FDA Archives - Page 33 of 103 - Medical Design Sourcing

FDA advisors unanimously back Moderna and Pfizer COVID-19 vaccines in young children

An FDA panel voted 21 to 0 to authorize the Pfizer/BioNTech and Moderna COVID-19 vaccines in children between the ages of 6 months and 4 years of age.

Children under the age of 5 constitute the only age group that has not been eligible to be vaccinated against COVID-19.

“I know there are a lot of very relieved parents,” said Dr. Jon Portnoy, a voting member of the Vaccines and Related Biological Products Advisory (VRBPAC) panel. “I understand why parents are very nervous and fearful of doing normal activities, especially if their child actually catches COVID.”

The potential availability of two COVID-19 vaccines for young children “will certainly alleviate a lot of [parents’] concerns,” he added.

VRBPAC member Dr. Ofer Levy emphasized the importance of choice for parents with young children.

“They can partner with their pediatrician to make a decision,” Levy said. Vaccines are a vital tool for fighting COVID-19, especially in communiti…

New authorized Roche COVID-19 test can also detect viral loads

Roche announced today that it received FDA emergency use authorization (EUA) for its cobas SARS-CoV-2 Duo diagnostic.

Authorization covers the cobas SARS-CoV-2 Duo on the fully automated cobas 6800/8800 systems, expanding Roche’s COVID-19 portfolio and representing the first automated, RT-PCR assay for the in vitro qualitative and quantitative detection of SARS-CoV-2 RNA in nasal and nasopharyngeal swab specimens.

The assay performs quantitation of SARS-CoV-2 RNA levels in the connected specimen, while only the qualitative result of cobas SARS-CoV-2 Duo is intended for use as an aid in the diagnosis of SARS-CoV-2 infection in patients suspected of COVID-19 by their healthcare provider.

Basel, Switzerland-based Roche said in a news release that the potential benefits from reporting a standard viral load along with the qualitative result may help clinicians assess and monitor infected patients across laboratories over time.

The company plans t…

FDA seeking innovations to move beyond heater-cooler device problems

The FDA issued a notice today saying that it is working to evaluate new strategies to mitigate infections associated with heater-cooler devices.

According to the notice, the administration is collaborating with professional societies, public health partners, heater-cooler manufacturers, and experts on the matter surrounding the heater-cooler devices used during medical and surgical procedures to warm or cool a patient. Although fluid in the circuits does not directly contact the patient, there is the potential for contaminated fluid to enter other parts of the device or transmit bacteria through the air through the device’s exhaust vent or other unsealed openings, reaching the environment and the patient.

Get the full story at our sister site, Medical Design & Outsourcing.

FDA seeking innovations to move beyond heater-cooler device problems

The FDA issued a notice today saying that it is working to evaluate new strategies to mitigate infections associated with heater-cooler devices.

According to the notice, the administration is collaborating with professional societies, public health partners, heater-cooler manufacturers, and experts on the matter surrounding the heater-cooler devices used during medical and surgical procedures to warm or cool a patient. Although fluid in the circuits does not directly contact the patient, there is the potential for contaminated fluid to enter other parts of the device or transmit bacteria through the air through the device’s exhaust vent or other unsealed openings, reaching the environment and the patient.

Previous issues have arisen around these devices, including with LivaNova’s 3T Heater-Cooler device. In 2016, the FDA warned patients and doctors about the risk of a type of bacterial infection associated with the device. Later that year, the U.S. …

FDA approves Olumiant as first systemic therapy for baldness form

The FDA has announced that it has approved Lilly’s Olumiant (baricitinib) oral tablets to treat adults with severe alopecia areata, a form of baldness resulting from the body attacking its hair follicles.

Manifesting as patchy baldness, alopecia areata affects more than 300,000 people in the U.S.

The incidence of alopecia areata is growing.

“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Dr. Kendall Marcus, director of the division of dermatology and dentistry in the FDA’s Center for Drug Evaluation and Research, in a news release. “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”

FDA first approved Olumiant in 2018 for rheumatoid arthritis. In 2022, the drug won an indication for COVID-19 in some hospitalized COVID-19 patients.

FDA concludes Pfizer-BioNTech vaccine likely safe and effective in kids under 5

In the U.S., COVID-19 vaccines are widely available to all age groups apart from children under the age of five. However, that could change this month now that FDA has signaled that three doses of the Pfizer-BioNTech (NYSE:PFE/Nasdaq BNTX) COVID-19 vaccine are likely effective against COVID-19 in an analysis ahead of a June 15 Vaccines and Related Biological Products Advisory Committee meeting.

Pfizer and BioNTech, like Moderna (Nasdaq:MRNA), are seeking emergency use authorization (EUA) to use their respective vaccines in children aged six months to four years of age.

Pfizer has provided FDA with new reactogenicity and immunogenicity data from the ongoing Phase 1/2/3 C4591007 trial.

In late May, Pfizer submitted a request to FDA to allow the use of three 3-μg doses of their BNT162b2 vaccine in the same demographic.

In April, Moderna announced that it had filed paperwork seeking EUA for two 25-μg doses of its mRNA-1273 vaccine in young children. Read more

FDA clears Lensar Ally cataract treatment system

[Image from Lensar]Lensar (Nasdaq:LNSR) announced today that it received FDA 510(k) clearance for its next-generation Ally system.

Orlando, Florida-based Lensar designed the Ally adaptive cataract treatment system to enable cataract surgeons to complete the femtosecond-laser-assisted cataract (FLACS) procedure seamlessly in a single, sterile environment.

According to a news release, the company intends to deliver the first Ally systems to surgeons in the third quarter of this year by way of a controlled and targeted initial launch, which will be followed by wide availability of the system to cataract surgeons in 2023.

Lensar said in the release that Ally has a small footprint with enhanced ergonomics, providing surgeons with a unique opportunity to improve efficiencies in any operating room or an in-office surgical suite. Ally represents the first cataract surgery platform to use adaptive intelligence to automatically determine cataract density, optimize fr…

New medical device user fees agreement passes House

[Image from Unsplash]The U.S. House last night voted 392-28 to pass Medical Device User Fee Amendments that reflect the latest agreement between the FDA and the medtech industry.

The House bill on FDA amendments that passed, sponsored by Rep. Ann Eshoo (D-California), drew from the MDUFA V agreement between the FDA and medical device industry. It reauthorized the FDA user fee programs for prescription drugs, medical devices, generic drugs and biosimilar through the fiscal year 2027. It also required the development of action plans and related reporting to increase the diversity of participants in clinical trials.

Get the full story on our sister site Medical Design & Outsourcing.

AI-powered scope developer says new FDA clearance opens the door for telehematology

The Scopio X100 (left) and new X100HT [Image courtesy of Scopio Labs]

Scopio Labs today announced FDA 510(k) clearance for its X100HT, which features a new slide loader that automatically prepares samples and feeds them into the digital blood scanner for AI-powered analysis.

The Tel Aviv-based digital microscope developer said the technology eliminates the need for manual microscopic examination when reviewing white and red blood cells and estimating platelet counts.

Based on the X100 that was 510(k)-cleared by the FDA in 2020, the X100HT has a slide loader with three cassettes that can each hold 10 slides. After the slides are placed in the cassettes and inserted into the slide loader, the slide loader automatically applies mounting media and a glass cover slip onto the slides and sequentially inserts them into the scanner for processing, according to the FDA’s decision summary.

The Full-Fi…

AI-powered scope developer says new FDA clearance opens the door for telehematology

The Scopio X100 (left) and new X100HT [Image courtesy of Scopio Labs]Scopio Labs today announced FDA 510(k) clearance for its X100HT, which features a new slide loader that automatically prepares samples and feeds them into the digital blood scanner for AI-powered analysis.

The Tel Aviv-based digital microscope developer said the technology eliminates the need for manual microscopic examination when reviewing white and red blood cells and estimating platelet counts.

Based on the X100 that was 510(k)-cleared by the FDA in 2020, the X100HT has a slide loader with three cassettes that can each hold 10 slides. After the slides are placed in the cassettes and inserted into the slide loader, the slide loader automatically applies mounting media and a glass cover slip onto the slides and sequentially inserts them into the scanner for processing, according to the FDA’s decision summary.

Get the full story at our sister site, Medical Design & Outs…

FDA proposes pilot program for alternative medical device sterilization methods

The FDA is considering ways to make it easier for medical device manufacturers to switch sterilization methods.

The proposed master file pilot program, announced yesterday, would be for premarket approval holders whose approved devices are sterilized using radiation, including gamma radiation.

Said the FDA: “If implemented, this program would help medical device manufacturers advance alternative ways to sterilize their approved medical devices, including changing radiation sources, in a least burdensome regulatory approach.”

The agency said the pilot program would not be for 510(k)-cleared devices because such devices already do not require a new 510(k) submission for a change from gamma to another radiation source.

FDA officials think the program could help alleviate global supply chain constraints and support sterilization supply chain resiliency.

Overall, the FDA has been seeking to promote alternative medical device steriliz…

Medtronic issues another Class I recall for HVAD pump implants

Medtronic is recalling HVAD pumps for weld defects that could cause serious injury or death. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) is recalling 1,614 of its HeartWare Ventricular Assist Device (HVAD) pump implant kits due to defective welds connected to at least one death.

The Class I recall — the most serious type of FDA recall, in which use of the device may cause serious injuries or death — is the latest of more than 15 serious recalls for the Medtronic devices since 2014.

Fridley, Minnesota–based Medtronic halted sales and new device implantations in a Class I recall a year ago following complaints that the internal pump may fail or delay to restart.

Medtronic identified the new problem with pump weld defects this spring while investigating suspected cases of pump thrombosis in three patients, two of which died after their heart pumps were exchanged.

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