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The China Food & Drug Administration (CFDA) is planning to change its medical device regulation framework by proposing expanded requirements for medical device recalls and higher fines for medical device manufacturers that fail to issue such recalls. Under the new rules, a recall would be needed for devices that do not comply with the technical requirements that were inititally filed as part of the products’ Premarket Approval (PMA) application. Present-day guidelines mandate that domestic medical device manufacturers need to recall medical devices that present an unreasonable risk of harm to a patient's health and life during the course of prescribed use.
Xtant Medical received 510(k) clearance from the FDA to market its Xsert Lumbar Expandable Interbody System, a titanium expandable interbody device that expands in-situ. The device utilizes nanotextured endplate surfaces to allow osteointegration and includes an indication to be packed with autograft and allograft bone graft for bone contact and fusion.
Episurf announced the 150th implantation of its Episealer knee system, a patient-specific approach for the treatment of focal cartilage lesions. The procedures being with the Epioscopy process to visualize and assess cartilage damage, thus allowing Episurf to tailor every implant to a patient's specific anatomy and pathology.
MEDICREA announced that its patient-specific UNiD Rod technology has been used in over 1,000 procedures. The system allows surgeons to provide personalized pre-operative planning and patient-specific alignment of the spine. The company aims to improve patient treatment and reduce the need for revision surgeries, which lowers hospital costs.
Moximed announced that the first patient has been treated in a study using its Atlas System, a unicompartmental uploading implant. The system provides 30 lbs. of joint unloading in a smaller implant and provides an anatomically-guided surgical technique.
CAESAREA, Israel, Dec. 1, 2016 OrthoSpace, Ltd., a global innovative shoulder implant company, today announces that it has closed on a $7 million equity financing round. The funds will be used to support the ongoing US Investigational Device Exemption (IDE) FDA Study, build out the Company's commercial activities in Europe, South America and Asia and provide working capital. Existing investors, HealthpointCapital LLC, Smith & Nephew and TriVentures participated in this round, alongside a new investor, Johnson & Johnson Innovation - JJDC, Inc.
The Company's product, InSpace™, is an orthopedic biodegradable balloon system that is a simple, minimally invasive method that addresses unmet clinical needs in rotator cuff repair. InSpace is marketed in Europe, Israel, Russia and Hong Kong where 10,000 balloons have been implanted. It is indicated for patients who suffer from a rotator cuff injury, and it reduces shoulder pain and improves the range of motion. The procedure can be performed in an outpatient setting.
Itay Barnea, CEO of OrthoSpace, commented, "This is an exciting time for OrthoSpace. We are seeing great traction for InSpace among the European shoulder community where surgeons are grateful for a simple, effective option to treat rotator cuff injury. US surgeons have begun to learn about and gain experience with our device through participation in the US IDE Study, where enrollment is well underway. We are pleased to complete this financing to continue to invest in the Company's growth, and we look forward to offering InSpace in additional major markets worldwide."
OrthoSpace is a privately held medical device company located in Caesarea, Israel. The Company's product, InSpace, is an orthopedic biodegradable balloon system that is simple, safe and a minimally invasive method that addresses unmet clinical needs in rotator cuff repair. InSpace is CE Marked and commercialized in Europe, Israel, Russia and Hong Kong and has been granted an Investigational Device Exemption (IDE) to initiate a pivotal human clinical study of the system in the United States.
HealthpointCapital is a values-driven, research-based private equity firm exclusively focused on the orthopedic and dental device businesses. HealthpointCapital has more than $800 million of institutional capital under management and is the only firm of its kind to focus exclusively on the $45 billion worldwide orthopedic and dental device industry.
Smith & Nephew plc
Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people's lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2015 were more than $4.6 billion. Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).
TriVentures is a venture capital fund focused on investing in medical device and digital health technologies from seed stage to industry leaders. TriVentures has over $130 million under management dedicated to ventures primarily in Israel and the United States.
Johnson & Johnson Innovation - JJDC, Inc. (JJDC)
Johnson & Johnson Innovation - JJDC is the venture capital subsidiary of Johnson & Johnson that has been investing since 1973 in the medical device, diagnostic, pharmaceutical, and consumer health areas. JJDC's goal is to create opportunities that meet the strategic needs of its operating affiliates while providing visibility to innovative emerging technology, businesses and business models. JJDC invests in companies across the continuum from early stage seed investments to advanced stages of series venture management.
The China Food & Drug Administration (CFDA) is planning to change its medical device regulation framework by proposing expanded requirements for medical device recalls and higher fines for medical device manufacturers that fail to issue such recalls.
The proposed regulatory changes alter the standards for when a recall would be warranted in China for domestic manufacturers. Under the new rules, a recall would be needed for devices that do not comply with the technical requirements that were inititally filed as part of the products’ Premarket Approval (PMA) application.
Present-day guidelines mandate that domestic medical device manufacturers need to recall medical devices that present an unreasonable risk of harm to a patient's health and life during the course of prescribed use.
Stryker Enters Twenty-year Partnership with Indo UK Institute of Health's Medicity Program to Provide More Accessible Healthcare Solutions in India
Stryker entered a twenty-year collaboration partnership agreement with Indo UK Institute of Health's Medicity Program (IUIH) to develop solutions to enhance the quality of healthcare in the country of India and to make such services more accessible and affordable for patients.
The partnership aims to help deliver access of affordable hip and knee replacement systems and trauma products, and to streamline patient pathways and commercial services for Indian patients throughout their continuum of orthopedic care.
The IUIH project aims to replicate the National Health Service (NHS) system in U.K. in India to develop a new healthcare ecosystem which is available, affordable, accountable and appropriate to all. Under the IUIH program, eleven Indo UK Institutes of Health are being developed across eleven states in India. Each Indo UK Institute of Health will have a 1,000 bed NHS hospital, a nursing college, medical college, post graduate training center, implant manufacturing unit, eHealth center and accommodation.
Under the terms of the agreement, Stryker and IUIH will each invest in research and medical education. The partnership will provide sponsorship of a post-graduate training and education center at one of IUIH’s Medcities campuses, and a R&D collaboration at Stryker’s global technology center in India.