Search Results for “FDA” – Page 56 – media

FDA warns of COVID-19 antigen test false positives as report flags Quidel on accuracy

FDA has issued an alert to clinical labs and healthcare providers about the potential for COVID-19 antigen tests to deliver false positives after receiving reports from nursing homes and other settings. The agency’s Tuesday notice reminds users to follow the instructions, noting that improper storage and reading the results at the wrong time can lead to false results. At the same time, the agency said false positives could be an inevitable consequence of using tests with specificities below 100%. If a test with 98% specificity is used to screen a population in which 10% of people are infected, two out of every 10 positive results will be false. The FDA’s warning comes a day after The New York Times reported on a University of Arizona study raising concerns about the ability of a Quidel rapid antigen test to detect asymptomatic cases. The study found Quidel’s test produced more false positives than positives confirmed by the gold standard PCR tests. The potential for antigen tests ...
- Source: drugdu
- 384
- November 9, 2020
Covid-19
FDA Approves First Treatment for COVID-19

For Immediate Release: October 22, 2020 Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval. This approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) originally issued on May 1, 2020. In order to ensure continued access to the pediatric population previously covered under the EUA, the FDA revised the EUA for Veklury to authorize the drug’s use for treatment of suspected or laboratory confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to ...
- Source: drugdu
- 258
- October 26, 2020
Covid-19
Remdesivir becomes first Covid-19 treatment to receive FDA approval

By Maggie Fox, CNN Updated 5:36 PM ET, Thu October 22, 2020 (CNN) The US Food and Drug Administration has approved remdesivir for the treatment of coronavirus infection, the drug’s maker, Gilead Sciences, said Thursday. It is the first drug to be approved for treating Covid-19. The drug, sold under the brand name Veklury, has been used under emergency use authorization since May. The antiviral has shown, at best, a modest benefit for coronavirus patients. But there is little else available. “In the United States, Veklury is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization,” the company said in a statement. “Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.” Earlier this month, a World Health Organization-sponsored global study found remdesivir ...
- Source: drugdu
- 244
- October 23, 2020
Covid-19
AZ’s Farxiga Gets FDA Priority Review For Heart Failure

AstraZeneca has got off to a strong start in 2020, with the FDA granting a fast review for its diabetes drug Farxiga in heart failure and China approving Lokelma for hyperkalemia.
- Source: https://scrip.pharmaintelligence.informa.com/SC141424/AZs-Farxiga-Gets-FDA-Priority-Review-For-Heart-Failure
- 1,395
- January 8, 2020
AstraZeneca Farxiga FDA Lokelma
FDA approved Infusion Set with Needle

Intravenous infusion is the most potent form of almost all medicines available to treat diseases. This holds true for medicines given in acute conditions and hence, the mode of administration chosen by hospitals is intravenous. Intravenous infusions are administered into the veins via infusion sets that work on the principle of gravity. These infusion sets usually consist of three parts, namely the drip chamber, the tube, and the needle holder. Different infusion sets with slight variations to suit the requirements of different patients are available in the market. Farmasino Pharmaceuticals (Jiangsu) Co., Ltd. is one of the infusion set suppliers on Ddu (Drugdu.com), the leading global pharmaceutical and medical devices online B2B platform. It supplies CE, ISO and FDA approved sterilized disposable infusion set with a needle in wholesale quantities on Ddu. These infusion sets come with a warranty of 1 year. They are also fitted with a flow ...
- Source: drugdu
- 1,830
- October 19, 2018
BIOTRONIK PK Papyrus Stent gets FDA approval for treatment of Acute Coronary Perforations

The PK Papyrus sheathed coronary stent system developed by BIOTRONIK to be used in the emergency treatment of acute coronary perforations in original coronary vessels or those that are bypassed grafts, attained FDA approval under the Humanitarian Device Exemption. It was already approved in Europe in 2013 and is the only French coronary stent approved in the U.S. It is one of its kinds as it is able to traverse vessels with diameters as narrow as 2.5 mm to 5.0 mm. The company touts it as an alternative to bypass grafts as it is made in 17 differing sizes. The covering of the stent is electrospun and is very thin made from polyurethane. This covering prevents the blood from flowing along its sides and its flexibility also enables the stent to transform its shape when delivering and placing it inside the vessel. “In rare cases of a coronary perforation, time ...
- Source: drugdu
- 386
- September 22, 2018
FDA issues new guidelines to prescribe immediate-release opioids

September 2018 saw a new broadened Risk Evaluation and Mitigation Strategy (REMS) for prescribing immediate-release opioid analgesics in out-patient departments, released by the FDA which doctors need to take note of. Extended-release and long-acting opioids have been under REMS since 2012 but the new guidelines include them too. As per the new REMS program, health care professionals handling pain management need to undergo training which includes physicians, nurses and pharmacists as well. This requirement has been introduced for the first time. The study material should also include information pertaining to alternatives to opioid drugs for mitigation of pain, as per the new REMS. A new booklet containing updated educational matter has already been approved by the FDA. A new label displaying information for the medical professional’s knowledge which is a requirement of the new REMS is under the process for attaining approval from the FDA. “Our new effort is aimed at ...
- Source: drugdu
- 820
- September 20, 2018
AliveCor gets FDA breakthrough status for Hyperkalemia diagnosis

Hyperkalemia is defined as the condition where there would be a higher potassium level in blood. The potassium level goes higher due to chronic kidney disease and type 1 diabetes, suffered by millions of people. Irregular heartbeat is the common symptom of hyperkalemia. A blood sample is required to detect the potassium level till date. But a Silicon Valley start-up company named AliveCor along with the doctors from Mayo Clinic have developed a novel technology, where the blood sample is not required. Just by looking at the electrocardiogram (ECG) pattern which records the electric signals of the heart, the level of potassium can be detected. Hence, the U.S. Food and Drug Administration had given ‘breakthrough device’ designation on 10th September 2018 for a novel way of potassium level measurement. Vic Gundotra, the CEO of AliveCor, said “It was a pie-in-the-sky idea that we could use AI to see something like ...
- Source: drugdu
- 1,325
- September 13, 2018
Baxter’s new Actifuse Flow bone graft alternative gets FDA nod.

Actifuse Flow, Baxter International’s new synthetic bone graft surrogate from its osteobiologics surgery series, wins FDA approval for implementation in orthopedic surgeries. In order to reach tine bony cracks and gaps of the skeletal structure, the new bone graft alternative is designed to reach these exact cranny locations. It is delivered via a syringe already containing it to speed-up bone growth. No preparatory procedure or mixing is needed to use this bone graft substitute and it maintains its fluid consistency during the surgery. The surgical products manufacturer’s Actifuse Bone Graft Alternative constituting Actifuse Flow implements the silicate-substituted technology for bone formation via raised levels of silicon. It becomes an ideal candidate for minimally invasive surgical procedures as the syringe facilitates the start and stop of flow to deliver the precise amount of substance. This also enables it to compact small done deformities as well as the intricate disorder of bone ...
- Source: drugdu
- 1,063
- September 13, 2018
FDA approves Masimo’s Tiny Breathing Sensor for Paediatric patients in U.S.

The RAS-45 acoustic respiration sensor, developed by Masimo, to function along with the Rainbow Acoustic Monitoring (RAM), was approved by the FDA for use in neonates and infant patients. A minimum weight of 22pounds/10 kgs of the baby was required earlier to be eligible for use of RAM sensors. This requirement is no longer necessary for the new sanction that enables a convenient monitoring of the rate of respiration in very young pediatric patients. This is possible because the maximum respiration rate in the sensor has been raised to 120 breaths per minute with an excellent precision between +/- breath every minute. The sensor can be stuck on to the child and it is fitted with a microphone mimicking device that spots respiration sounds from other background sounds. Its clarity enables pediatricians to listen to the breathing of the infant as if he/she is listening via a stethoscope. The sensor ...
- Source: drugdu
- 1,131
- September 12, 2018

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.