Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 32 n° 312

Posts Tagged ‘device’

AVITA Medical Receives U.S. FDA Investigational Device Exemption Approval of Clinical Feasibility Study to Evaluate RECELL System for Vitiligo

Posted by fidest press agency su martedì, 31 dicembre 2019

AVITA Medical Limited (ASX: AVH, NASDAQ: RCEL), a regenerative medicine company with a technology platform positioned to address unmet medical needs in therapeutic skin restoration, announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) application to conduct a feasibility study evaluating the safety and effectiveness of the RECELL® Autologous Cell Harvesting Device (RECELL® System) for repigmentation of depigmented lesions associated with stable vitiligo.
“Vitiligo affects approximately 6.5 million people in the United States(i), rivalling the prevalence of psoriasis(ii); however, there are limited treatment options available to patients to permanently restore skin pigmentation,” said Dr. Mike Perry, AVITA Medical Chief Executive Officer. “We’re pleased with the FDA’s decision which allows us to begin our vitiligo study in the first half of 2020. Based on the outcomes of the feasibility study, we anticipate proceeding with a pivotal clinical trial to pursue FDA approval of the RECELL System as a cell-based repigmentation treatment option for stable vitiligo.”Vitiligo is a disease resulting in loss of color, or pigmentation, in patches of skin that impacts the quality of life for those living with the condition.(iii) There is currently no cure for vitiligo, nor a universally accepted method for limiting the spread of the disease. Although many treatments are being used for the management of vitiligo, they are often temporary with a high rate of recurrence.(iv)“This study expands on peer-reviewed, published effectiveness outcomes to confirm the feasibility of RECELL as a treatment for repigmentation in cases of stable vitiligo,” said Andy Quick, AVITA Medical’s Chief Technology Officer. “Given the RECELL System’s broad approval outside of the U.S., more than 1,000 vitiligo patients have already been treated globally and reported repigmentation.”AVITA Medical will collaborate with a leading medical center to conduct a pilot study with 10 patients who have vitiligo lesions that have been stable for at least one year. Areas of the vitiligo lesion will be randomly treated with slightly varying cell suspensions prepared using RECELL to confirm response rates and optimal suspension parameters.The randomized controlled study’s primary effectiveness measure is the percent area of repigmented skin 24 weeks after treatment, as evaluated by a clinician blinded to the treatment assignment. Additional effectiveness data collected over the course of the 24-week study will include degree of repigmentation achieved and patient rating of repigmentation.

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Cook Medical Applauds Congressional Action to Repeal the Medical Device Excise Tax

Posted by fidest press agency su martedì, 24 dicembre 2019

Cook Medical applauds the successful efforts of legislators from the U.S. Senate and House of Representatives to repeal the medical device excise tax. “Repealing the medical device tax will help bring new life-saving devices to patients around the world,” said Steve Ferguson, chairman of Cook Group, Cook Medical’s parent company. “We are grateful to our elected officials for this significant action to support patients who rely on medical technology.” After years of suspension, the tax was scheduled to be reinstated on January 1, 2020. Repeal of the tax prevents a negative impact on patient care, the evolution of healthcare and associated costs.“Repealing the tax also provides long-term assurance necessary for medical technology companies to continue investing in their employees and the research and development projects that lead to innovative new therapies for patients who need it most,” said Jennifer Kerr, president of Cook Research, and Medical Device Manufacturing Association board member.The medical technology industry employs more than two million people directly and indirectly across the United States. Cook Medical employs more than 7,000 people in the U.S. and 10,000 globally.

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The “Asia-Pacific Biopsy Device Market 2019-2027” report

Posted by fidest press agency su domenica, 16 giugno 2019

According to this research, the Asia Pacific biopsy device market shows an upward trend and is likely to exhibit a CAGR of 7.99% during the forecast period of 2019-2027.
India, China, Japan, South Korea, ASEAN countries, Australia & New Zealand and countries in rest of Asia-Pacific together form the market for biopsy devices in the APAC region.
In recent years, an increase in the number of cancer cases in APAC has intensified research in the disease to detect the condition early and to treat it by developing advanced solutions using biopsy tests. Furthermore, there exists a probability of leading vendors in the market shifting their base to the Asia-Pacific region to gain advantage of the lucrative proposition of cheaper land & material cost, easily available workforce and access to a vast patient base. This will make their solutions available to end-users at much lower costs. Therefore, economic developments and growing government support, with a possibility of biopsy vendors migrating their operational bases to the region, have opened new growth avenues for biopsy solution providers in the emerging markets.In countries such as China, India, and Thailand, oral cavity cancer is quite prevalent due to the use of smokeless tobacco products. Also, the stomach cancer rates are higher in these regions due to the high prevalence of Helicobacter pylori infection and probably due to dietary patterns. Over the forecasting period, the Asia-Pacific region with its broader customer base will dominate the global market in terms of demand for the biopsy procedure segment.

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University of Chicago Researchers Conduct Study of Unique Device to Lower High Blood Pressure

Posted by fidest press agency su giovedì, 13 giugno 2019

The University of Chicago Medicine’s Comprehensive Hypertension Center is participating in an FDA-approved pivotal trial of a novel catheter-based, non-surgical procedure to treat patients with drug-resistant hypertension. This study, called CALM-2 (Controlling And Lowering blood pressure with MobiusHD®), continues the study of the investigational MobiusHD device which was evaluated in an earlier proof-of-concept CALM-FIM which showed significant reductions in blood pressure through six months.The new, larger, multi-center CALM-2 clinical trial has been designed to assess the safety and effectiveness of this unique device as a possible solution for patients whose blood pressure is not controlled with prescribed medications.The research team at the Comprehensive Hypertension Center, led by world-renowned hypertension expert, professor of medicine and Center Director George Bakris, MD, specializes in the assessment and treatment of hard-to-treat hypertension. This includes the assessment of studies examining innovations in resistant hypertension.Specialized stretch-sensitive nerves called baroreceptors are located in the walls of the carotid arteries and play an essential role in the body’s natural blood pressure regulation. The MobiusHD system is used in the first minimally invasive procedure to utilize the baroreceptor mechanism to address uncontrolled hypertension.
The CALM-2 clinical trial, sponsored by Vascular Dynamics Inc., is targeting up to 300 drug-resistant hypertension patients at select medical centers around the U.S. and in the UK and Europe, including UChicago Medicine.

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CompuCom Launches Device as a Service Offering

Posted by fidest press agency su venerdì, 19 gennaio 2018

CompuCom_sCompuCom Systems, Inc. (“CompuCom®”), a leading provider of managed digital workplace services, today launched its Device as a Service (DaaS) offering, which combines hardware, managed services and device life cycle management into a single, fixed-cost service to help organizations lower total cost of ownership, increase user satisfaction and boost workplace productivity.Deploying and managing multiple devices from multiple vendors is often an overwhelming and expensive task for technology departments. CompuCom’s comprehensive DaaS offering covers the entire device life cycle, from procurement to deployment to disposition (disposal) – taking the stress out of acquiring, deploying and managing devices while gaining greater stability and visibility on technology costs – and enabling technology departments to focus on more strategic projects.CompuCom clients have said they want a consumption model that empowers end users to leverage current modern hardware, delivered in a near-zero-touch configuration, with a predictable monthly expense that their CFO can plan to. CompuCom’s DaaS solution addresses these issues in a sustainable and repeatable model, enabling the technology department to get back to helping their business users be more productive by delivering:End-to-end, fully managed support combined with device life cycle management, regardless of brand.
The ability to control IT costs with a predictable monthly price, giving technology departments the flexibility to scale up or down based on evolving workplace needs.
More brand choices and flexibility around device procurement, boosting employee satisfaction.
Increased employee productivity using the latest technology that is personalized for them.
Greater flexibility with cash flow and better visibility into the overall technology budget.
“Our ultimate goal is always to improve the customer experience, and DaaS represents another important way to achieve that,” noted CompuCom Chief Product Officer Ken Jackowitz. “Before, you’d have to find a hardware provider, a technology services company and a leasing agent. With the DaaS program, we do it all – procuring the best technology, avoiding penalties and delivering consistent managed services, no matter what brand of device you prefer.” (photo: CompuCom’s)

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