As radiopharmaceutical therapies gain momentum, new challenges are emerging in how they’re administered—especially around safety, precision, and workflow. Many targeted treatments, including Lutetium-177 and Actinium-225 therapies, require controlled infusions lasting up to 30 minutes. That’s a sharp departure from older radiopharmaceuticals, often delivered via quick 'bolus' injections by a Technologist’s hands. Yet most traditional healthcare infusion pumps weren’t built to support radiation shielding, dose customization, or regulatory compliance.
Nucleus RadioPharma, a radiopharmaceutical CDMO and solutions provider, is addressing the gap head-on. The company is developing a first-of-its-kind infusion system designed specifically for these modern demands. The device—currently in alpha development—is targeting a commercial launch in 2026.
Closing the Infusion Gap
Radiotherapy innovation has accelerated in recent years, but device technology has not kept pace. Many clinics still rely on volumetric or syringe infusion systems, despite critical differences in how radiopharmaceuticals must be handled. Without dedicated tools, healthcare providers face unnecessary risks—from inadequate radiation shielding to limited dosing flexibility and compliance with new regulations such as USP<825>.
Recognizing these barriers, Nucleus RadioPharma set out to rethink radiopharmaceutical delivery from the ground up.
“Radiopharmaceuticals are evolving, but the tools to deliver them have not,” says Dom Siewko, VP of Environmental Health & Safety at Nucleus RadioPharma. “We saw a clear opportunity to design an infusion solution from the ground up—something safe, smart, and purpose-built for nuclear medicine. This device is about protecting people, improving precision, and making radiotherapy more accessible for everyone involved.”
A Device Designed for Radiopharma
Nucleus’s new infusion system is being developed specifically for the complexities of theranostic radiopharmaceutical therapy infusion. At its core is a shielded, single-use, disposable fluid cartridge that connects directly to any standard hospital IV pump—no new hardware or tools required. The cartridge’s passive design allows the pump to control flow and volume, enabling precise, slow infusions while minimizing radiation exposure for staff and patients with great precision.
The system supports custom dosing, is compatible with alpha, beta, and gamma radiation types, and accommodates vial volumes up to 30 mL. Every feature is designed to meet the realities of clinical workflows and the demands of regulatory compliance:
● First infusion solution built specifically for radiopharmaceuticals and compatible with any hospital infusion pump
● Single-use, disposable fluid cartridge for any radiation type
● Cartridge fits inside a standard dose calibrator well for post-infusion residual assay
● Sterile Class II FDA-approved medical device (pending)
● Provides shielding in line with ALARA principles for both user and patient
● Compatible with standard IV tubing and saline sources
● Mountable on standard IV poles
● Supports personalized dosing and partial vial withdrawal
● Rinse/flush functionality to reduce drug waste and maximize dose accuracy
● Shielded system disinfects easily using standard hospital cleaners
● Passive cartridge design—existing IV pump controls volume and speed
● Snap-on connection requires no special tools and reduces vial puncture risks
Developed with input from Nuclear Medicine Technologists and Oncology Nurses, the system is designed to integrate into clinical workflows—improving safety, accuracy, and efficiency at every step.
Built for Compliance, Accuracy, and Scale
The regulatory landscape around radiopharmaceutical administration continues to evolve, with standards like USP<825> adding cost and complexity to Nuclear Medicine Departments. For many hospitals, the lack of newly required enhanced aseptic requirements and equipment makes traditional syringe-based administration a compliance risk—and a logistical burden.
Nucleus’s infusion system offers a safer, simpler solution. By enabling direct-from-vial infusion with precise volume control, a built-in rinse mechanism, and compatibility with dose calibrator wells, the device streamlines infusion activity data—critical for regulatory compliance and payer reimbursement.
It also brings measurable efficiency gains. With faster setup, fewer connections, and no specialized tools, clinicians can reduce treatment times and increase patient throughput. In a space where adoption is growing and clinical resources are stretched thin, that operational edge matters.
More Than a CDMO
Nucleus RadioPharma may be known as a CDMO, but its ambitions go far beyond manufacturing. With control over both vial format and supply chain infrastructure, the company is expanding its role—developing technologies that remove barriers to clinical success.
“This device is part of a bigger strategy,” says Dom Siewko, VP of Environmental Health & Safety. “By engineering around the vial, workflow, and regulatory challenges, we’re helping partners move from molecule to treatment with greater confidence and efficiency.”
The alpha version of the infusion system is currently in development. Regulatory submission is expected in the Fall of 2025 with a commercial launch anticipated the following year.
As radiopharmaceuticals move toward wider clinical adoption, scalable, patient-centered delivery systems are no longer optional—they're essential. Nucleus is stepping forward to bridge the gap between “big pharma” and the clinicians who treat patients by providing theranostic radiopharmaceuticals at scale with technology that makes treatment more accessible.
The editorial staff had no role in this post's creation.