FDA Archives - Page 50 of 103 - Medical Design Sourcing

US buys 10 million additional courses of Pfizer’s COVID-19 pill Paxlovid

As COVID-19 infections in the U.S. hit new highs, President Joe Biden announced that the country would buy at least 20 million courses of Pfizer’s (NYSE:PFE) COVID-19 pill Paxlovid.

The government had planned on purchasing half as much of the drug, which won regulatory authorization in late December for certain patients with a high risk of developing severe COVID-19.

Biden also vowed that it had offered Pfizer additional resources to accelerate the manufacture of the drug.

The federal government is ready to use the Defense Production Act to spur quicker production of the drug.

Pfizer plans on providing roughly 10 million treatment courses to the government by the end of June. It plans on providing the additional 10 million courses by September 30.

Pfizer has previously announced that Paxlovid had an efficacy rate of 89% in a study focused on its potential to reduce hospitalization or death from COVID-19. The Phase 3 study involv…

FDA approves new MRI compatibility for Abbott’s Proclaim spinal cord stimulation system

Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system.

FDA’s expanded approval covers MRI compatibility for the Proclaim XR spinal cord stimulation (SCS) system with Octrode leads. The new approval lifts MRI restrictions for lead tip location and the amount of radiofrequency power that can be used as part of the normal operating mode of an MRI scan.

The Proclaim XR neurostimulation system combines low-energy therapy with a low-dosing protocol to provide chronic pain relief and preserve its battery. The platform received FDA approval in September 2019.

According to a news release, the FDA’s expanded labeling covers the majority of Proclaim XR patients, offering higher quality images with faster MRI scan times.

“MRIs have increasingly become an important tool helping doctors diagnose an illness or injury. They are particularly important for pat…

The top 5 drug discovery stories of 2021

Image courtesy of Pixabay

The pandemic continued to remake the pharma and biotech industry this past year. A handful of companies fared exceptionally well at commercializing COVID-19 therapies. This fact promises to lead to sizable shifts in the rankings of pharma leaders. These trends were not yet evident in our spring roundup of the 50 largest pharma companies, which drew revenue figures from the prior year. But in 2021, companies like Pfizer and Moderna sold tens of billions of dollars of COVID-19 vaccine alone. As a result of the ongoing pandemic, significant shifts are likely in 2022’s forthcoming ranking of pharma leaders.

Here, we provide an opportunity to review the 2021 pharma landscape, including stories that received the most attention on social media.

1. Pharma 50: The 50 largest pharmaceutical companies in the world

The top 50 largest pharmaceutical companies raked in $851 billion…

FDA authorizes expanded use of Pfizer-BioNTech vaccine boosters

With the U.S. facing the biggest surge of COVID-19 infections to date, the FDA has decided to amend the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to cover adolescents aged 12 to 15 and for some immunocompromised children between the ages of 5 and 11. The agency has also reduced the window between the second and third doses from six to five months.

“With the current wave of the omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask-wearing and social distancing in order to effectively fight COVID-19,” said Acting FDA Commissioner Dr. Janet Woodcock.

To arrive at its decision, FDA analyzed real-world data from Israel, including 6,300 individuals between the ages of 12 and 15 who received a booster dose of the BNT162b2 vaccine at least five months after receiving a second dose.

The authorization for certain immunocompromised child…

FDA grants EUA to Siemens Healthineers’ over-the-counter rapid COVID-19 test

[Image from Siemens Healthineers]Siemens Healthineers (ETR:SHL) announced that it received FDA emergency use authorization (EUA) for its Clinitest COVID-19 diagnostic.

Tarrytown, New York-based Siemens Healthineers can now offer the Clinitest rapid COVID-19 antigen self-test over the counter as the need for COVID-19 testing rises in the U.S.

According to a news release, the company designed the nasal swab test to aid in the rapid detection of SARS-CoV-2 (the virus causing COVID-19) with visually read test results delivered in 15 minutes. Authorization covers self-testing for individuals aged 14 years and older or adult-collected samples from individuals aged two to 13.

Siemens Healthineers expects the test to be made available in January, having secured dedicated production capacity for U.S.-bound tests in the range of tens of millions per month.

“Undetected COVID-19 exposure is a major driver of community spread. With the Clinitest rapid COVID-19 an…

FDA approves injectable atopic dermatitis treatment from LEO Pharma

LEO Pharma announced today that it received FDA approval for its Adbry injection treatment for moderate-to-severe atopic dermatitis.

Ballerup, Denmark-based LEO Pharma designed its Adbry injection for treating atopic dermatitis in adults aged 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Get the full story at our sister site, Drug Delivery Business News.

FDA clears Nobel Biocare’s N1 implant system

Envista (NYSE:NVST) announced today that the FDA cleared the Nobel Biocare N1 implant system of instruments, prosthetic components and surgical protocols.

The N1 system includes an implant designed for immediate placement and predictable insertion torques, providing a trioval conical connection for the abutment to slide into place. Additionally, the system has an emergence profile designed for soft tissue maintenance.

It includes the OsseoShaper implant for redefining site preparation and reshaping implantology with optimized workflows, greater patient comfort and faster treatment times, according to a news release. The OsseoShaper “shapes” the osteotomy at a low speed and without irrigation to reduce noise and vibration compared to conventional drilling protocols.

“The demand for high-quality patient-centric solutions is higher than ever and the Nobel Biocare N1 system enables clinicians to set a new standard in personalizing, digitizi…

FDA issues draft guidance for transitioning medical devices granted EUAs during pandemic

The FDA is proposing that it give medical device makers about half a year’s notice before terminating emergency use authorizations post-pandemic.

That was one of the major takeaways from the draft guidance that the FDA released today. It considers ways to transition medical device regulation once COVID-19 moves from a pandemic to an endemic phase. There are presently hundreds of medical devices sold in the U.S. under EUAs issued during the pandemic.

Get the full story at our sister site, MassDevice.

FDA issues draft guidance for transitioning medical devices granted EUAs during pandemic

The FDA is proposing that it give medical device makers about half a year’s notice before terminating emergency use authorizations post-pandemic.

That was one of the major takeaways from the draft guidance that the FDA released today. It considers ways to transition medical device regulation once COVID-19 moves from a pandemic to an endemic phase. There are presently hundreds of medical devices sold in the U.S. under EUAs issued during the pandemic.

FDA said its draft guidance aims to help prepare manufacturers and other stakeholders for the orderly and transparent transition to the eventual resumption of normal operations in a post-pandemic world.

The guidance floats the notion of the advance notice of termination of each emergency use authorization declaration being published in the federal register 180 days before the day on which the FDA EUA declaration is officially terminated. During the 180-day period, manufacturers of devices with EUAs must…

FDA approves Philips’ laser-based device for removing inferior vena cava filters

The FDA today announced the authorization of the first laser-based device for removing IVC filters, developed by Royal Philips (NYSE:PHG).

Authorization was given through the de novo pathway, with Philips’ device receiving FDA breakthrough device designation for the removal of IVC (inferior vena cava) filters.

Philips designed the device for patients who have an IVC (inferior vena cava) filter inserted into the largest vein in the body to capture blood clots and prevent them from traveling to the lungs. The new device — Philips’ CavaClear laser sheath — removes tissue to facilitate the detachment of an IVC filter during retrieval when previous methods of removal have failed.

The Amsterdam-based company designed the device to facilitate the detachment of the firmly adherent IVC filters from the IVC wall using ultraviolet laser energy to remove a small amount of the tissue, with the device made for use in conjunction with conventional snare dev…

FDA says there’s a cybersecurity vulnerability with Apache’s Log4j

[Image from Pixabay]

The FDA is raising awareness about a cybersecurity vulnerability related to Apache’s Log4j — used to log security and performance information for many software applications, including in the medical device space.

The vulnerability involves Apache’s Log4j software library, versions 2.0-beta9 to 2.14.1.

The FDA said in a statement posted on December 17 that it does not know of the Log4j problems causing a medical device adverse event. However, there is still a risk that the situation could make a medical device unavailable, or an unauthorized user could remotely impact safety and effectiveness.

The Cybersecurity and Infrastructure Security Agency (CISA) agency has established a website with more information, including recommendations to address the vulnerability. The FDA encourages manufacturers to communicate with customers about the problem and coordinate with the …

FDA clears Bioventus’ neXus BoneScalpel Access system

Bioventus (NSDQ:BVS) announced today that it received FDA 510(k) clearance for its neXus BoneScalpel Access handpiece.

Durham, North Carolina-based Bioventus said in a news release that the neXus ultrasonic surgical aspirator system — a next-generation integrated ultrasonic surgical platform driven by a proprietary digital algorithm — powers the BoneScalpel Access device.

The neXus system combines all features of soft and hard tissue removal in a single, fully integrated offering, Bioventus said. Its indications under FDA 510(k) clearance include use in the fragmentation and aspiration of soft and hard tissue in neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecology and more.

Bioventus plans to launch BoneScalpel Access — a product the company picked up through its recent acquisition of Misonix — in 2022. The neXus ultrasonic surgical aspirator s…