MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Home » Cancer treatment: FDA panel says benefits of Novocure’s brain tumor device outweigh the risk

Cancer treatment: FDA panel says benefits of Novocure’s brain tumor device outweigh the risk

By

glioblastoma

A new treatment for a deadly form of brain cancer has received a favorable vote from an FDA panel, moving the device a step closer to the market.

The FDA’s neurological devices panel voted 7-to-3 with 2 abstains that there is reasonable assurance that the benefits of the NovoTTF-100A System (NovoTTF) made by NovoCure, outweigh its risks when, “administered as a monotherapy in place of standard medical therapy,” according to a prepared release from the company.

Read all of our coverage on NeoCure’s revolutionary treatment for brain tumors

The NovoTFF is a “non-invasive device, consisting of four sets of insulated electrodes attached to an electronic box,” according to the privately-held Israeli company.

A favorable vote from an FDA panel typically results in the granting of premarket approval or a PMA to allow the device to be sold in the United States. However, the agency can still rule against the device.

The Food and Drug Administration is considering the device as a treatment for glioblastoma “after surgical and radiation options have been exhausted.” Glioblastoma is the most common form of brain tumor and has a low survival rate.

“We are pleased with the outcome of the Advisory Committee’s vote on the safety and effectiveness of NovoTTF,” said Eilon Kirson, Novocure’s chief medical officer.

On March 16 an FDA reviewers document posted on the agency’s web site said that clinical trials of the devices failed to show a significant increase in the overall survivability rate when measured against chemotherapy, but did significantly improve quality of life when compared to aggressive forms of chemotherapy.

In case you missed it

RSS From Medical Design & Outsourcing

  • MIT engineers fabricate chip-free, wireless e-skin
    MIT engineers have developed a new wireless, wearable sensor without semiconductors or batteries in what they say is a first step toward chip-free wireless sensors. This electronic skin — or e-skin — is a flexible, semiconducting film that MIT describes as a sort of electronic Scotch tape. The device has an ultrathin gallium nitride film… […]
  • Owens & Minor and Allina Health partner on supply chain resiliency
    Owens & Minor (NYSE: OMI) and Minneapolis-based Allina Health are partnering on what they call a “unique integrated service model for supply chain resiliency.” An Owens & Minor distribution center that has been in operation for more than 25 years in Moundsview, Minnesota will serve as the integrated service center powering the model, the companies… […]
  • Chronic pain researchers say sound and electrical stimulation has treatment potential
    University of Minnesota researchers are using sound and electrical stimulation to treat chronic pain and other sensory disorders without pharmaceutical drugs. The combination of sound and stimulation activates the brain’s somatosensory cortex, according to a study on guinea pigs published in the Journal of Neural Engineering. Also known as the tactile cortex, the somatosensory cortex is… […]
  • What Laura Mauri learned from a ‘firestorm’ in her first months at Medtronic
    Dr. Laura Mauri faced a monumental moment with former Medtronic CEO Omar Ishrak shortly after she joined the company as VP of global clinical research and analytics. It was late 2018, and Mauri — who’s now an SVP and the chief scientific, medical and regulatory officer at Medtronic (NYSE: MDT) — was in a meeting… […]
  • Senators seek post-market FDA study of pulse oximeters and skin color
    Democratic U.S. senators are prodding the FDA to launch a post-market study of pulse oximeters due to unreliable performance for patients with dark skin. Pulse oximeters estimate blood oxygen levels (SpO2) and pulse rates in patients using infrared light — usually on a fingertip — at home or in clinical settings. Blood oxygenation is one… […]
  • TE Connectivity opens global medical device prototyping center in Ireland
    TE Connectivity (NYSE:TEL) today announced it opened its global Propelus Prototype Center for medical devices in Galway, Ireland. The $5 million rapid prototyping center was built into its existing manufacturing site in Galway and directly connects TE engineers with customers to reduce development time and increase speed to market for lifesaving and life-improving medical devices. Propelus… […]
  • Contract manufacturer Minnetronix Medical launches its first in-house product, MindsEye
    Minnetronix Medical has launched MindsEye, making it the first medical device that the contract developer and manufacturer has conceived and commercialized. St. Paul-based Minnetronix Medical’s MindsEye is the first expandable brain access port on the market. The FDA cleared the device under the 510(k) pathway in August 2020. The minimally invasive device gives neurosurgeons deep… […]
  • What’s next for Jennifer Fried after leaving Explorer Surgical?
    Explorer Surgical co-founder Jennifer Fried has resigned from the company after selling it to Global Healthcare Exchange in October. Fried announced her departure last week on LinkedIn, saying she’s preparing for her next professional chapter. “It’s bittersweet — I’m so proud of everything our team has built and accomplished,” Fried wrote. “The time has flown… […]
  • The 24 best medical device innovations of 2022
    The Galien Foundation recently announced its nominees of medical device innovations for its 2022 Prix Galien USA awards. There are 24 medical technologies nominated for the annual award this year, up from 18 nominees in 2021. The Galien Foundation’s annual Prix Galien awards highlight devices, biotechnology and pharmaceutical products designed to improve the human condition.… […]
  • FDA issues new COVID-19 testing guidance to avoid false negatives
    COVID-19 testing should be repeated following a negative result on any antigen test, the FDA said in a move that could increase demand for diagnostics manufacturers. The latest guidance from the federal health agency is for negative COVID-19 antigen test results regardless of the presence or absence of symptoms. The federal agency said recent studies… […]
  • Confluent Medical expands Costa Rica manufacturing footprint for nitinol, complex catheter production
    Confluent Medical Technologies this week announced the opening of its new addition to its Costa Rica manufacturing facility. The expansion adds 66,000 sq. ft to its large-scale manufacturing center of excellence in Alajuela, Costa Rica to expand Confluent’s capacity for nitinol component processing and complex catheter manufacturing. “Confluent has experienced consistent and strong growth in… […]

Leave a Reply