FDA Archives - Page 76 of 103 - Medical Design Sourcing

Cerapedics’ bone graft gains FDA breakthrough nod

Ortho-biologics company Cerapedics announced that it has won FDA breakthrough device designation for its investigational P-15L bone graft to treat degenerative disc disease (DDD).

The company plans to enroll at least 270 DDD patients in the Aspire study, a prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study to evaluate the safety and efficacy of P-15L bone graft compared to the use of an autologous bone graft when applied in spinal fusion surgery. Westminster, Colo.-based Cerapedics plans to file a premarket approval submission with the FDA with the results from this study, which will be conducted across 36 sites in the U.S.

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FDA revokes Battelle mask decontamination EUA

The FDA has revoked its authorization for Battelle Memorial Institute to decontaminate used N95 respirators for healthcare workers.

In a letter dated April 30, 2021, the agency said it revoked the EUA at Battelle’s request. The Columbus, Ohio-based research organization asked to withdraw the EUA for its Critical Care Decontamination System (CCDS) in an April 2 letter. Battelle said it is no longer operating or marketing the vaporized hydrogen peroxide systems, according to the revocation letter.

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BD’s Alaris pump hit with another recall

(Image courtesy of BD)

A medical supply company is recalling BD (NYSE:BDX) Alaris infusion pumps — the third such recall for the pumps in the past few months, according to the FDA.

North Carolina-based Avante Health Solutions issued the Alaris pump recall March 24, 2021, because the bezel repair posts may crack or separate, leading to the inaccurate delivery of fluids to patients. The separation of one or more bezel repair posts could result in the free flow of fluids to patients, over- or under-delivery of fluids, interruption of fluid delivery, device leaks, device component burning or smoking and/or power supply failure or malfunction.

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Pfizer and BioNTech seek EMA nod for younger adolescents

Image courtesy of Wikipedia

After announcing that its vaccine was 100% efficacious in a Phase 3 trial involving adolescents aged 12 to 15, Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) are seeking E.U. authorization to distribute the vaccine to that age group.

BioNTech’s CEO, Uğur Şahin, estimated that the vaccine would be available to early adolescents in 27 European countries starting in June.

The companies requested in early April that FDA lower the vaccine eligibility from 16 to 12 years of age.

Janet Woodcock, FDA’s acting commissioner, vowed to review the request “as expeditiously as possible using our thorough and science-based approach” but declined to estimate how long it would take to do so.

BioNTech and its partner Pfizer are currently overseeing vaccine clinical trials for children as young as six months old.

The companies also plan on asking other international regu…

AtriCure AFib treatment device wins FDA approval

AtriCure (NSDQ:ATRC) announced today that the FDA approved its EPi-Sense system for treating long-standing persistent Afib.

Mason, Ohio-based AtriCure’s EPi-Sense system demonstrated superiority in the Hybrid AF therapy arm compared to endocardial catheter ablation alone in the Converge clinical trial, according to a news release.

AtriCure’s Hybrid AF therapy is a minimally invasive procedure designed to provide a long-lasting solution for long-standing persistent Afib patients.

In patients diagnosed with long-standing persistent Afib, the Hybrid AF therapy arm presented a 29% absolute difference in efficacy at 12 months (78% relative improvement) and an absolute difference of 35% at 18 months (110% relative improvement).

Afib burden was reduced by 33% in the Hybrid AF group at 12 months and increased to 37% at 18 months, with the Converge trial proving that the Hybrid AF therapy offers durable, sustained efficacy, AtriCure said.

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FDA hits Acceleron Pharma with notice of noncompliance

FDA has sent its first notice of noncompliance to Acceleron Pharma, accusing the company of failing to submit summary results information to ClinicalTrials.gov for a Phase 2 trial.

The agency sent the company a letter warning of potential noncompliance in July 2020.

The National Library of Medicine, a part of the National Institutes of Health, operates the ClinicalTrials.gov database.

The clinical trial in question is an unsuccessful randomized, double-blind study comparing the combination of Dalantercept (ACE-041) and Axitinib (AG013736) to placebo and Axitinib in patients with advanced renal cell carcinoma.

The recent notice gives Acceleron 30 days to provide the summary results information FDA requires.

Companies typically have one year after trial completion to post results to the ClinicalTrials.gov site.

FDA has threatened the company with fines if it fails to release results from the trial. Parties can, however, request a delay…

Medtronic wins FDA breakthrough nod for Emprint ablation catheter kit

Medtronic (NYSE:MDT) announced today that it received FDA breakthrough device designation for its Emprint ablation catheter kit.

Fridley, Minn.-based Medtronic’s catheter is designed to be used in conjunction with the Emprint microwave generator and the Medtronic lung navigation platform to offer a minimally invasive, localized treatment of malignant lesions in the lung, according to a news release. It can also be used together with the standard of care therapy when indicated.

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FDA grants breakthrough nod for Fractyl’s type 2 diabetes treatment

Fractyl Laboratories announced today that it received FDA breakthrough device designation for its Revita DMR type 2 diabetes treatment.

Lexington, Mass.-based Fractyl’s Revita DMR treatment is an outpatient endoscopic procedure designed to resurface the upper intestine lining (duodenal mucosa) in metabolic disease for patients with insulin-treated type 2 diabetes. Preliminary clinical findings suggest that the treatment could decrease insulin resistance, improve glucose control, lower weight and reduce liver fat.

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BD asks FDA for new clearance to update software

(Image courtesy of BD)

BD (NYSE:BDX) said today that it has applied to the FDA for a new clearance for its recall-plagued Alaris infusion pump system.

BD has had shipments of Alaris pumps on hold after the FDA called for a comprehensive 510(k) submission to cover a host of software fixes needed following a Class I-level recall in March 2020. Pumps are only going to health providers with an immediate medical need.

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Feds to healthcare: Limit reusing masks

(Image courtesy of Brian McGowan on Unsplash)

The FDA recently told healthcare facilities they can start to limit the decontamination and reuse of disposable masks.

An increase in the domestic supply of new masks approved by NIOSH has made the practice less necessary, the agency said.

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FDA, CDC lift pause on J&J COVID-19 vaccine

The FDA and CDC have lifted the pause placed on the Johnson & Johnson (NYSE:JNJ) COVID-19 vaccine after reports of blood clots caused concern.

On April 13, the FDA and CDC issued a joint statement recommending the pause in the administration of the J&J (Janssen) COVID-19 vaccine after, among 6.8 million doses delivered in the U.S., six recipients experienced cases of a rare and severe type of blood clot. Of those blood clot cases, one death was recorded.

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FDA, CDC lift pause on J&J COVID-19 vaccine

This 2020 image shows a vial of J&J vaccine when it was investigational. Image from Johnson & Johnson.

The FDA and CDC have lifted the pause placed on the Johnson & Johnson (NYSE:JNJ) COVID-19 vaccine after reports of blood clots caused concern.

On April 13, the FDA and CDC issued a joint statement recommending the pause in the administration of the J&J (Janssen) COVID-19 vaccine after, among 6.8 million doses delivered in the U.S., six recipients experienced cases of a rare and severe type of blood clot. Of those blood clot cases, one death was recorded.

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