FDA Archives - Page 80 of 103 - Medical Design Sourcing

Pfizer asks FDA to authorize its COVID-19 vaccine for younger teens

Pfizer (NYSE:PFE) and its German partner BioNTech (NSDQ:BNTX) have asked FDA to extend the authorization of their COVID-19 vaccine to the ages of 12 to 15.

FDA authorized the vaccine for people 16 and older on Dec. 11, 2020.

The agency will likely extend its prior authorization to younger adolescents “if the data submitted support it,” according to Dr. Arnold Monto, acting chair of the Vaccines and Related Biological Products Advisory Committee meetings related to the Pfizer-BioNTech.

Pfizer plans to seek permission from other regulatory agencies to administer the vaccine to children 12 and over in the coming weeks.

The company currently has a Phase 3 trial underway involving 2,260 adolescents 12 to 15. The vaccine was 100% effective in that study, besting the results of a separate trial involving volunteers aged 16 to 25.

All 50 states plan to open up vaccine eligibility to those over 16 starting April 19.

Pfizer and BioNTech a…

Medtronic stent graft recall is serious

The FDA has deemed the recall of the Medtronic (NYSE:MDT) Valiant Navion thoracic stent graft system as Class I, the most serious kind.

Medtronic’s Valiant Navion is designed to repair lesions of the descending thoracic aorta, using a long catheter to place the stent graft inside the aorta before it expands to fit within the aorta to provide a new path for blood to flow from the heart to the lower part of the body, according to an FDA release.

Get the full story at our sister site, Medical Tubing & Extrusion.

FDA tells hospitals: Stop reusing disposable masks

The FDA issued guidance today recommending that healthcare personnel and facilities cease the reuse of disposable masks.

According to the recommendations, healthcare personnel and facilities should transition away from crisis capacity strategies like decontaminating or bioburden reducing disposable respirators for reuse.

The CDC’s National Institute for Occupational Safety & Health (NIOSH) approved an increased domestic supply of new respirators and made them available to facilitate the transition. Officials at FDA and CDC both believe there is an adequate supply of respirators, leaving no need to reuse them.

Decontaminated respirators and those which have undergone bioburden reduction should only be used when there are insufficient supplies of new filtering facepiece respirators (FFRs) or the user is unable to obtain any new respirators. FDA is encouraging healthcare personnel to transition away from decontaminating N95 masks and other FFRs an…

When can computer models replace animal trials?

Image courtesy of Pixabay

The pandemic has forced a rethink of clinical research, but the pharma industry continues to rely on animal testing. While pundits have observed that computer modeling and techniques such as microdosing can reduce animal testing, animal testing continues to be integral in preclinical studies.

But computer models are now sufficiently accurate to predict the response of many drugs, said David Harel, CEO of CytoReason (Tel Aviv, Israel). “We are getting to the point that computer models of certain diseases can generate better predictions than animal models,” he said.

But there are caveats. It could take longer to move from animal-based safety testing, which often involve rodents. Such animal trials tend to be limited in size. “They’re not a big burden. And they’re not super expensive,” Harel said. And regulators frequently consider animal data when evaluating drug safety. But …

FDA approves Bausch + Lomb dispersive ophthalmic viscosurgical device

Bausch + Lomb announced today that it received FDA approval for its ClearVisc dispersive ophthalmic viscosurgical device (OVD).

Laval, Quebec-based Bausch + Lomb, the eye health business unit of Bausch Health, developed the ClearVisc OVD for use in ophthalmic surgery to aid in cataract extraction and intraocular lens (IOL) implantation through the creation and maintenance of space, tissue manipulation, visualization enhancement and corneal endothelium protection, according to a news release.

ClearVisc contains the chemical agent Sorbitol, which is designed to deliver superior free radical protection when compared to other dispersive OVDs. The device helps to provide physical protection of the cornea from thermal and mechanical damage, as well as the chemical protection from damaging free radicals.

A multicenter, randomized clinical study of 372 subjects saw ClearVisc meet its primary safety and efficacy endpoints, while the device proved non-inferior to …

NuVasive wins FDA nod for disc replacement device

NuVasive (NSDQ:NUVA) announced today that it received FDA approval for its Simplify disc in two-level cervical total disc replacement (cTDR).

San Diego-based NuVasive’s Simplify cervical artificial disc, part of its NuVasive C360 portfolio, is comprised of PEEK on ceramic materials to allow for enhanced visualization through MRI postoperatively when compared to alternative devices, according to a news release.

Simplify is anatomically designed and includes 4mm, 5mm and 6mm options, while the proprietary design allows for a variable center of rotation for each treated level to closely mimic the motion dynamics of a natural spine segment.

The disc demonstrated clinical superiority at 24 months compared to anterior cervical discectomy and fusion (ACDF) in a two-level FDA investigational device exemption (IDE) study. The device also delivered an overall success rate that was nearly 10% higher when compared to ACDF.

“This approval is an inc…

FDA authorizes antibody test that uses blood collected at home

(Image courtesy of Symbiotica)

The FDA has granted emergency use authorization for the first COVID-19 antibody test that allows patients to collect blood at home.

The Symbiotica COVID-19 self-collected antibody test system enables adults to obtain a fingerstick dried blood sample at home from themselves or from a child age 5 or older and send it to a Symbiotica laboratory for analysis, according to the agency. The test is intended to aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating a prior infection.

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

FDA clears Philips’ Smart CT application software

[Image from Philips]Royal Philips (NYSE:PHG) announced today that it received FDA 510(k) clearance for its Philips SmartCT application software.

Amsterdam-based Philips’ SmartCT software is a component of the company’s Azurion image-guided therapy system for diagnosis, therapy planning, treatment and follow-up for interventional radiology procedures.

SmartCT helps to enhance clinical confidence, smooth the workflow and increase productivity through software applications for angiography, neurology, soft-tissue imaging and guidewire/catheter navigation for procedures that treat aneurysms, vascular disease and liver tumors, among others, according to a news release.

The platform enables control of the Azurion system on a touchscreen tablet situated alongside the interventional radiology table, eliminating the need for clinicians to leave the sterile field and step into an adjacent control room while also supporting faster and better-informed decisi…

Medtronic can’t shake suit over FDA clearance of spinal devices

(Image courtesy of Medtronic)

A federal appeals court has ruled that Medtronic must face a whistleblower lawsuit over FDA clearance of certain spinal fusion devices.

The Dan Abrams Company sued Medtronic in 2015 claiming that Medtronic defrauded the FDA into granting 510(k) clearance to certain Verte-Stack cervical vertebral body replacement (VBR) devices used in spinal fusion surgeries. The lawsuit also claims that Medtronic unlawfully marketed the devices for an off-label and contraindicated use, and illegally compensated physicians to use them.

Abrams also argues that these allegedly fraudulent practices caused physicians to submit false claims to Medicare. Dan Abrams Company is an LLC whose sole employee, Bryan Shapiro, formerly worked for Medtronic. His “fraud-on-the-FDA” claim states that since Medicare reimbursement requires FDA clearance, the subject devices would have been ineligible for reimbursement but for Medtronic’s alleged fraud.

…

MTF Biologics says FDA used old data to malign its surgical mesh

A surgical mesh company claims the FDA improperly called one of its products’ safety into question.

The agency said last week that two surgical mesh brands used off-label in breast reconstruction surgery have had “significantly higher major complication rates.”

It named FlexHD by MTF Biologics and AlloMax by BD as having had higher rates of explantation, reoperations and infections two years after surgery when compared with patients who received one of two other brands of surgical mesh or no mesh. The mesh type in question is an acellular dermal matrix (ADM) made of human or animal skin from which the cells are removed and the support structure is left in place.

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

Feds put J&J in charge of vaccine production at Emergent plant

Johnson & Johnson (NYSE:JNJ) announced that it assumed full responsibility for the production of its COVID-19 vaccine at the Emergent BioSolutions Bayview (Baltimore) facility.

The company’s announcement comes days after news broke that a factory error made at that facility resulted in 15 million discarded COVID-19 vaccines.

Get the full story at our sister site, Pharmaceutical Processing World.

Feds put J&J in charge of vaccine production at Emergent plant

Johnson & Johnson (NYSE:JNJ) announced that it assumed full responsibility for the production of its COVID-19 vaccine at the Emergent BioSolutions Bayview (Baltimore) facility.

The company’s announcement comes days after news broke that a factory error made at that facility resulted in 15 million discarded COVID-19 vaccines.

New Brunswick, N.J.-based J&J’s single-dose vaccine was authorized by the FDA for emergency use in March. Only a handful of days later, the Biden administration announced a contract for 100 million doses of the vaccine.

However, news came to light that, several weeks ago, workers at an Emergent BioSolutions (NYSE:EBS) facility in Baltimore made a mistake several weeks ago when formulating the ingredients for Johnson & Johnson’s COVID-19 vaccine, requiring 15 million doses of it to be discarded.

A quality control process revealed that one batch of a drug substance for the J&J COVID-19 vaccine “did n…