The U.S. remains the world's largest healthtech market, but the visa landscape has fundamentally shifted for founders in 2026. With certain new H-1B petitions requiring consular processing now carrying a $100,000 Presidential Proclamation fee (effective September 21, 2025; currently under judicial review) and Canada's Startup Visa paused, healthtech entrepreneurs may benefit from a strategic approach to immigration. The good news? 55% of billion-dollar U.S. startups had at least one immigrant founder, according to a 2022 NFAP study, showing that the right visa strategy can unlock extraordinary outcomes. Alma's immigration legal services help healthtech founders identify potential pathways, whether that's the merit-based O-1A, the self-petition EB-2 NIW, or alternatives like the L-1A for international expansion.
The 2026 immigration environment presents both challenges and opportunities for healthtech entrepreneurs. Policy shifts have made some traditional pathways more expensive while elevating merit-based options that may favor innovators with proven track records.
The United States represents the largest healthcare market globally, with regulatory pathways like FDA approval serving as gold standards worldwide. For healthtech founders building AI diagnostics, telemedicine platforms, or medical devices, U.S. presence can often be important for access to the world's largest venture capital ecosystem for health innovation, FDA regulatory engagement and clinical trial opportunities, partnership potential with leading health systems and payers, and talent recruitment from top biomedical research institutions.
Healthtech entrepreneurs face unique obstacles in the immigration system. Timing mismatches between clinical trials, FDA submissions, and visa lottery schedules can create friction. Most visas require employer sponsorship, which limits founder flexibility. Some visa categories demand substantial personal investment. And proving "extraordinary ability" requires careful, strategic evidence compilation. The visa categories below address these challenges differently, and understanding each option's strengths can help founders match their profile to an appropriate pathway.
The O-1A visa is a premier option for healthtech founders who can demonstrate extraordinary ability in their field. Unlike lottery-based alternatives, the O-1A offers predictable, merit-based adjudication with rapid processing.
Qualifying evidence for healthtech may include patents on medical devices, diagnostic algorithms, or therapeutic innovations; peer-reviewed publications in health informatics, biotech, or clinical research; FDA submissions or regulatory achievements; significant venture capital funding (Series A or beyond); awards or competitive research grants; and judging roles at industry conferences or grant review panels.
The O-1A offers notable flexibility:
Self-sponsorship may be possible through a founder's own healthtech startup with proper corporate structure. Many founders use the O-1A as a bridge to the EB-1A green card, which shares similar evidentiary criteria and leads to permanent residency.
For healthtech founders seeking permanent residency without employer dependency, two self-petition green card categories offer compelling paths.
The EB-1A requires demonstrating that the applicant is among the small percentage who have risen to the very top of their field of endeavor (per 8 CFR 204.5(h)(2)), a high bar, but one that healthtech founders with significant achievements may be able to meet.
Qualifying evidence may include founding a well-funded healthtech startup; holding senior roles at recognized health technology companies; leading high-impact product launches or FDA approvals; earning salaries in the top tier (typically $200K+); or securing Y Combinator or top accelerator participation.
USCIS evaluates evidence across 10 criteria categories for the EB-1A (compared to 8 criteria for the O-1A), and applicants generally need to satisfy at least 3 of them. The EB-1A shares several criteria with the O-1A, making it a natural progression for founders who have built their evidentiary record through temporary visa status.
The EB-2 NIW provides a potentially more accessible green card path, requiring demonstration that the applicant's work benefits U.S. national interests enough to waive the standard employer sponsorship and labor certification requirements.
Healthcare innovation is recognized as a national priority area, and healthtech founders working on telemedicine platforms, AI diagnostics, and medical devices addressing public health challenges may be well-positioned for this category. Unlike the EB-1A, the NIW standard centers on "national benefit" rather than elite individual achievement.
Processing timeline: Approximately 14 to 21 months for standard I-140 processing as of early 2026 (check egov.uscis.gov/processing-times for current estimates). Premium processing is available at a 45-business-day adjudication window.
The NIW requires satisfying three prongs under the Matter of Dhanasar framework: substantial merit and national importance, positioning to advance the endeavor, and that it would benefit the United States to waive the job offer requirement. Alma's legal team helps healthtech founders build comprehensive petitions addressing each requirement.
The H-1B has historically been the default work visa for tech professionals, but 2025 policy changes have altered its economics for healthtech startups.
On September 21, 2025, a Presidential Proclamation fee of $100,000 took effect for certain new H-1B petitions requiring consular processing (this fee does not apply to all H-1B petitions; change-of-status petitions and extensions with the same employer are generally exempt). The fee is currently under judicial review. Immigration attorneys have described the impact as significant for early-stage companies.
Current H-1B costs for startups may include the $100,000 Presidential Proclamation fee (where applicable), a $780 base filing fee ($460 for small employers with 25 or fewer employees and nonprofits), a $500 fraud prevention fee, a $750 or $1,500 ACWIA training fee (based on employer size, with certain educational and research institutions exempt), a separate $4,000 surcharge for H-1B-dependent employers with 50 or more employees, and approximately 26 to 35% lottery selection odds per beneficiary under the current beneficiary-centric system (FY2025 and FY2026 data).
Despite the increased costs, the H-1B may remain relevant in specific scenarios. Cap-exempt employers such as universities, research hospitals, and nonprofits are not subject to the lottery. Established companies with existing H-1B programs and budget capacity may absorb the costs. And healthtech professionals joining funded companies (rather than founding their own) may find the H-1B a viable path through employer sponsorship.
For healthtech founders specifically, the O-1A, EB-2 NIW, and L-1A may offer more practical alternatives given the current fee structure.
Two additional visa categories serve healthtech founders with specific profiles: treaty country nationals and those with existing international operations.
The E-2 visa enables entrepreneurs from more than 80 treaty countries to operate U.S. businesses based on substantial investment. Key features include no annual cap or lottery (petitions may be filed at any time), historically high approval rates of 90 to 92.5% (based on State Department consular data), indefinite renewability while the business operates, and work authorization for the spouse.
The L-1A serves healthtech companies expanding from international headquarters to the U.S., a strategic trend particularly among Indian startups.
Key requirements include one year of employment at a foreign affiliate company within the preceding three years, executive or managerial capacity, and a qualifying corporate relationship between the foreign and U.S. entities.
Strategic features of the L-1A include no cap or lottery (petitions may be filed at any time), a maximum duration of up to 7 years, a direct path to the EB-1C green card (no PERM labor certification required; the beneficiary must have at least one year of qualifying managerial or executive employment abroad within the preceding three years), and availability to founders from any country, including India.
The L-1A may work particularly well for healthtech companies with established operations in Bangalore, Tel Aviv, London, or Berlin that need U.S. presence for FDA engagement, partnership development, or market expansion.
Canadian and Mexican healthtech professionals benefit from streamlined TN visa access under the USMCA (formerly NAFTA) agreement. The TN visa covers specific professional categories relevant to healthtech, including medical technologists, scientific technicians, health informaticists, and engineers. Processing is often same-day at the border for Canadian citizens. Government fees are minimal compared to other categories. Duration is up to 3 years, renewable in 3-year increments.
While TN does not offer the entrepreneur flexibility of the O-1A or E-2, it provides rapid market entry for healthtech professionals joining established companies, potentially before transitioning to other visa categories.
The complexity of healthtech founder immigration makes expert legal guidance an important consideration. A well-chosen immigration partner can assist with case strategy development (matching a founder's profile to appropriate visa categories), evidence compilation (documenting achievements in formats that satisfy USCIS adjudicators), RFE responses (addressing Requests for Evidence that can derail unprepared petitions), and pathway planning (sequencing temporary visas toward green card goals).
Alma's attorney-led platform combines legal expertise with technology-enabled workflows, delivering a 99%+ approval rate with a guaranteed 2-week document processing turnaround. The startup immigration plan specifically serves healthtech founders with streamlined processes, flat-rate pricing, and dedicated attorney consultation.
For healthtech companies scaling beyond founders, immigration compliance becomes an operational requirement. Alma's business immigration platform addresses this through scalable case management (from 5 to 5,000+ foreign nationals), compliance tracking (built-in trackers, proactive alerts, and audit-ready records), HRIS integration (connections with Workday, ADP, BambooHR, Rippling, and major systems), and employee portals (self-service document management and status visibility).
As healthtech companies grow, visa renewals, status changes, and green card sponsorship create ongoing obligations. Establishing compliant systems early can help prevent disruptions during critical growth phases.
No. Tourist visas (B-1/B-2) and ESTA explicitly prohibit work, including starting or operating a business. However, limited activities like attending meetings, exploring partnerships, or scouting office space may be permissible while planning an immigration strategy. Company formation through a Delaware C-corp is possible, but active management requires proper work authorization. The International Entrepreneur Parole program offers one potential pathway, requiring $311,071 or more in qualified U.S. investor funding (FY2025 inflation-adjusted threshold, effective October 1, 2024) and demonstrating significant public benefit potential.
Outcomes vary by visa category. O-1A holders may be able to transfer to a new employer or startup within the same field without losing status. E-2 investors must maintain their business to retain status; failure typically means returning home or transitioning to another category. L-1A holders may remain employed by the foreign parent company. The Canada Startup Visa historically offered a distinctive feature: PR status was not tied to startup success. However, the program is currently paused for new applications (with a limited grace period for holders of valid 2025 commitment certificates until June 30, 2026).
The O-1A and EB-1A do not require a PhD. For the O-1A, USCIS evaluates evidence across 8 criteria categories; for the EB-1A, there are 10 criteria categories. In both cases, applicants generally need to satisfy at least 3 of them. Healthtech founders commonly build their cases through significant VC funding demonstrating expert validation, patents on innovative technology, media coverage in trade publications, high salary relative to peers, critical roles at distinguished organizations, and original contributions evidenced by product impact or industry adoption. Strategic evidence compilation often matters more than formal credentials.
The UK Innovator Founder visa may be worth considering for founders prioritizing European market access or seeking alternatives to U.S. complexity. Unlike its predecessor, the current Innovator Founder visa (launched April 13, 2023) has no fixed minimum investment for the initial application; however, £50,000 invested and actively spent in the business is one of seven achievement criteria evaluated at the settlement stage (of which applicants must meet at least 2). The visa requires endorsement from an approved body confirming the business is innovative, viable, and scalable. It offers a path to settlement (indefinite leave to remain) after 3 years, subject to meeting the business achievement criteria. The U.S. healthtech market remains significantly larger, and the UK pathway requires hitting specific business milestones to maintain status.
Attorney fees vary by visa complexity. Alma's published pricing provides transparency: O-1A new petitions at $8,000, H-1B cap petitions at $3,500, L-1A initial/new office at $6,000, EB-1A/EB-2 NIW at $10,000 (or $7,000 with an approved O-1), and TN applications at $2,500 to $3,000. These fees typically cover attorney time, paralegal support, platform access, and administrative costs, though government filing fees are separate. For healthtech founders, working with experienced immigration counsel can contribute to faster processing and higher approval rates.
