica IR
801-839-3502
IR@amedica.com

April 21, 2017

FORT LAUDERDALE, Fla.–(BUSINESS WIRE)–Stimwave LLC, a medical device manufacturer and independent research institute headquartered in South Florida, today announced it has been awarded a Distribution and Pricing Agreement (DAPA) by the Defense Logistics Agency. Stimwave, which distributes the Stimwave Freedom Spinal Cord Stimulation (SCS) System and StimQ Peripheral Nerve Stimulator (PNS) System, received a five-year contract, negotiated by TAMM Net, Inc., which is the first global agreement for spinal cord stimulators by a U.S. government agency.

“We are extremely pleased Stimwave received a DAPA. The successful product validation process now allows Stimwave products to be accessed and used by doctors at all military treatment facilities across the globe,” said Laura Perryman, CEO and president of Stimwave. “Multiple facilities have been pleased to hear they can now acquire our products through their purchasing vehicles.”

Stimwave’s devices use Wireless Pain Relief^®technology and are 95 percent smaller than any other neuromodulation device on the market. Stimwave’s wireless device delivers small pulses of energy to specific nerves, triggering a reaction that enables the brain to remap pain pathways, thus providing pain relief. The device is fixed in place by an anchor, so it stays “in line” with the body’s nerves, allowing a freedom of motion that is impossible with bulkier implanted devices.

Stimwave launched its FDA-cleared devices for the relief of chronic back and leg pain to a limited number of patients throughout 2015. In March 2016, Stimwave was granted FDA 510(k) for the relief of peripheral nervous system (PNS) pain, becoming the only neuromodulation device manufacturer cleared by the FDA to help reduce chronic neuropathic pain at most locations throughout the body, from back and leg pain addressed by spinal cord stimulation to PNS treatment for shoulder pain, wrist and elbow pain, knee pain, hip pain and more.

About Stimwave

Stimwave Technologies Incorporated is a privately held medical device company engaged in the development, manufacturing, and commercialization of wirelessly powered, microtechnology neurostimulators, providing patients with a convenient, safe, minimally invasive, and highly cost-effective pain management solution that is easily incorporated into their daily lives. Stimwave’s goal is to evolve its patented, cutting-edge platform into the default for neuromodulation, increasing the accessibility for patients worldwide while lowering the economic impact of pain management. www.stimwave.com

About TAMM Net, Inc.

TAMM is a consultancy that provides services to biomedical manufacturers seeking opportunities or overcoming obstacles presented by the U.S. government. TAMM provides complete reimbursement, full federal contracting services, regulatory affairs, and facilitating sales to federal medical facilities. http://www.tammnet.com

Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the Company’s products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements.

Contacts

Glodow Nead Communications
Evan Nicholson, Sonia Sparks, Kati Stadum, and Sarah Rogers, 415-394-6500
StimwavePR@GlodowNead.com

By PR Rocket on April 20, 2017

Ziptek LLC, founded by Sarasota-based orthopedic surgeon Dr. William Bennett M.D., is proud to announce its newly obtained FDA-approval for the ZipE® knotless tissue repair and attachment device. ZipE® is an absorbable button that moves down a suture, locking itself from moving backward with each forward movement. It can be used in minimally-invasive techniques and open surgeries to accomplish tissue-to-tissue and tissue-to-bone repair. Most importantly, since it functions similar to a zip tie, ZipE® prevents the need to tie knots in small spaces and creates a superior contact of the repaired tissue compared to any other device on the market.

Ziptek LLC exhibited at the March 2017 AAOS Meeting in San Diego and garnered significant national and international interest by surgeons and distributors alike for the newly FDA-approved ZipE®. Given that the U.S soft tissue repair market generates $2 to $3 billion per year, with at least 500,000 rotator cuff and 1,000,000 ankle ligament cases annually, the ZipE® can play a major role in transforming the surgical outcomes of countless patients. It offers the unprecedented ability to disperse pressure across a larger surface area and help prevent the suture from tearing out through the tissue. This makes ZipE® incredibly valuable for better and improved tissue healing with a far lower rate of non-healing and re-tears.

READ THE REST HERE

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Current Issues in Spine

Stricter Medical Device Regulations Will Improve Patient Outcomes, Says Infiniti Research

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Twenty-one Physicians Charged in Kickback Scheme

Buy for $40, Bill for $700

Innovasis receives 510k for first Stand-Alone ALIF System made from PEEK-OPTIMA™© HA Enhanced polymer

Intuitive Surgical Receives CE Mark for Latest da Vinci® Robotic-Assisted Surgical System

Providence Medical Technology Announces Issuance of Four Additional U.S. Patents

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Contacts

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CONTACT INFORMATION

Stimwave Awarded U.S. Government DAPA Contract

Contacts

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