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  • unmet need
  • The device meets at least one of the following criteria for addressing an unmet need": there's no pre-existing alternate for the device, it utilizes a superior technology to what's currently on the market and is in the patient's best interest to make the device available as quickly as possible. (dscience.com)
  • FDA's
  • Varun Saxena, a news editor for Fierce Life Sciences , predicts the EAP will bring the FDA's validation process " more into line with its European counterpart, which regulatory [ sic ] approves critical devices years before the FDA . (dscience.com)
  • In May, an FDA review group will submit its assessment to the agency, and the agency may decide to make changes to the process then, said Jeff Shuren, director of the FDA's Center for Devices and Radiological Health. (medpagetoday.com)
  • The FDA has taken steps to expedite the review process for similar, integrated CGMs and make these types of systems available to patients as quickly as possible while also helping to ensure their safety and reliability," said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, 5 in a FDA press release. (endocrineweb.com)
  • The three products that have been chosen to participate in the FDA's 'Innovation Pathway' program are an implantable renal assist device (iRAD) being developed by the University of California, San Francisco, a wearable artificial kidney (WAK) in development by Blood Purification Technologies Inc. of Beverly Hills, Calif., and a hemoaccess valve system (HVS) that has been designed by Greenville, S.C.-based CreatiVasc Medical. (foxnews.com)
  • Accelerating Generic Drug Development explains the FDA's new policy and shows how to navigate the new pathway to approval. (fdanews.com)
  • obesity
  • The Food and Drug Administration (FDA) approved the TransPyloric Shuttle (TPS), an intragastric device that when implanted endoscopically was shown to be safe and effective in promoting significant weight reduction in individuals with obesity, 1,2 according to BAROnova, the device manufacturer. (endocrineweb.com)
  • The growing prevalence of type 2 diabetes (T2D), and factors such as increasing obesity, and greater life expectancy are driving the diabetes device market and creating greater opportunity for devices that automatically monitor blood glucose and deliver appropriate insulin doses. (endocrineweb.com)
  • CBS News reports about the implantable device called the Maestro Rechargeable System that could help those with severe obesity shed weight. (shespeaks.com)
  • 2018
  • The $692 billion fiscal 2018 National Defense Authorization Act (NDAA) contained a clause that would have given the Department of Defense (DOD) the power to greenlight "emergency use" treatments prior to FDA approval, on the grounds that it would allow potentially lifesaving treatments to be used more quickly. (fiercebiotech.com)
  • surgically
  • For example, instead of simply repairing or reinforcing damaged tissue like predicate devices, Menaflex is intended to stimulate the growth of new tissue to replace surgically removed tissue. (newsinferno.com)
  • Consumers about to receive surgically implanted devices will receive an 'Implant Card' clearly detailing all the product's characteristics and its potential adverse effects. (euractiv.com)
  • innovation
  • Gaurav has a strong passion for medical device innovation and is interested in disruptive medical technologies that not only solve an unmet clinical need, but also bring down the cost of healthcare. (medgadget.com)
  • Nearly all of the two dozen scientists, investors, and device industry insiders who testified at the hearing said the current 510(k) process is safe and expressed concerns about making companies work harder to get a 510(k) approval, saying it would stifle innovation. (medpagetoday.com)
  • Serge Bernasconi, the chief executive of Eucomed, the European medical technology industry association, said the deal will be a blow to patient access and medical device innovation in Europe. (euractiv.com)
  • adverse events
  • There were no serious unanticipated device-related adverse events. (medgadget.com)
  • Twenty-two percent of the total reported events were related to stimulation, hardware or procedure and three percent of all adverse events were serious device-related effects. (medgadget.com)
  • clinical trial
  • The company said a clinical trial of the device successfully hit all primary and secondary endpoints and showed that the product achieves fast, reliable biomechanical closure with rapid hemostasis. (fdanews.com)
  • Food and Drug Admin
  • Today, a study published in the Archives of Internal Medicine suggests most medical devices recalled for life-threatening or very serious hazards were cleared by the Food and Drug Administration through an expedited review process called 510(k), or were considered so "low risk" they were exempt from review entirely. (go.com)
  • Minneapolis - December 16 , 2014 -CVRx, Inc., a privately held medical device company, announced today that it has received Humanitarian Device Exemption (HDE) approval from the U.S. Food and Drug Administration (FDA) for its Barostim neo legacy device. (cvrx.com)
  • The US Food and Drug Administration (FDA) today approved an updated version of Abbott's MitraClip heart valve repair device, which serves as an alternative to open heart surgery. (mdmag.com)
  • Officials of Rockford-based Ascentia Health Inc. hope they are just weeks away from receiving U.S. Food and Drug Administration approval to begin marketing their Clayton Intra-Aural Device, or CID, an in-ear support that its inventor, audiologist Larry Clayton, hopes will create a major shift in how locking and malfunction of the jaw joint and its surrounding muscles is treated. (timesreporter.com)
  • A wearable and interactive blood glucose monitoring system-the Dexcom G6- is the first to gain Food and Drug Administration marketing approval for use with compatible diabetes management products, including insulin pumps and automatic dosing systems, and blood glucose meters. (endocrineweb.com)
  • We just wrote that the US Food and Drug Administration (FDA) announced that ReGen Biologic’s Menaflex Collagen Scaffold, an orthopedic device used in the knee, should not have been cleared for marketing in the United States. (newsinferno.com)
  • assessment
  • But Wednesday's committee vote went far beyond the Commission's original proposals, calling for the establishment of a new pre-marketing assessment system for high-risk devices, which would be identified on a case-by-case basis and only authorised with the approval of the European Commission. (yahoo.com)
  • For special high-risk devices, case-by-case checks will be conducted by a new expert body, the Assessment Committee for Medical Devices. (euractiv.com)
  • nausea
  • The trial did not find that the device effectively relieves symptoms associated with migraine, such as sensitivity to light and sound, or nausea. (medicalnewstoday.com)
  • serious harm
  • Diana Zuckerman, president of the National Research Center for Women and Families, said her group is currently conducting a review of 160 instances in which supposedly low-risk medical devices were recalled because they caused death or serious harm. (medpagetoday.com)
  • diagnostic
  • It's hugely beneficial in terms of the understandability of what the FDA is looking for," says Peter, who believes this guidance is going to be particularly useful for companies who are already in the process of designing this kind of diagnostic device. (dscience.com)
  • Shuren
  • The response from innovators exceeded our expectations and demonstrates that there is a desire from developers of innovative technologies for earlier and more collaborative agency interaction," said Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health (CDRH). (foxnews.com)
  • symptoms
  • The FDA includes examples of what would qualify a device as having no pre-existing alternate, including a "first-of-a-kind Parkinson's Disease testing device to differentiate symptoms from other diseases that may be less treatable. (dscience.com)
  • glucose
  • This is a monumental step forward as for the first time ever there is a device that completely eliminates the need for fingersticks, and is a very accurate tool that we as providers can download the patient's glucose data and review to optimize care," Daniel DeSalvo, MD, a pediatric endocrinologist at Texas Children's Hospital in Houston told EndocrineWeb . (endocrineweb.com)
  • Products
  • Waiting a decade for approval of treatments that can save lives on the battlefield when proven medical products are in use around the world is unacceptable," said Thornberry and Smith, who said they would call Gottlieb to testify before the committee early next year as the latest NDAA implementation takes shape. (fiercebiotech.com)
  • The FDA has approved more than 120,000 products through the process, ranging from simple devices such as condoms, to complex machines such as a robotic surgery system. (medpagetoday.com)
  • Although patient groups, consumer groups, lawmakers, and the media have turned the spotlight on the 510(k) process, it doesn't appear that any of those groups has looked at the data on how many products approved through the process have caused death or injury, and how that compares to other avenues for product approval. (medpagetoday.com)
  • delays
  • The FDA, by its own rules, had 90 days to respond to the application and Clayton said the company received an inquiry from the FDA this week which delays approval. (timesreporter.com)
  • balloon
  • There are currently four first-generation intragastric devices approved for use: two water filled balloons (Orbera and Reshape), one gas filled balloon (Obalon) and an aspiration device (Aspire Assist). (endocrineweb.com)
  • The drug-coated device consists of a stent and a catheter delivery system with a balloon, which inflates and deploys the stent into the coronary artery to keep it open. (medtechintelligence.com)
  • compliance
  • Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing. (fdanews.com)
  • company
  • The EU approval of the company's EndoRotor System, an endoscopic device that streamlines interventional gastrointestinal procedures used manage colon and esophageal cancer, is a milestone for the company. (wbjournal.com)
  • Company president and CEO Jeffery Ryan Jr. previously held several senior sales and marketing positions in the medical devices industry. (wbjournal.com)
  • How does a company know if their device qualifies? (dscience.com)
  • He said the company had considered manufacturing the devices locally but would probably outsource manufacturing in the early stages of business. (timesreporter.com)
  • Coole said a company in Pennsylvania that made the devices used in the clinical trials and a second company in Colorado have expressed interest in manufacturing the devices if the company decides to keep the rights and outsource production. (timesreporter.com)
  • Procedures
  • Over the past 25 years, physicians have become much more influential drivers of the overuse of many devices and procedures. (terrybryant.com)
  • We previously wrote that a report issued by the FDA’s Center for Devices last fall found that agency officials repeatedly deviated from procedures in approving Menaflex. (newsinferno.com)
  • prove
  • Because each device maker applying for a 510(k) has to prove only that their product is no worse than an existing product, theoretically, the quality of each new product erodes, like making a copy of an original, and then making a copy of that copy. (medpagetoday.com)
  • To apply for FDA approval, Ascentia was required to prove in clinical trials that its device - a small, hollow insert of medical grade polymers that is custom fitted to each patient's ear canal - could produce results comparable to those achievable with a bite splint. (timesreporter.com)
  • manufacturers
  • It is laborious and can take longer than some may like, especially the device manufacturers which are forced to spend their money on R&D and wait long periods of time before realizing profits after protracted FDA trial periods. (terrybryant.com)
  • This question brings up others, all having to do with the veracity of the new process and how much the public can trust the device manufacturers and, for that matter, the new "business-friendlier" FDA. (terrybryant.com)
  • In response, the EU's executive - the European Commission - has proposed increased monitoring of device manufacturers and tougher government oversight of the 80 or so mostly private Notified Bodies that currently decide on product safety. (yahoo.com)
  • scrutiny
  • The process has been the subject of scrutiny following several high-profile malfunctions of devices -- including a number of cardiac devices and leads -- that were given the fast-track okay by the FDA. (medpagetoday.com)