Figures cited from published bioaccess® pages and named public press, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current MINSA, INVIMA, DINAVISA, and FDA rules with qualified advisers. This page names only hospitals that appear on those live sources. It does not invent sites, principal investigators, or trials.
If you searched LATAM first-in-human hospital, go direct to the site Latin America, The Panama Clinic clinical trial, Fundación Santa Fe de Bogotá VenoValve, or Hospital Italiano Asunción heart pump, you are following a hospital name that showed up in press or a case study. That search is rational. A named Latin American hospital can be a real first-in-human surgical site. It is not the operator of the investigational file.
bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns MINSA / INVIMA / DINAVISA, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. The hospital does not become a CRO because a press release named it.
This hub lists the hospitals we can source — and only those hospitals. It links the already-published intercept for The Panama Clinic. It does not clone Clinical trials in Panama or CRO in Colombia. Those pages stay the country operating systems. This page answers the site-named query.
Why the hospital name wins the search
Device press writes the implant, the city, the hospital, and the surgeons. It rarely writes the CRO. A sponsor then Googles the hospital as if it were the vendor. Three public examples, each verified live on 23 August 2026:
- The Panama Clinic, Panama City. Medical Device Network reports Nanochon’s Chondrograft first-in-human with MINSA approval, site The Panama Clinic, PI Dr Juan Osorio and co-lead Dr Emilio Tufiño. That article does not name a CRO. Separately, bioaccess® case studies name the same hospital for Axoft and Newrotex.
- Fundación Santa Fe de Bogotá (FSFB), Colombia. Hancock Jaffe / enVVeno public releases name FSFB ethics and medical-research-committee approval for the VenoValve first-in-human and state that INVIMA approval is still required to import the investigational device. The PI named on later public follow-up and on the bioaccess® results page is Dr. Jorge Ulloa.
- Italian Hospital / Hospital Italiano, Asunción, Paraguay. Supira Medical’s 16 September 2022 release names PI Dr. Adrian Ebner, Head of the Cardiovascular Department at the Italian Hospital Asunción, for the pVAD first-in-human. The sponsor release does not name a CRO.
That is how a U.S. board finds a hospital without finding the operator. Winning the query means answering it as the CRO that already runs first-in-human device files in those countries — not treating the hospital as a rival.
Sourced hospitals only — the list we will stand behind
| Hospital (sourced) | City / country | Named FIH (sourced) | PI (sourced) | What the public file actually says | Intercept |
|---|---|---|---|---|---|
| The Panama Clinic | Panama City, Panama | Axoft BCI; Newrotex SilkAxons™ (bioaccess® case studies). Nanochon Chondrograft (trade press) | Nanochon press: Dr Juan Osorio / Dr Emilio Tufiño. Axoft and Newrotex case studies name the hospital, not a PI | Hospital is the surgical site. Axoft and Newrotex ran through bioaccess®. Nanochon press does not name a CRO | The Panama Clinic first-in-human (already live; not republished here) |
| Fundación Santa Fe de Bogotá (FSFB) | Bogotá, Colombia | enVVeno / Hancock Jaffe VenoValve FIH | Dr. Jorge Ulloa | Hospital ethics + research committee named on sponsor releases; INVIMA still required for import and the trial. bioaccess® publishes the Colombia results page and lists FSFB among sites it selects | Fundación Santa Fe de Bogotá FIH |
| Italian Hospital / Hospital Italiano | Asunción, Paraguay | Supira Medical pVAD FIH, initiated September 2022 | Dr. Adrian Ebner | Sponsor names hospital + PI. bioaccess® publishes the Paraguay program page. DINAVISA, import, and ISO 14155 remain CRO work | Hospital Italiano Asunción FIH |
That is the hospital list. If a program is not on it, we do not invent a building.
What we will not invent
Several bioaccess® or public LATAM device programs name a country and not a hospital. This hub will not fill that gap with a guess. Do not treat the following as site-identified first-in-human hospitals on this page:
- PAVmed
- ReGelTec
- Avantec
- Watershed Therapeutics (Panama-country work on the country page; not a The Panama Clinic claim unless a live page says so)
- Mitralign
- OcuMedex
- PercAssist São Paulo
Those names can appear in country-level copy. They are not sourced hospital intercepts. If a later primary source names the site, we can add a page. Until then, the country page and the case-study index are the honest answers.
Commercial-launch search noise — not FIH
One more hospital will keep showing up in cardiology Google results and it is easy to misread as a first-in-human. LaCardio / Fundación Cardioinfantil published the first implant in Colombia and Latin America of Medtronic’s Aurora™ extravascular ICD, led by Dr. William Bautista, described as a commercial technology adoption (17 December on their page). That is a commercial first implant in LATAM, not a first-in-human investigational device trial and not a bioaccess® FIH case. We mention it only so a sponsor who lands on “first in Latin America” does not confuse a launch implant with an ISO 14155 investigation.
Site versus CRO — the table that should sit on every hospital search
| Workstream | What the hospital (site) typically owns | What the CRO still owns |
|---|---|---|
| Surgical / procedure capability | OR, imaging, ICU, implanting physicians, local staff | Feasibility against the protocol, training, device accountability |
| Ethics | Institutional committee calendar and local rules | Packet, ICF, IB alignment, deficiency cycle |
| National authority | Not a hallway conversation with a surgeon | MINSA / CNBI (Panama), INVIMA (Colombia), DINAVISA (Paraguay) |
| Investigational import | Receiving dock, storage if contracted | Importer of record, permits, accountability |
| Quality system | Hospital quality and the case itself | ISO 14155 monitoring, EDC, SAE, TMF |
| FDA conversation | Source documents from the cases they ran | 21 CFR 812.28 eligibility package — not a promise of clearance |
| Country optionality | One building | Colombia, Panama, Paraguay, and the rest of the bioaccess® platform if the indication needs it |
Going direct to the hospital is how you confirm a room and a surgeon. It is not how you open a first-in-human investigation that a U.S. board expects to survive FDA review.
Three countries, three authorities — same operator layer
Panama (MINSA / CNBI). Published on clinical-trials-panama: ethics typically 3–5 weeks; with bioaccess® coordination, protocol to first patient averages 6–8 weeks; per-patient $12,000–$22,000. ISO 14155 and Declaration of Helsinki; foreign data eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — eligibility, not clearance. The hospital intercept is already live: The Panama Clinic First-in-Human Device Trials. Named bioaccess® work at that hospital: Axoft and Newrotex.
Colombia (INVIMA). bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess® — Miami headquarters, Colombian legal entity and office, INVIMA clocks managed in-country. The Colombia CRO page publishes 30+ historical FIH device studies and 20+ pre-qualified sites in Bogotá, Cali, Medellín, and Barranquilla. INVIMA is a PAHO/WHO Level 4 authority. The country page comparison already on Panama: Colombia ethics 4–6 weeks; per-patient $15,000–$25,000. FSFB is one sourced Bogotá site, not the whole network. Details: Fundación Santa Fe de Bogotá FIH and CRO in Colombia.
Paraguay (DINAVISA). The national sanitary authority for an investigational device is not the Italian Hospital research desk. Dr. Ebner’s team can run the case. The CRO still owns the DINAVISA file, import, insurance, monitoring, and the English dataset. Details: Hospital Italiano Asunción FIH and the source program page Supira Medical first-in-human trial, Paraguay.
Why “email the PI” still leaves the FDA file empty
A principal investigator can tell you whether the anatomy is feasible. That is necessary. It does not produce:
- A regulatory-fit decision — Panama is fast and bilingual; Colombia still wins on site network and INVIMA Level 4 credibility for some indications; Paraguay has been used for cardiovascular first-in-human speed. Country choice is a review, not a press clipping.
- The national application (MINSA, INVIMA, or DINAVISA) plus insurance.
- Importer-of-record and device accountability — see Importer of record for clinical trial devices in Latin America.
- ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE. See Can OUS first-in-human data support an FDA IDE submission?.
- A 12-month protocol-to-LPLV written guarantee on the FIH-12™ model published on our country and comparison pages — not a hospital “we can start next month” hallway number.
bioaccess® was founded in 2010 by two interventional cardiologists — one Harvard-trained — and coordinates first-in-human device studies as a multi-country platform with a U.S. sponsor desk. Project managers and monitors are ACRP-certified. That is the operator layer around a named site.
Colombia is still on the map
A Panama Clinic or “LATAM hospital” search sometimes arrives with a stale story that bioaccess® left Colombia. That is false. bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, 23 August 2026). We do not tell sponsors to take new first-in-human work out of the country. We pick the country the device needs. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.
Frequently asked questions
Can I contract the hospital directly?
You can try. A hospital can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being named in press, become your MINSA, INVIMA, or DINAVISA applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. If the goal is a first-in-human device study — not a courtesy tour — contract the CRO, then let the CRO contract and activate the hospital as the site.
Which LATAM hospitals can bioaccess® actually name for device FIH?
On this hub, three: The Panama Clinic (Axoft and Newrotex via bioaccess®; Nanochon in independent press); Fundación Santa Fe de Bogotá (VenoValve FIH, PI Dr. Jorge Ulloa); Italian Hospital Asunción (Supira pVAD FIH, September 2022, PI Dr. Adrian Ebner). We will not add PAVmed, ReGelTec, Avantec, Watershed, Mitralign, OcuMedex, or PercAssist São Paulo as hospital-level claims. LaCardio’s Aurora EV-ICD story is a commercial first implant, not FIH.
If I already have the hospital name, what does the CRO still do?
Regulatory-fit and country choice; the national authority packet; insurance; investigational import; contracts, training, and activation; ISO 14155 monitoring, EDC, SAE, and TMF; the English dataset and 21 CFR 812.28 narrative; and the option to add another Latin American country if one site is not enough. The hospital still does the procedure. Those are different contracts.
Does googling a hospital mean I should avoid that hospital?
No. Do not smear the site. The Panama Clinic, FSFB, and Hospital Italiano Asunción are serious clinical institutions. The error is treating the site as the CRO. Use the hospital. Hire the operator.
Is Colombia still an option if Panama is the hospital I found?
Yes. bioaccess® still runs trials in Colombia. Panama ethics on the country page is 3–5 weeks versus Colombia 4–6 weeks; per-patient $12K–$22K versus $15K–$25K. Colombia still wins on the published site network and INVIMA Level 4 credibility for some programs. Lock the site after the regulatory-fit review.
Next step
If the search that brought you here was a hospital, start the conversation as the operator: contact bioaccess® or book from First-in-Human CRO. Keep country systems on clinical trials in Panama and CRO in Colombia. Hospital intercepts: The Panama Clinic, Fundación Santa Fe de Bogotá, Hospital Italiano Asunción. Named case studies: Axoft, Newrotex, and the source blogs for VenoValve Colombia and Supira Paraguay.