MassDevice

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

Home » Check-Cap, GE Healthcare close manufacturing line transfer

Check-Cap, GE Healthcare close manufacturing line transfer

By

Check-Cap, GE HealthcareCheck-Cap (NSDQ:CHEK) said it finalized a manufacturing line transfer implementation and qualification with the healthcare business at General Electric (NYSE:GE) for its C-Scan system, a preparation-free ingestible scanning capsule-based system designed to prevent colorectal cancer.

The C-Scan system is in the midst of a pilot clinical trial at the New York University School of Medicine and Mayo Clinic. Israel-based Check-Cap intends to continue the collection of clinical data ahead of a planned pivotal study. The system has received CE marking in Europe and approval from the Israeli Ministry of Health, the Medical Device Division. If positive results are obtained from the pilot trial, Check-Cap plans to file for FDA approval of a pivotal trial, to begin in 2020.

Check-Cap and GE Healthcare collaborated on C-Scan manufacturing for the U.S. clinical trials. Upon the successful completion of the current trial phase, the two companies plan to explore collaboration expansion opportunities.

“Our collaboration with GE Healthcare, a global leader in medical technology manufacturing, has established a solid manufacturing infrastructure for the C-Scan system,” Check-Cap CEO Alex Ovadia said in prepared remarks. “We are confident in GE’s ability to scale up production and intend to explore other possible collaboration opportunities, primarily in the U.S., while adhering to regulatory and safety standards in various markets worldwide, as we advance our pilot clinical trial in the U.S.”

“We have worked closely with the experienced Check-Cap team to transfer and qualify the manufacturing process of the C-Scan system to GE Healthcare,”added GE Healthcare general manager of Americas Pharmaceutical Diagnostics Marco Campione. “This partnership reflects our commitment to helping Check-Cap increase capacity, improve productivity and potentially leverage our global infrastructure to improve people’s lives.”

In case you missed it

RSS From Medical Design & Outsourcing

  • Junkosha boosts production of PTFE liners and FEP-based heat shrink
    Junkosha announced today that it plans to double production capacity to meet shortages of PTFE liners and FEP-based heat shrink for catheter manufacturers. Both OEMs and contract manufacturers in the catheter space are stressed from shortages in the global supply of vital components, according to the Japanese maker of sophisticated fluoropolymer application technologies. “We believe this… […]
  • Ahead of G7 launch, Dexcom CEO plans for ‘more activity than we’ve ever seen’ in 2022
    With a major product approval and launch in its sights, Dexcom prepares for a big year in 2022. Across 2021, Dexcom (NSDQ:DXCM) took several steps forward. The company touted its next-generation G7 continuous glucose monitor (CGM) and announced a major regulatory nod and partnership for real-time application programming interfaces (APIs), to list a couple. As the new year gets underway, expectations for the… […]
  • Former Zimmer Biomet executive has a new job
    Carrie Nichol, the former chief accounting officer of Zimmer Biomet (NYSE:ZBH), has a new job outside of the medtech industry. Nichol, who also served as vice president, controller and principal accounting officer at Zimmer Biomet, is now a VP and controller at Minnetonka, Minnesota-based Cargill. Her departure was among the many notable medtech executive moves… […]
  • Employees say Intuitive, Boston Scientific, J&J, Medtronic are among the best places to work in 2022
    Intuitive Surgical, Boston Scientific, Johnson & Johnson and Medtronic were recently named by Glassdoor as Best Places to Work in 2022 based on employee reviews. Each year, Glassdoor uses feedback that employees have shared on the website over the past 12 months to compile a list of the best places to work for the upcoming… […]
  • Medtronic’s M&A strategy explained by CFO Karen Parkhill
    When Medtronic CFO and EVP Karen Parkhill looks back at the medical device manufacturer’s performance through the COVID-19 pandemic, she recalls a key decision that rankled investors but paid off in the long run. “When I first joined Medtronic, it was shortly after the Covidien merger and we had taken on a lot of debt… […]
  • Loftware acquires Prisym ID
    Loftware announced that it acquired Prisym ID, a provider of regulated content and label management solutions. Prisym ID focuses on clinical trials, medical device and pharmaceutical labeling, with the acquisition set to expand Loftware’s enterprise labeling solution offerings for the medical device and pharmaceutical industries while enhancing Loftware’s end-to-end, cloud-based labeling platform with advanced clinical… […]
  • BD, Pfizer, Wellcome want to improve hospitals’ antimicrobial practices
    BD (NYSE:BDX) announced yesterday that it will collaborate with Pfizer (NYSE:PFE) and Wellcome to advance antimicrobial stewardship practices. The collaboration builds on ongoing efforts to advance the role of diagnostics in addressing the challenge of antimicrobial resistance (AMR), according to a news release. The companies will survey existing diagnostic practices to highlight benefits and gaps… […]
  • iRhythm CEO considers costs on the path to profitability
    Fresh off positive reimbursement news for its Zio remote external electrocardiogram monitoring device, the CEO of iRhythm Technologies (NSDQ:IRTC) doesn’t just have revenue on his mind. iRhythm President and CEO Quentin Blackford — the former Dexcom COO who replaced Mike Coyle in September — said his company will need to keep costs under control as it… […]
  • Integer Holdings makes additions to its executive team
    Integer Holdings today announced that it has appointed three new executives to its leadership team. The appointments come as part of a planned transition due to retirements. Margaret Cathy is being promoted to senior VP of quality and regulatory affairs; Andrew Senn is being promoted to senior VP of strategy and business development and McAlister… […]
  • Healthcare venture funding boomed in 2021; expect a slowdown in 2022
    An all-time-high $86 billion of venture capital investments in the U.S. and Europe last year bested 2020’s record haul by more than 30% and grew more than 150% from 2019, according to a new analysis by Silicon Valley Bank. After record-setting quarters in the first half, however, VC investment slowed due to poor performing biopharma… […]
  • Medical technical writers vs. medical writers: What’s the difference?
    By CfPIE Pharmaceutical organizations often have trouble conveying complex medical concepts to “layman” users like patients and the public. Being able to communicate medical device usage instructions, clinical trial results, patient education materials, and other important materials is essential for end-users to get the most out of your products and services while preventing potential health… […]