New York, NY, United States, 26th Aug 2025 - OceansBio Ltd., a leading innovator in biomedical technology, today announced its entry into the emerging era of “Device Similar” for implantable electroceuticals. With a focus on neurological disorders such as Parkinson’s disease, epilepsy, depression, and chronic pain, OceansBio is positioning itself at the forefront of this transformative shift in medical device innovation.
OceansBio Ltd.’s Vision for Device Similars
Building on the established concept of biosimilars in the pharmaceutical industry, Device Similars are designed to replicate the function, quality, and safety of original implantable devices once patents expire, at a fraction of the cost. OceansBio Ltd. is developing advanced solutions to ensure greater accessibility for patients requiring neurostimulation therapies.
“Just as biosimilars revolutionized the accessibility of biologic treatments, Device Similars hold the potential to make life-changing electroceutical therapies more affordable worldwide,” said Hyunung Lee, spokesperson for OceansBio Ltd.
Understanding Device Similars
While biosimilars reproduce complex biological medicines, Device Similars must duplicate sophisticated electronic medical devices with precision. This includes electronics, mechanics, embedded software, and biocompatibility, all subject to rigorous safety and quality standards for long-term use in the human body.
Unlike biosimilars, regulatory approval pathways for Device Similars can leverage mechanisms such as the FDA’s 510(k) clearance, provided substantial equivalence to an existing approved device is demonstrated.
Opportunities and Challenges
The introduction of Device Similars represents a significant opportunity to expand access to vital neurological treatments by lowering costs. However, developing these technologies requires addressing challenges such as ensuring electronic precision, overcoming patent barriers, and maintaining strict quality assurance to meet global regulatory requirements.
Future Directions for Korea and Global Expansion
OceansBio Ltd. believes Korean companies and regulators play a vital role in shaping the future of Device Similars. By investing in technological advancement and providing streamlined regulatory pathways, Korea can strengthen its global competitiveness in this rapidly evolving field. OceansBio is committed to leading by example through innovation, compliance, and collaboration.
The era of Device Similars in implantable electroceuticals is now underway, and OceansBio Ltd. is taking bold steps to lead this new chapter. With ongoing investments in research, development, and global partnerships, the company is dedicated to making advanced treatments more affordable and accessible for patients worldwide.
Media Contact
Organization: OceansBio Ltd.
Contact Person: Hyunung Lee
Website: https://oceansbio.com/
Email: Send Email
City: New York
State: NY
Country:United States
Release id:32852
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