Medical solutions
worldwide.
Medical devices you can rely on. For four decades Bio-Med USA has developed, cleared and distributed aesthetic, surgical, dental and diagnostic devices — and guided manufacturers through FDA 510(k) clearance to do the same.
Four categories, 10 platforms.
From fractional CO2 resurfacing to AI-assisted retinal screening — each platform is selected for clinical reliability first and specified for the practice that will run it.
Aesthetic & Dermatology
Fractional CO2, Q-switched Nd:YAG, intense pulsed light and narrowband LED platforms for resurfacing, pigment, vascular and hair-reduction indications.
Surgical & Vascular
Near-infrared diode laser platforms for precise soft-tissue and endovascular procedures.
Dental
CO2 laser systems built for oral soft-tissue surgery — faster cutting, less anaesthesia, quieter chairside experience.
Diagnostics & Screening
AI-assisted retinal screening and FDA-cleared rapid test kits for primary-care and community screening programmes.
I-VIEW100
AI-assisted fundus camera for first-line screening of three blinding diseases. Automated capture and an on-board AI algorithm return a red, yellow or green risk indication within one second — so retinal screening can run in a primary-care room rather than only in specialist ophthalmology.
FDA clearance is vital to your market success.
Our consultants have over 15 years of experience making sure a 510(k) submission is accurate and complete. Missing information and deficiencies can delay a product launch by months — we work with you from preparation through the FDA's 90-day review period and final device listing registration in FURLS.
Quality and innovative technology.
We believe in quality and innovative technology, in addition to providing productivity and reliability to all our customers.
Young Chi — Founder & Chief Executive Officer
Represent Bio-Med USA in your market.
We work with distributors and clinical partners across domestic and international markets. Tell us your territory and the categories you cover, and we will come back with the platforms that fit and the regulatory position in your region.