General information, not legal or regulatory advice. Confirm current ethics and national-file rules with qualified advisers. We do not invent clocks, rates, or named studies that are not on the locked public sources cited here. No patient data. No unpublished client. Always bioaccess®.
If you searched Avania Canada FIH device CRO, Avania Unity Health Toronto Remedy N1, Avania Health Canada first-in-human, you were looking for a first-in-human / early-feasibility medical-device CRO in Canada. Competitor watch on this cluster is the named AU/IL/CA FIH CRO set only: Avania, Novotech, GreenLight Clinical, Bioforum, JSS Medical Research. We do not invent extra CRO brands. We do not invent extra named sponsors. We do not sell insurance. We do not name a carrier as a signed partner. Nanochon stays HOLD. NextLife is not a new steal. Magical BTK stays off this page. No PHI.
The only named Avania-Canada device FIH we will put on a public page from the locked 1 Sep 2026 keeper is Remedy Robotics and the investigational Remedy N1 endovascular surgical robot. FIH at Unity Health Toronto: St. Michael’s Hospital (patients) and St. Joseph’s Health Centre (operator), led publicly by Vitor Mendes Pereira, MD. Company and press describe fully remote neurointerventional FIH (Oct 2025) and an earlier Nov 2024 fully robotic neurointerventional procedure in a human. Avania’s success-stories page is the CRO + Health Canada / FDA submissions partner (David Bell testimonial). Device still investigational / not for sale. We will not invent other named Canadian Avania sponsors onto this page.
This page is not a leftover-site hospital intercept and not an insurance intercept. Distinct slug. Distinct title. The job is country 2: keep Canada if it is already running, add Latin America for the next protocol, the expansion, or the backup geography. Eligibility of foreign data under 21 CFR 812.28 is not FDA clearance. See OUS FIH and FDA IDE.
What this search is actually buying
You searched Avania Canada because a hospital-robot or neurointerventional FIH is already sitting in Toronto. The steal is not ripping Unity Health out of a live protocol. The steal is the next geography, the pivotal n, or a Latin American satellite that does not wait on another Health Canada CTA cycle. bioaccess® does not claim the Remedy study. We do not email from this page. Existing jmclark outreach to that company is a separate HOLD — not a public CTA.
Locked facts only
Legal name Remedy Robotics, Inc. HQ described as San Francisco on the Oct 6, 2025 PR Newswire and company jobs copy. Device: Remedy N1, remotely operable endovascular surgical robot (neuro / cardiovascular). CRO: Avania, clinical trial with Unity Health; Health Canada + FDA submissions. We will not treat aggregator street addresses as verified HQ. We will not publish a mailbox on this page. We will not add Turing Medical, SoundBite, or anonymous Avania blurbs as if they were Canadian named FIHs.
What country 2 looks like for a remote endovascular robot
A second-country protocol still needs ethics, import, radiation/cath-lab credentialing where the device needs it, ISO 14155 monitoring, and an SAE clock. Unity Health is not a Latin American importer of record. A Health Canada authorization is not MINSA, ISP, ANVISA, or COFEPRIS. If the next n is in Panama, Chile, Brazil, Mexico, or El Salvador, that is a new stack. We will not invent a Canadian clock here. Use the live LATAM hubs cited below.
Country 2 is LATAM. It is not a second Australian CTN, and it is not a new Colombian FIH CTA
Canada-only NCT rows are the sibling intercept. This page is the Avania-Canada operator. Do not clone leftover-site hospital pages. Do not mix Magical BTK. Do not name HDI.
Use clinical-trials-panama. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national file. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Published ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks on that hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. A hallway conversation at this hospital is not MINSA clearance.
Use clinical-trials-chile. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration in a 30–90 day band is a different file — do not put trial authorization and commercial registro on one Gantt labeled “Chile.” An Ethical-Scientific Committee under Law 20.120 still has to sit. We will not invent PAHO/WHO Level 4 standing for ISP on this page.
Use clinical-trials-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.
Use clinical-trials-mexico and CRO in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. Keep trial clocks separate from registro sanitario (~30 working days on that hub). Eligibility of foreign data under 21 CFR 812.28 is not a guarantee of clearance.
El Salvador is a public bioaccess® geography (DNM on llms.txt; live hub at clinical-trials-el-salvador). We will not invent a new Salvadoran clock here.
Colombia stays market access
Public line, unchanged: INVIMA commercial medical-device registration remains a core bioaccess® service. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. Country 2 on this cluster is Panama, Chile, Brazil, Mexico, or El Salvador — not a new Colombian FIH CTA. The Panama country page still publishes ethics 3–5 weeks vs. Colombia 4–6 weeks and per-patient $12K–$22K vs. $15K–$25K. Always bioaccess®. The founder podcast is Global Trial Accelerators™.
Historic Colombia FIH on public bioaccess® pages is not a reason to book a new INVIMA FIH from this cluster. Do not treat a Bogotá hospital NCT row as country 2.
What bioaccess® still owns on the steal
- ISO 14155 field-clinical, not a Phase I unit brochure. Hospital implant and interventional sites in Panama, Chile, Brazil, Mexico, El Salvador as the device needs.
- Protocol, IB, ICF, ethics / national file in the same stack. A hallway conversation at an Australian private hospital is not that file.
- Importer of record and device accountability. See importer of record for clinical trial devices in Latin America. A CTN or Health Canada CTA does not import the investigational product into Latin America.
- 21 CFR 812.28 narrative if the next stop is an FDA IDE. Eligibility of foreign data is not a guarantee of clearance.
- No AU / IL / CA legal entity required to start country 2. Do not wait on R&DTI, a second CTN, or a Toronto MSA to generate the next n.
The firm was founded in 2010. Public device case studies already on llms.txt (ReGelTec, Axoft, Newrotex, enVVeno, Avantec Vascular / Sangria™ as published) show FIH execution. We will not invent a new named client onto this page.
Frequently asked questions
Is bioaccess® trying to replace the incumbent CRO on a live protocol?
No. If Avania, Novotech, GreenLight Clinical, Bioforum, or JSS is already running country 1, the steal is the next protocol, the expansion, or a LATAM satellite — not a mid-study rip-out we invent.
Do you sell clinical trial insurance on this page?
No. We are the FIH CRO. Insurance intercepts live on their own slugs. We do not underwrite. We do not name HDI as a partner here.
Is Colombia the country-2 default?
No. New FIH execution is not the Colombia CTA on this cluster. INVIMA registro remains. See the Colombia paragraph above.
Next step
If the search that brought you here was Avania Canada as the FIH device CRO, start as the operator: contact bioaccess® or book from First-in-Human CRO. Sibling: Avania Australia. Combined IL/CA NCT intercept: Israel- or Canada-only NCT → LATAM.
Julio G. Martinez-Clark, CEO · bioaccess®