KFAR SABA, Israel, 9-Nov-2021 — /EPR HEALTHCARE NEWS/ — Origami, a leading provider of no-code business process automation software for Medical Device and other industries, and citoQualis, a regulatory and business advisory leader for EU Medical Device companies, are announcing a partnership to help Medical Device startups get products to global markets faster.
Medical Device startups face unique pressures due to numerous country-specific regulations. This new partnership will help companies efficiently manage their regulatory approval processes, and enable rapid business growth.
Origami’s medical device customers operate around the world. With recent EU regulatory updates, companies are seeking strategic regulatory and business guidance to help them get and maintain product approval in that geography. The new partnership will provide Origami customers with access to citoQualis expertise in business and complex regulatory landscapes.
The citoQualis team points out that Medical Device startups have global workforces that “expect to access their systems from wherever they’re located, and to use those systems to collaborate internally and with citoQualis†says Mr. Wolfgang Werner, CEO of citoQualis.
According to Mr. Werner, “As advisors, it’s our job to identify opportunities and share our insights. For startups, the faster a product moves from idea to production, the better. With Origami’s flexibility, we are able to give our clients a software option that works for them now and as they scale.â€
Germany and other EU countries have strong medical device startup ecosystems, which citoQualis is well connected to. Origami is excited to work with citoQualis and the startups they advise, noting how both companies focus their solutions and teams on helping customers succeed in complex environments.
Yaniv Shimony, CEO of Origami says “startup CEOs recognize Origami’s business value, in that they always have the solution their company needs. When you create a new and innovative medical device, using inflexible software point solutions slows your business down. With Origami, information is instantly available about any part of your business such as sales, quality, design, product approvals, manufacturing, equipment maintenance, purchasing, supplier compliance, invoicing, complaints and more.â€
Existing customers will be able to maintain and expand EU market access by working with local regulatory experts, facilitating hundreds of millions of Euros of revenue.
LJUBLJANA, Slovenia, 21-Sep-2018 — /EPR HEALTHCARE NEWS/ — The latest study published in the World Journal of Urology (Comparison between erbium‑doped yttrium aluminum garnet laser therapy and sling procedures in the treatment of stress and mixed urinary incontinence – https://doi.org/10.1007/s00345-018-2445-x) provides further confirmation that Fotona SMOOTH® laser technology is a safe, effective and minimally-invasive solution for stress and mixed urinary incontinence (SUI and MUI). The article, written by Dr. Nobuo Okui, compares Fotona’s minimally invasive IncontiLase® Er:YAG laser therapy with the more conventional TVT and TOT surgical sling procedures.
Asian Study Confirms Favorable Results of Fotona SMOOTH® Laser Therapy for Urinary Incontinence
In the study performed by Dr. Okui, 50 Japanese women were treated either surgically (tension-free vaginal tape – TVT or transobturator tape – TOT) or with a Fotona laser. The 1-h pad test, ICIQ-SF, and overactive bladder-symptom score were used to assess the patients before and 12 months after treatment. Laser therapy was performed by first applying a local anesthetic to the vaginal wall and then inserting a probe into the vagina. Laser irradiation was performed for 20 min with an Er:YAG wavelength of 2940 nm (Dynamis XS, Fotona) for a total of three treatments (alternating every month). Results of the 1-h pad test and ICIQ-SF showed comparable improvements in SUI in the sling and laser therapy groups, while some of the patients with MUI in the TVT and TOT groups showed exacerbation. In conclusion, the TVT and TOT procedures and the laser therapy are comparable for SUI; however, laser therapy is superior in terms of MUI and complications. The study thus once again confirms the safety and efficacy of Fotona SMOOTH® laser therapy for urinary incontinence.
Urinary Incontinence Treatment Options
Conventional treatment options for urinary incontinence are surgical, and include TVT or TOT sling procedures, which involve inserting a synthetic material. Problems often arise with artificial meshes that require new treatment methods. With the Fotona SMOOTH® Er:YAG laser thermotherapy (also known as IncontiLase®), the goal is to provide a minimally invasive therapy based on vaginal collagen hyperthermia followed by collagen remodeling and new collagen synthesis, which results in overall regeneration of aged or stressed vaginal tissues and subsequently greater support to the bladder.
Unique Fotona SMOOTH® Technology for Maximum Safety
Patient safety is the primary concern and, for this reason, the patented Fotona SMOOTH® technology holds a very unique position within the spectrum of gynecological treatment options. It is a non-surgical procedure (no incisions) and without implants or appliances. The Fotona SMOOTH® method of dual-tissue regeneration is completely non-ablative and therefore minimally invasive to the vaginal wall. The treatment involves an additional superficial heat-shocking mechanism of tissue regeneration, and a unique self-regulating safety feature. These dual-tissue regeneration characteristics of the Fotona SMOOTH® Er:YAG laser allow for an exceptionally high degree of safety and efficacy in thermotherapy of the vaginal wall. This is what makes Fotona SMOOTH® a significantly safer alternative to many widely used and more-invasive procedures.
Evidence-Based Laser Medicine
Over the past few years numerous (over 35) other studies on Fotona SMOOTH® laser therapy have been published by distinguished gynecologists from around the globe in some of the most trusted and renowned international scientific journals, all with favorable results (https://www.laserandhealthacademy.com/en/practitioners/recommended-reading/gynecology/). One such noteworthy clinical paper published in March 2018 by Dr. Adolf Lukanovic and Dr. Mija Blaganje is the first randomized controlled trial study (on 114 premenopausal parous women) to evaluate the efficacy and safety of non-ablative Er:YAG laser therapy as an alternative non-invasive treatment of SUI and the improvement of sexual gratification (published in the European Journal of Obstetrics & Gynecology and Reproductive Biology. 2018 (224): 153-158). The results from this study indicate that a single session of IncontiLase® treatment improves the impact of SUI symptoms on quality of life and sexual function in premenopausal parous women significantly better than placebo.
In another Asian study, Dr. Yi-Wen Tien et al. from the Chang-Hua Hospital in Taiwan examined the effects of laser treatment for female SUI on pad weight, urodynamics, and sexual function in 35 women (published in the International Urogynecology Journal. 2017; 28(3): 469-476). The study reveals that the effect of IncontiLase® treatment for mild SUI was moderate at the 6-month follow-up. Moreover, it improved LUTS, quality of life, and the sexual function of both partners. The authors conclude that the IntimaLase® procedure is very effective in the treatment of SUI and is not associated with any severe adverse effects.
Similarly, Dr. Yi-Hao Lin et al. from the Chang Gung Memorial Hospital in Taiwan obtained favorable results. Their study investigated the effects of non-ablative laser treatment on overactive bladder (OAB) syndromes, SUI and sexual function in 30 women with urodynamic stress incontinence (published in the Taiwanese Journal of Obstetrics & Gynecology. 2017 (56): 815-820). The results showed that IncontiLase® treatment can resolve SUI and coexistent OAB symptoms three months after therapy, while repeated laser therapy may be necessary after six months. The results also revealed that sexual gratification improved, while no major adverse effects were noticed.
The quantity and quality of the studies performed with Fotona SMOOTH® laser therapy is such that Fotona’s Dynamis has been cleared in the European Union for SUI (IncontiLase®), vaginal laxity – vaginal relaxation syndrome (IntimaLase®), genitourinary syndrome of menopause – GSM (RenovaLase®) and pelvic organ prolapse (ProlapLase®), giving women the option to choose a safer and less-invasive treatment alternative. In Asia, the Taiwan Food and Drug Administration has already cleared Fotona Dynamis for mild to moderate SUI, and the Singapore Health Sciences Authority has cleared the Dynamis for the treatment of SUI and GSM.
The province is teaming up with partners to provide health-care professionals with better and faster access to medical information.
Health Minister Michael Murphy announced on Monday that new specialty software had recently been integrated with IT systems in New Brunswick’s regional hospitals and other health-care facilities.
“Providing all provincial health-care workers with a single secure access portal to provincial health information systems represents a significant modernization of our health system,†said Murphy. “This is a significant milestone in our One Patient One Record project, and further ensures the consistent delivery of care, regardless of the patient’s location.â€
The access portal is supported by AnyWare Group’s ROAM platform. In addition to improving working conditions for health-care professionals, it will better protect patient privacy by providing to New Brunswick’s health-care professionals secure remote access to all of the province’s health information systems.
Health officials said that this innovative project will have an impact on the overall efficiency and cost-effectiveness of the system.
“Sharing a single common secure infrastructure across the province’s entire health-care system provides cost savings for the province, and a consistent experience for health-care workers,†said Gordon Gilman, CEO of FacilicorpNB. “This project is a result of excellent teamwork and collaboration between the regional health authorities, the Department of Health and FacilicorpNB.â€
The portal will increase the efficiency of the health-care system by allowing clinicians to devote more time to patients, and improve patient safety. Health officials also mentioned the portal’s impact on innovation and cost-effectiveness, thereby lowering health-care expenditures and reducing wait times.
“AnyWare Group is pleased to be supporting New Brunswick’s iHER (interoperable electronic health record) initiative,†said Robert Lalonde, AnyWare Group Inc. CEO. “Providing a single secure remote access point for all health-care workers across the province makes New Brunswick a North American leader in e-health.â€
The launch of the ROAM platform follows the introduction of government legislation designed to protect personal health information and privacy.
About AnyWare Group
AnyWare Group is the leading remote access solution provider for hospitals and healthcare organizations. AnyWare Group’s award-winning ROAM Platform enables clientless remote access to all applications from any device (PCs and Macs) without requiring the management of users’ computers. Through the ROAM portal, organizations present all relevant applications to authorized users, when and where required. More information is available at www.AnyWareGroup.com.
World Association of Laparoscopic Surgeons is organizing International Conference on Recent Advances of Minimal Access Surgery every year. In 2009 it is going to be held in Istanbul Turkey under the presidency of Dr. Gokhan Goynumer. Since 2001 Laparoscopy Hospital is supporting surgical residency and fellowship training by providing an opportunity for surgeons-in-training to utilize the Fellowship and Diploma program to study and to certify their basic skills in laparoscopy before going into clinical practice.
“We are proud to extend our coordination with Medical Council of India by having financial support to organise such international conference and laparoscopic workshop,” said, Prof. Dr. R. K. Mishra Indian President, World Association of Laparoscopic Surgeons. “This MCI grant will allow thousands of surgeons to get advantage from this conference and to develop in laparoscopic skills which will ultimately lead to new innovative surgical procedures and better patient outcomes,” added Flora.
The WALS has also developed structured training guidelines, developed by its international members and now jointly supported by the TGO University, is a comprehensive and validated educational module designed to teach the physiology, fundamental knowledge and technical skills required in basic and advanced laparoscopy that allows practice in a safe environment without putting patients at risk. Upon completion of the didactic and manual skills training portion of the course, participants take a proctored, two-part exam that covers cognitive knowledge, clinical judgment and technical skills.
Recognizing the importance of improving surgeon’s technical skills and enhancing patient safety, as well as the need for on-site training and testing, Medical Council of India has provided a generous, financial support to the WALS.
World Association of Laparoscopic Surgeons is a leading global organization to promote minimal access surgery among surgeons and gynaecologists all over world. WALS creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence.
About World Association of Laparoscopic Surgeons The World Association of Laparoscopic Surgeons (WALS) was founded in 1998 to foster, promote, support and encourage academic, clinical and research achievement in minimal access surgery. The Society has grown from fewer than 50 original members to almost 2,000 over 80 countries. WALS provides signature guidelines for training, standards of practice and granting of privileges which promote patient safety and the best clinical outcomes. Visit http://www.wals.org.uk for more information.
About the Laparoscopic Surgery Fellowship and Diploma Program
Developed by the World Association of Laparoscopic Surgeons (WALS) the Fellowship and Diploma in Minimal Access Surgery includes cognitive and hands-on skills training components, and a validated assessment focusing on the physiology, fundamental knowledge, and technical skills required in basic laparoscopic surgery. Visit laparoscopyhospital.com for details.
