Sentences with phrase «medical approval for»

And even when magazines seek medical approval for articles, they may not apply the same standards to their other content.

Not exact matches

Launched in 2012, Edison Nation Medical allows entrepreneurs to submit as little as a back - of - the - napkin idea for a medical device, and then its team of manufacturers, attorneys, and health care specialists takes care of the rest, from patenting and FDA approvals to licensing and distriMedical allows entrepreneurs to submit as little as a back - of - the - napkin idea for a medical device, and then its team of manufacturers, attorneys, and health care specialists takes care of the rest, from patenting and FDA approvals to licensing and distrimedical device, and then its team of manufacturers, attorneys, and health care specialists takes care of the rest, from patenting and FDA approvals to licensing and distribution.

The approval was based on two clinical trials of the device and lowers the barrier of entry for other similar devices, by establishing criteria that classify these systems as moderate risk medical devices, the FDA announced.

The Food and Drug Administration (FDA) is crafting a special unit to focus on digital health and tackle thorny issues such as creating an appropriate approval / clearance pathway for mobile medical apps.

The FDA approval process for medical devices is insane.

The bill aims to speed up the approval for drugs and medical devices through a variety of tweaks to the Food and Drug Administration (FDA).

Meanwhile, Frayne's applications for accelerated patent approval (due to his medical condition) were approved.

While medical marijuana has been legal in California for two decades — accounting for roughly $ 2 billion in annual sales — state residents must wait until January 2018 before they are able to legally buy marijuana in California without a doctor's approval.

«This approval will open the floodgates for these kinds of therapy to be used in many different leukemias, lymphomas, solid tumors, myelomas,» Dr. Prakash Satwani, a pediatric hematologist - oncologist at Columbia University Medical Center, told Business Insider.

While the Eve Kit has yet to officially launch to the public, Eve Medical has secured Health Canada approval for its product and already has health authorities using it for in - clinic self - sampling in 12 different countries.

The sponsor of a material threat medical countermeasure application that receives a priority review voucher under this section may transfer (including by sale) the entitlement to such voucher to a sponsor of a human drug for which an application under section 505 (b)(1) or section 351 (a) of the Public Health Service Act will be submitted after the date of the approval of the material threat medical countermeasure application.

Health insurer Aetna Inc expects approval of the Portola drug to gradually increase use of Xarelto and Eliquis, said Edmund Pezalla, Aetna's national medical director for pharmaceutical policy and strategy.

Nokia's idea was to collect health data from users, with their approval, and use it for its own medical business, WellCare.

Such risks and uncertainties include, but are not limited to: our ability to achieve our financial, strategic and operational plans or initiatives; our ability to predict and manage medical costs and price effectively and develop and maintain good relationships with physicians, hospitals and other health care providers; the impact of modifications to our operations and processes; our ability to identify potential strategic acquisitions or transactions and realize the expected benefits of such transactions, including with respect to the Merger; the substantial level of government regulation over our business and the potential effects of new laws or regulations or changes in existing laws or regulations; the outcome of litigation, regulatory audits, investigations, actions and / or guaranty fund assessments; uncertainties surrounding participation in government - sponsored programs such as Medicare; the effectiveness and security of our information technology and other business systems; unfavorable industry, economic or political conditions, including foreign currency movements; acts of war, terrorism, natural disasters or pandemics; our ability to obtain shareholder or regulatory approvals required for the Merger or the requirement to accept conditions that could reduce the anticipated benefits of the Merger as a condition to obtaining regulatory approvals; a longer time than anticipated to consummate the proposed Merger; problems regarding the successful integration of the businesses of Express Scripts and Cigna; unexpected costs regarding the proposed Merger; diversion of management's attention from ongoing business operations and opportunities during the pendency of the Merger; potential litigation associated with the proposed Merger; the ability to retain key personnel; the availability of financing, including relating to the proposed Merger; effects on the businesses as a result of uncertainty surrounding the proposed Merger; as well as more specific risks and uncertainties discussed in our most recent report on Form 10 - K and subsequent reports on Forms 10 - Q and 8 - K available on the Investor Relations section of www.cigna.com as well as on Express Scripts» most recent report on Form 10 - K and subsequent reports on Forms 10 - Q and 8 - K available on the Investor Relations section of www.express-scripts.com.

No medical exam policies often provide same day coverage, or may take up to five business days, while traditional policies can take several weeks for approval.

Many of the state's thousand - plus existing medical marijuana dispensaries are eligible for state permits to sell either medical or recreational marijuana under new regulations — but only if they also receive local approval.

Investments in fast - growing industries like the technology and healthcare sectors (which have historically been volatile) could result in increased price fluctuation, especially over the short term, due to the rapid pace of product change and development and changes in government regulation of companies emphasizing scientific or technological advancement or regulatory approval for new drugs and medical instruments.

Investments in fast - growing industries like the technology and health care sectors (which have historically been volatile) could result in increased price fluctuation, especially over the short term, due to the rapid pace of product change and development and changes in government regulation of companies emphasizing scientific or technological advancement or regulatory approval for new drugs and medical instruments.

is that off - label uses for medications are supported by medical trials / testing, but lack of FDA - approval means the drug manufacturers can not * advertise * the off - label uses?

Approval for the study was granted by the University and Medical Center Institutional Review Board.

The dentistry issued a statement of sympathy for Mykel and his parents and said that it would be premature to comment on any specifics until outside medical experts finish their review, but they said they have used general anesthesia more than 1,900 times for pediatric patients in the last three and a half years without incident, and that they contract with a board - certified anesthesiologist who follows all protocols including pre-operative check and approval by the child's primary care physician before putting the child under anesthesia.

It is important for you to discuss any medical issues with your doctor prior to your consult, and to get their approval for 8 + hours of night sleep.

Cuomo clarified in his approval memo, however, that the law «does not remove an insurer's ability to review breast tomosynthesis for medical necessity.»

«Our gratitude goes to Chairman Gottfried, Assemblywoman Paulin, the other sponsors of the bill, and the members of the Assembly Health Committee for this historic, first - ever approval of the Medical Aid in Dying Act, which would allow terminally ill, mentally competent, adult patients to self - administer prescribed medicines if their suffering becomes unbearable,» David Leven, the executive director of End of Life Choices New York, said in a statement.

When it comes to the hot - button policy issues at the Capitol, most voters support a broad program for medical marijuana, but approval is inching up for the governor's more limited pilot program.

Other notable contract and payment approvals announced Monday include a $ 1.9 million contract with Bio-Tech Medical Software Inc. for a medical marijuana seed - to - sale tracking system and an $ 884,000 payment to the Albany Convention Center Authority for the Albany Capital Center PMedical Software Inc. for a medical marijuana seed - to - sale tracking system and an $ 884,000 payment to the Albany Convention Center Authority for the Albany Capital Center Pmedical marijuana seed - to - sale tracking system and an $ 884,000 payment to the Albany Convention Center Authority for the Albany Capital Center Project.

Medical marijuana will soon be available for dropoff at patients» front doors, with the New York Health Department's approval of its first home delivery program.

It was also alleged that Osinbajo travelled to London, where Buhari is currently on medical vacation, to get approvals for some decisions.

A proposal to amend city law to allow a shooting range to operate in a former medical practice on Prince Street in Midtown will go to the full Common Council for approval.

Patients who were approved in other states for medical marijuana could not carry that approval into New York, under Cuomo's plan.

The county also prematurely budgeted $ 17.8 million in revenues for 2011 from the planned sale of its nursing home and medical facility, operated under the home and infirmary fund, to a proposed public benefit corporation (PBC) to be established with state approval.

The largest transaction was ILDC approval of a $ 34 million of tax exempt bonds with 134 High Street, LLC for construction of an 1,800 - vehicle parking ramp on the Buffalo Niagara Medical Campus (BNMC).

The letter, which was written by Osinbajo on June 17 when he was Acting president while President Muhammadu Buhari travelled abroad on medical leave, also sought the lawmakers» approval for the appointment of Ndasule Moses, Lawan Mamman, Galandanci Imam Najib, and Adeleke Abebayo Rafiu, as members of the EFCC board.

TouchNetworks is still seeking Food and Drug Administration approval for the medical vest, a process that could delay its medical use for several years.

But early approval left medical centers scrambling to establish treatment programs, which became more urgent when the FDA approved the drug for all SMA patients in December 2016, Burgart said.

President John F. Kennedy honors FDA medical officer Frances Kelsey in 1962 for her work blocking U.S. approval of thalidomide.

The decision was made after a scientific review by the Food and Drug Administration (FDA) concluded that the evidence for the medical benefits of marijuana did not meet their standards for new drug approval.

None of the consumer kits have officially undergone the rigorous testing process that a drug or medical device must undergo for approval by the U.S. Food and Drug Administration, and the purchaser has only the manufacturer's claim that it works for its intended use.

Like drugs, medical devices must receive regulatory approval before they can be marketed and sold — but the regulatory hurdles and costs are much lower for devices than they are for drugs.

The paper inflamed public fears about vaccines, but it was retracted in 2010 after the UK General Medical Council (GMC) concluded that Wakefield had a charge of serious professional misconduct to answer, in part because it found that his team did not have proper ethical approval for tests performed on the children.

By planting this paper in the medical literature, the company was preparing for the approval process by highlighting in the medical literature the deficiencies of the best - selling generic that the new drug would compete with.

When an investigational prescription drug shows promise for treating a serious illness or filling an unmet medical need, the Food and Drug Administration (FDA) has special programs available to expedite its clinical testing and approval.

Joseph Fins, a professor of medicine and medical ethics at Weill Cornell Medical Center, applauds the approval and says, «This test is an advance for triaging CT scans.medical ethics at Weill Cornell Medical Center, applauds the approval and says, «This test is an advance for triaging CT scans.Medical Center, applauds the approval and says, «This test is an advance for triaging CT scans.»

The FDA's medical reviewer's recommendation for approval says, in part, that more trials before approval would «significantly delay effective therapy,» which not only reduces body weight but exerts favorable effects on blood pressure and myocardial oxygen for «patients with a serious disease condition with few treatment options.»

It calls for the hospital to be more independent from KI, especially in hiring decisions, and recommends additional training for staff on regulations surrounding ethics approval and new medical products.

But, this type of study is not always used when testing new medical products for FDA approval, and it is particularly rare for new devices, which are subject to different regulatory procedures from prescription drugs.

Califf, whom critics have labeled an industry insider for his role overseeing large company - funded trials at Duke University Medical Center in Durham, North Carolina, will take the helm as the agency faces pressure from Congress to speed the approval of medical products to paMedical Center in Durham, North Carolina, will take the helm as the agency faces pressure from Congress to speed the approval of medical products to pamedical products to patients.

In other health - related recommendations, the plan calls for legal and regulatory action to speed up approval of new drugs and medical devices.

Under the system to provide medical treatment to end - stage heart failure patients, a group that is ineligible for heart transplantation, in response to their requests, Osaka University Hospital gained the nation's first approval for its use as a medical device on February 20, 2017.

Pharmaceutical companies, medical - device manufacturers, and clinical - research organizations (CROs) all employ writers to prepare regulatory documents used to seek U.S. Food and Drug Administration (FDA) approval for drugs and devices.