Bovie COOL-COAG™ Generator and Open Handpiece FDA Cleared

Picture: Bovie Medical

Bovie Medical announced today that it has received 510K clearance from the FDA for a new J-Plasma® generator and handpiece that incorporate Cool-Coag™ technology.

Cool-Coag™ is a new technology that combines the unique benefits of J-Plasma®, namely increased precision with minimal thermal spread, with standard monopolar coagulation and helium spray coagulation capabilities, all in one handpiece. This allows the surgeon to benefit from using a single device that offers the greater control of tissue effect that J-Plasma® delivers, while being able to switch to a monopolar or helium spray coagulation mode with just the push of a button.

“The development of Bovie’s Cool-Coag™ technology is a direct result of feedback from surgeons who have used our J-Plasma® product for procedures that require greater coagulation capability, specifically in the areas of gynecologic oncology and surgical oncology,” said Robert L. Gershon, Chief Executive Officer. “The unique flexibility of Cool-Coag™ enables the surgeon to use J-Plasma® to perform the most delicate procedures, where precision and low risk of injury to surrounding tissue are paramount and also have the full power of monopolar coagulation to control, pinpoint and diffuse bleeding as needed.”

“This new Cool-Coag™ technology has the potential to increase usage of the J-Plasma® device in many of our most complex cancer procedures. It combines J-Plasma®’s ability to be used close to vital structures with minimal collateral damage and standard full monopolar coagulation capability, all in one hand-held instrument.  Cool-Coag™ may also expand the use of J-Plasma® in additional procedures and specialties,” said Dr. Dennis Chi, head of the Ovarian Cancer Surgery at Memorial Sloan Kettering Cancer Center in New York City.

“We are pleased with our ability to continue to provide innovation that meets the needs of surgeons and are confident in the substantial growth opportunity for J-Plasma® as we continue to penetrate the market,” Mr. Gershon noted.

Scopis ENT Surgical Navigation System Cleared in USA & Canada

Photo: Scopis

Scopis, a company specializing in surgical navigation and medical augmented reality, announced today that it has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) and Health Canada Medical Device License (MDL) for its breakthrough next-generation surgical navigation products for ear, nose and throat (ENT) surgery. To support the market launch, the Company also announced that Karl Ring has joined Scopis as Vice President of Sales in North America.

“Scopis currently provides surgical navigational systems with augmented reality for ENT, craniomaxillofacial, spine and neurosurgery procedures in 50 countries worldwide,” said Bartosz Kosmecki, CEO and Founder of Scopis. “Receiving both FDA 510(K) and MDL clearance enables the immediate commercial launch of our innovative ENT-based products in these significant North American markets.”

Mr. Kosmecki added, “We are excited to welcome Karl, a highly-experienced sales executive in our sector, to lead our commercialization efforts in North America. Operating from our new location in Cambridge, Massachusetts, we are well-prepared to enter these markets.”

Scopis designs surgical navigation systems that use augmented reality (AR) technology, where real-world imaging data from the surgical environment is enhanced by integrating computer-generated images. Scopis’ next-generation Target-Guided Surgery Systems (TGS)*, lead a surgeon along mapped-out pathways directly to anatomical targets using AR-generated images overlaid onto the surgeon’s endoscopic view.

The heart of the Scopis technology is the premium Hybrid Navigation platform that is based on a small and portable unit that supports optical, electromagnetic, and simultaneous hybrid tracking*. It allows surgeons to choose the best-suited technology for variety of surgical procedures across different disciplines. The modularity and versatility of this powerful platform also permits interdisciplinary use.

“With my experience in the US market, specifically in the ENT space, I’m confident that this breakthrough technology in surgical navigation will have a substantial impact on the ENT community and patients. I am looking forward to bringing these products to surgeons performing sinus procedures in both hospital and office-based settings,” said Karl Ring, VP Sales North America of Scopis.

Karl Ring joins Scopis as a seasoned expert in the fields of sales, marketing and business development for medical devices, including those specifically for ears, nose and throat. Most recently, Karl held the position of Director of Market Development, ENT at Smith & Nephew, Inc., where he also provided strategic consulting for transactions dealing with business and sales development. Prior to that, he held similar roles, ranging from Business Development, International, at ENTrigue Surgical to Vice President of Sales and Marketing at Biotronic NeuroNetwork and Regional Sales positions with Medtronic ENT.

Soruce: Scopis GmbH

Stryker chooses Microsoft HoloLens to design OR

Stryker has set out to improve the process for designing operating rooms for hospitals and surgery centers.

You may not be aware of it, but surgical disciplines from general, to urologic, orthopedic, cardiac, and ear nose and throat (ENT) use shared operating rooms. These specialties have widely different needs when it comes to operating room configuration and setup. Everything from lighting, to equipment, tools, and even patient orientation, varies depending on who is using the operating room at any given moment. Equipment placement is critical as it effects ergonomics, efficiency, and task load, all of which have the potential to burden staff and slow procedures.

Today, for hospitals to successfully design operating rooms that will accommodate these various medical disciplines, a critical meeting must take place. In this meeting, the heads of each surgical discipline, along with their staff, are physically present to outline the desired layout and implementation needed to successfully complete their procedures. This is a complicated and time-consuming process where people and a complex array of technology and equipment are shuffled around to determine what goes where, and when, to see how it will all fit.

Recognizing that the current model of operating room design needs to be evolved from 2D to 3D, and knowing that the needs of these specialties can be quite divergent, Stryker has found a way to design a shared operating room that can accommodate all surgical disciplines in a far more efficient manner.

Instead of needing all of the people from each surgical discipline, all the physical equipment required across all medical disciplines, all in one room at the same time, Stryker is now able to modify and build different operating room scenarios with holograms. No more time-consuming sessions where everyone needs to be physically present and no more need to move around heavy and expensive equipment to get a sense for how everything all fits together.

By / General Manager, Microsoft HoloLens and Windows Experiences

Source: Microsoft

JK Medirise sees opportunities in Latin America and Africa

Brückenkopf GmbH recently interviewed with Mr. Ketan Munjani, Marketing and Sales Manager at JK Medirise.

(Q: Question from Brückenkopf GmbH / A: Answer from Mr. Ketan Munjani by JK Medirise)

Q: Mr. Munjani, what is your current portfolio? We understand that your company is a reputable medical device manufacturer, which categories do you focus on?

A: Our company was incorporated in the year 2012, we manufacture Single Use Medical Devices for transfusion & infusion, urology and cardiology purposes. We also deliver anesthesia, surgery, gastro-enterology, and surgery dressing products, and our product lines are expanding.

Q: What are the major markets of your company? The domestic one or international market?

A: We identify the precise need of the client related to the product and delivers products following international quality standards. We serve the international market in the worldwide healthcare sector, and we have obtained and maintained very strong international reputation.

Q: Do you have R&D capabilities of your company, or do you co-operate with third parties?

A: Our company has highly qualified and skilled team members who work in professional environment in the work place. R&D is important to the company. We have our own R&D capabilities but at same time we also work with third parties in terms of R&D to offer the most accurate and reliable products to our customers.

Q: How do you manage product quality control of your products? Do you hold any quality certifications to your products?

A: Yes. We have ISO 13485 Certificate & CE Certificate. In our company quality holds the top priority. Every item passes through strict quality checks at various stages before they are finally approved for delivery.

Q: What do you see as challenges and opportunities in the market in 2017?

A: We foresee new innovative Product as challenges, and we think there are vast opportunities in Latin American and African countries for our range of product. As an international oriented company, we evaluate our success by keeping the aspects of our customers, physicians or healthcare professionals together, as they are the ones whom we are working for.

Background info of JK Medirise:

AtriCure Announces Approval of cryoICE Platform in Japan

AtriCure, Inc. announced that it has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for its cryoICE™ platform and CRYO2 cryoablation probe. The approval marks the first time that these products will be available in the Japanese market.

“We are pleased to have this approval in hand, and to be able to bring our cryoablation products to the Japanese market,” said Mike Carrel, President and CEO of AtriCure. “This new approval will augment our offerings in the Japanese market and offer a leading solution to cardiac surgeons and the Japanese patients for the treatment of Afib.”

The company’s distributor in Japan, Century Medical Inc. (CMI), worked closely with AtriCure to secure approval. Product will be immediately available for sale as soon as the reimbursement application is completed, which is expected in the fourth quarter.

“Japanese surgeons have been waiting a long time for this moment. We believe many patients will benefit from this technology and look forward to bringing it to market,” said Takahiko Motani, president and CEO of CMI.

Source: AtriCure

Intuitive Surgical established joint venture in China

Intuitive Surgical and Shanghai Fosun Pharmaceutical (Group) Co., Ltd. announced a joint venture to research, develop, manufacture and sell innovative, robotic-assisted catheter-based medical devices.

The joint venture between Intuitive Surgical, the global leader in robotic-assisted minimally invasive surgery, and Fosun Pharma, a leading healthcare group strategically comprising the complete value chain, will initially produce products targeting early diagnosis and cost-effective treatment of lung cancer, one of the most commonly diagnosed forms of cancer in the world.

The technology will be used in robotic-assisted medical devices based on catheters, and incorporates proprietary intellectual property developed or owned by Intuitive Surgical.  The joint venture will be registered in Shanghai, where it will perform research and development activities and manufacture catheter-based products for global distribution. Distribution in China will be conducted by the joint venture. Distribution outside of China will be conducted by Intuitive Surgical.

Source: Intuitive Surgical