FDA Archives - Page 82 of 103 - Medical Design Sourcing

FDA approves Medtronic’s Harmony transcatheter pulmonary valve system

FDA has approved a Medtronic device described as a first-in-the-world, non-surgical heart valve to treat severe pulmonary valve regurgitation — a condition often arising from congenital heart disease.

The Harmony transcatheter pulmonary valve system could delay the time before someone with congenital heart disease might need additional open-heart surgery, FDA said today. The Harmony device could also potentially reduce the number of open-heart surgeries needed over a person’s lifetime.

“The Harmony TPV provides a new treatment option for adult and pediatric patients with certain types of congenital heart disease,” said Dr. Bram Zuckerman, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health.

“It offers a less-invasive treatment alternative to open-heart surgery to patients with a leaky native or surgically-repaired RVOT and may help patients improve their quality of life and return to …

Medtronic recalls oxygenator used for cardiopulmonary bypass among kids

Image from Medtronic/FDA

The FDA has issued a Class I recall for the Medtronic Affinity Pixie oxygenator and cardiotomy/venous reservoir with Balance biosurface.

Medtronic’s Affinity Pixie system with Balance biosurface is designed for treating newborns, infants and small pediatric patients requiring cardiopulmonary bypass. The system adds oxygen to the blood and removes carbon dioxide, while the venous reservoir supports and improves blood circulation during cardiopulmonary bypass.

According to an FDA notice, Medtronic is recalling the Affinity Pixie with Balance biosurface due to potentially elevated levels of harmful bacteria called endotoxins. Using the device with high levels of endotoxins could result in fever, infection, acute systemic toxic reaction or death, although there have been no complaints or reports of injuries or deaths related to the issue.

The recall affects devices distributed between April 29, 2020, and Nov. 20, 2020. Medtroni…

Study: Remdesivir supports clinical improvement in hospitalized COVID-19 patients

Remdesivir diagram

A multicenter study involving a substantial number of minorities indicated that remdesivir supported clinical improvement in the majority of patients.

The hospitalized remdesivir group had an average time to clinical improvement of five days versus seven days for those not receiving the drug. Remdesivir recipients had a 28-day mortality rate of 7.7% compared with a 14% rate for matched controls. The study authors note, however, that this finding was not statistically significant in the time-to-death analysis

Combining remdesivir with corticosteroids did not appear to provide additional benefit.

The study, which was recently published in JAMA, involved 2,483 patients in a five-hospital system in Baltimore, and Washington, D.C.

From that patient pool, 342 participants received remdesivir, with 184 of those individuals also receiving corticosteroids. More than 80.0% of th…

GE Healthcare 2D/3D imaging system wins FDA nod

(Image courtesy of GE Healthcare)

GE Healthcare has announced FDA 510(k) clearance for a new surgical imaging system capable of 3D and 2D imaging.

OEC 3D offers interoperative 3D imaging with precise volumetric images for spine and orthopedic procedures, according to GE Healthcare. It combines the benefits and familiarity of 2D imaging with OEC C-arms, delivering a familiar user experience with the added benefit of quickly capturing a 3D scan, the company added.

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FDA clears Optellum AI-based software system for early lung cancer diagnosis

Optellum announced today that it received FDA 510(k) clearance for its Virtual Nodule Clinic for early lung cancer diagnosis.

Oxford, England-based Optellum’s product is an AI-powered clinical decision support software system for pulmonologists and radiologists managing patients with nodules (small lesions) in the lungs that could represent early-stage lung cancer, according to a news release.

The company touts its offering as the first such application of AI decision support for early lung cancer diagnosis that was cleared by the FDA.

Optellum’s Virtual Nodule Clinic allows pulmonologists to identify and track at-risk patients with suspicious lung nodules and to make optimal clinical management decisions.

The software includes a clinically validated lung cancer prediction (LCP) score designed to offer more accurate and consistent lung cancer risk evaluations. Optellum’s LCP score is powered by the Radiomics digital biomarker and…

Companies, docs alarmed by proposed 510(k) rollback

Medical associations and device companies have largely come out against a Trump administration proposal to permanently exempt certain medical devices and software from the FDA 510(k) clearance process.

HHS used Trump’s waning days in office to propose permanently exempting 83 Class II devices and one unclassified device from the clearance review process. The list includes home ventilators, cardiopulmonary bypass pressure gauges, fetal cardiac monitors, long-term extracorporeal support systems, certain imaging software, ethylene oxide sterilizers and aerators, and certain masks (including N95 respirators), gloves and gowns. The agency also listed seven types of patient examination gloves that it has decided to immediately stop reviewing for 510(k) clearance. The notice was published on Jan. 15, 2021, in the Federal Register.

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FDA sends Novo Nordisk refusal to file letter for weekly 2-mg semaglutide

Novo Nordisk announced that the FDA issued a refusal-to-file letter related to its application to expand the label for once-weekly subcutaneous Ozempic (semaglutide).

The company had sought to expand the label for a 2.0-mg dose of once-weekly semaglutide to treat type 2 diabetes. It filed the letter on Jan. 20, 2021.

The letter indicates that FDA has concluded additional information is needed to review an application.

FDA requested information related to the new proposed manufacturing site for the drug.

Novo Nordisk stated that it believes it has sufficient data to warrant the label expansion application.

The company plans to resubmit the application to FDA in the second quarter of 2021.

The current FDA labeling recommends patients begin taking 0.25 mg of semaglutide once weekly, increasing to 0.5 mg after four weeks. Patients who require additional glycemic control can have the dose to 1 mg once weekly after an additional four weeks…

Allergan must face breast implant class action

A federal judge in New Jersey on Friday shut down part of Allergan’s request to dismiss a multi-district lawsuit over its Biocell textured breast implants, but kept most other parts of the litigation.

Judge Brian Martinotti ruled that some of the plaintiffs’ claims against Allergan (now part of AbbVie) were preempted by federal law while most others could stand — including one alleging that Allergan failed to report adverse events related to Biocell implants to the FDA.

Textured breast implants have been linked to BIA-ALCL, a type of non-Hodgkin’s lymphoma. The FDA asked Allergan to recall its Biocell textured implants in July 2019, saying that “the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers.”

The recall covered 246,831 Biocell implants in the U.S., according to the judge’s order. Allergan refuses to pay the implants’ users for …

FDA authorizes first machine learning-based screening device for COVID-19 biomarkers

The FDA announced that it authorized the first machine learning-based screening device for identifying COVID-19 biomarkers.

Tiger Tech Solutions’ COVID Plus Monitor received emergency use authorization (EUA) as a non-diagnostic screening device for identifying certain biomarkers that are indicative of some types of conditions, including hypercoagulation (which causes blood to clot more easily than normal), according to an FDA release.

The monitor is intended for use by trained personnel to help prevent exposure to and the spread of SARS-CoV-2, the virus causing COVID-19. The biomarkers it identifies, including other hypercoagulable conditions (like sepsis or cancer) or hyper-inflammatory states, may be indicative of infection with the virus in asymptomatic individuals over the age of five.

Tiger Tech’s monitor is designed for use following a temperature reading that does not meet criteria for fever in settings where temperature check is being…

CMS delays breakthrough device Medicare coverage

Medicare coverage for FDA-designated breakthrough medical devices will have to wait, despite broad support.

The Centers for Medicare and Medicaid Services (CMS) issued a final rule in January granting coverage for breakthrough devices the same day as their FDA approvals. The rule was supposed to take effect March 12, but CMS has postponed the Medicare Coverage of Innovative Technology (MCIT) final rule by 60 days to give the public more opportunities to comment, the agency said in a Federal Register notice.

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FDA clears Life Spine Prolift Wedge expandable spacer system

Life Spine announced today that it received FDA clearance for its Prolift Wedge expandable spacer system.

The Prolift Wedge expandable interbody spacer system with Osseo-Loc surface technology is a lordotic expandable implant for use in micro-invasive transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) procedures, according to a news release.

Huntley, Ill.-based Life Spine’s device is designed to maintain coronal alignment while achieving sagittal correction through up to 15 degrees of controlled lordotic expansion. It includes multiple implant height and width options to optimally fit a patient’s disc anatomy, too.

Once a patient-specific correction has been made with the height and width, the wedge is auto-locked in position and can be packed with graft in situ through Life Spine’s Osteo-Line graft delivery device.

“The launch of Prolift Wedge furthers our commitment to offering patient ma…

Why Emulate launched a colon intestine chip

Colon chip from Emulate

Emulate has debuted what it terms a “colon intestine chip” targeted at pharma and biotech companies, academics and other researchers. The company believes the system will accelerate the identification of drug candidates to treat inflammatory damage in the colon.

The technology could be a boon for understanding inflammatory bowel disease, which approximately 1.6 million people in the U.S. About 70,000 cases of the disease are diagnosed annually, according to the Crohn’s & Colitis Foundation of America. Many of those cases don’t respond to therapy, according to Lorna Ewart, executive vice president of science.

Emulate’s new intestine model combines human colonic organoids and supportive colonic endothelial cells to create an environment that simulates peristalsis.

In the following interview, Ewart describes potential applications of the new colon platform, touche…