MedTech Industry Pulse: March 2026
Avania’s monthly briefing on the trends shaping MedTech regulatory strategy, funding, and market access, part of our MedTech insights and resources library. Here’s what mattered in March 2026 and across Q1 2026.
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March 2026 at a glance
- MedTech clinical trial starts reached 358 in Q1 2026, a 29 percent increase over Q1 2025. Cardiovascular, neurology, ophthalmology, and oncology together account for 48 percent of all study starts year to date.
- Half of all Q1 2026 study starts were exploratory or pilot studies, and fewer than 5 percent were pivotal trials.
- LSI and JP Morgan tracked $2.4B and $2.5B of MedTech venture capital deals in Q1 2026, respectively.
- WHOOP raised $575M at a $10.1B valuation in a Series G round led by Collaborative Fund.
- Neuromodulation gained momentum, with raises from Cognito Therapeutics, Neurolief, and Aneuvo.
- FDA granted four PMA approvals, to LivaNova, JenaValve, Boston Scientific, and Perimeter Medical Imaging AI, plus two De Novo approvals, to TytoCare and LifeVac.
- 744 510(k)s were filed in Q1 2026, flat against Q1 2025.
MedTech Funding Trends, Q1 2026
Q1 2026 funding reached $2.5B, up $0.2B from Q4 2025 but down $1.9B from Q1 2025, across 79 deals averaging $31.65M each.
Q1 2026 funding reached $2.4B across 78 deals averaging $30.77M each, down 33 percent from Q1 2025’s $3.6B. Comparing the Q4 2024 through Q2 2025 window ($8.85B across 438 deals) to the Q3 2025 through Q1 2026 window ($7.9B across 245 deals) shows a 44 percent drop in the number of companies receiving funding. After normalizing for the Q2 2025 Neuralink deal, however, overall funding across the two windows is similar, $8.25B versus $7.9B, while average deal size has grown from $18.8M to $32.3M.
MedTech Companies With Funding Reported in March 2026
| Company | Country | Stage | Focus | Amount |
|---|---|---|---|---|
| WHOOP | USA | Series G | Wearable health and fitness tracker | $575M |
| Cognito Therapeutics | USA | Series C | Neuromodulation | $105M |
| Vitestro | Netherlands | Series B | Autonomous robotic phlebotomy device | $70M |
| Lenoss Medical | USA | Bridge Round | Cementless biologic implant for spinal fracture | $60M |
| Thrombolex | USA | Series A | Interventional devices | $50M |
| Endogenex | USA | Series C | Endoscopic pulsed electric field solution for Type 2 diabetes | $50M |
| Hyperfine | USA | Debt Financing | Portable brain MRI system | $40M |
| Neurolief | USA | Growth | Neurostimulation | ≈$40M |
| ProSomnus Sleep Tech | USA | Series B | Oral device | $38.0M |
| Nuvaira | USA | n/a | Respiratory therapeutics | $35.8M |
| XCath | USA | Series C | Endovascular robotics and steerable guidewires | $30M |
| Monteris Medical | USA | Series E | Precision-guided laser therapy for brain tumors and epileptic foci | $28M |
| Echopoint Medical | UK | Other | Optical fiber ultrasound sensors for cardiovascular disease | $25M |
| Aneuvo | USA | Series C | Neuromodulation | $22M |
| Minnesota Medical Tech | USA | Series A | Medical device innovation | $20.6M |
| Petal Surgical | USA | Bridge Round | Incisionless surgery platform | $15M |
| Abram Scientific | USA | Series A | Coagulation device | $11.75M |
| HEPTA Medical | France | Series A | Minimally invasive non-surgical treatment for early lung cancer | $11.55M |
| Bioliberty | USA/UK | Series A | Assistive device and platform for hand weakness | $10.2M |
| Sub-Q Bionics | USA | Seed | Implantable | ≈$5-10M |
| Noah Labs | USA/Germany | Grant | AI-based remote patient monitoring for cardiovascular health | $3.47M |
Q1 2026 planned and completed M&A
| Buyer | Target | Approx. Value / Focus |
|---|---|---|
| Smith & Nephew | Integrity Orthopaedics | ≈$450M, rotator cuff repair devices |
| Boston Scientific | Valencia Technologies | Neuromodulation tech |
| BioStem Technologies | BioTissue Surgical & Wound Care | ≈$15M plus milestones, surgical and wound care products |
| W. L. Gore & Associates | Conformal Medical | Structural heart implants |
| Haemonetics | Vivasure Medical | ≈€185M, vascular closure devices |
| Resonetics | Resolution Medical | Expands structural heart and neuromodulation design and manufacturing |
| Boston Scientific | Penumbra | ≈$14.5B, vascular and neuro devices |
| Alkem MedTech | Occlutech | €99.4M, structural heart implants |
| BD & Waters | n/a (combination) | Diagnostics and biosciences |
| Medtronic | CathWorks | ≈$585M, cardiac devices |
| Precision IO Group / Quantum Surgical | NeuWave Medical | Robotics plus tumor ablation tech |
| Zavation | ChoiceSpine | Spine devices |
| GCM | Kettmann Machining | Precision MedTech manufacturing |
| Maxx Orthopedics | TracPatch | Remote orthopedic monitoring |
| Danaher | Masimo | $9.9B, patient monitoring |
| Guardant Health | MetaSight | $59M, diagnostics |
| Tactile Medical | LymphaTech | $6.8M plus milestones, lymphedema digital and device |
| Abbott | Exact Sciences | $21B, cancer screening |
| Medtronic | Scientia Vascular | $550M, neurovascular |
| Merit Medical | View Point Medical | $140M, tumor tissue localization devices |
| Embecta | Owen Mumford | $201M, drug delivery systems |
Regulatory and Market Access Trends
HHS restructuring announced March 27 cut roughly 3,500 FDA positions and reduced the Office of the Chief Information Officer by 40 percent, including leadership exits from the Digital Health Center of Excellence. Section 524B cybersecurity requirements are converging with QMSR, making cybersecurity an auditable finding; 524B refusals are climbing and SBOM documentation now gates 510(k) acceptance. CMS’s TCET pathway expanded, opening transitional coverage slots for breakthrough devices, a change worth building into market access and reimbursement strategy planning. Separately, QMSR is now fully live alongside a new FDA audit program, described as the biggest quality shift in 30 years, and CDRH released strategic priorities centered on AI/ML lifecycle management and total product lifecycle programs affecting all legacy devices.
The European Parliament voted March 26 to decouple medical AI from the AI Act’s high-risk AI systems classification, providing immediate relief for SaMD developers, though the European Commission retains the power to reinstate that classification later. EUDAMED becomes mandatory May 28, 2026, with Actor Registration, UDI and Device modules, Notified Body certificates, and Market Surveillance all going live in the final 60-day countdown. NIS2 enforcement is now active, classifying medical device manufacturers as essential entities in scope for incident reporting and supply chain attestations. Targeted MDR and IVDR simplification is expected to begin in Q2, a likely flashpoint for legacy devices, a dynamic worth flagging for anyone building out regulatory strategy and submissions plans that touch legacy EU device families.
The MHRA ran a consultation on indefinite CE-mark recognition from February 16 to April 10, described as the biggest change to the UK’s medical device framework since Brexit, and confirming international reliance routes for FDA, Health Canada, TGA, and EU approvals. The MHRA also signaled new adaptive AI guidance, potentially similar to the FDA’s Predetermined Change Control Plan, expected in the second half of the year, alongside published results from AI Airlock Cohort 2.
Globally aligned GMP reform is stimulating manufacturing reshoring into China, as ISO 13485, EU MDR, and FDA QMSR alignment drive CMO and CRO requalification. NMPA Announcement No. 24, issued March 17, introduced 26 new standards, including YY/T 1406-2026, which unifies software safety, cybersecurity, and AI/ML and robotics requirements.
New hospital adverse event reporting rules, effective March 21, carry a penalty of roughly $9,900 per incident; all public, private, and day hospitals must now report Class III device and Class 4 IVD related deaths and serious deterioration to the TGA or face that fine. The TGA’s AI and SaMD guidance operational framework is now live and required for filings, with SaMD prioritized as a key focus area in the TGA’s 2026 to 2027 strategy.
PMDA-FDA equivalent authority took effect May 1, giving US-cleared devices with Japanese predicates priority review and tightening US-Japan development connections. Japan’s IDATEN adaptive AI framework continues expanding, with roughly 100 AI-enabled SaMDs now approved and a continuous-learning pathway maturing as the country incentivizes AI and machine learning development.
Cybersecurity Transformation, Q1 2026
The newsletter frames Q1 2026 as a turning point in MedTech cybersecurity, driven by three developments the source material describes as a signal that FDA’s Section 524B cybersecurity submission requirement is no longer sufficient against this class of attacker.
- A cyberattack on Stryker, reported March 11, is described as using a legitimate cloud device-management tool to wipe roughly 80,000 devices across 79 countries without deploying traditional malware, including downtime for Stryker’s LIFEPAK Net (Lifenet) electrocardiogram system. The source material frames this as evidence that cloud device management itself is now an attack surface.
- On April 7, Anthropic released a new AI model referred to as Mythos, alongside a cybersecurity research initiative described as “Project Glasswing” involving a consortium that reportedly includes AWS, Google, Microsoft, CrowdStrike, and the Linux Foundation. The source material states this initiative disclosed thousands of previously unknown vulnerabilities, with 99 percent still unpatched at time of writing.
- The source material also states that, for under $50 in compute cost, this AI model autonomously found and exploited a 27-year-old OpenBSD bug and a 17-year-old FreeBSD remote-root vulnerability, framing this as evidence that every connected medical device on the market today was cleared without defenses against this class of AI-driven attacker.
In response, standards bodies have moved to update cybersecurity expectations: AAMI’s CR515:2025 was recognized by FDA on February 19 as the first AI/ML device cybersecurity consensus standard. CISA and HSCC are previewing 2026 healthcare AI cybersecurity guidance that extends secure-by-design expectations to agentic AI systems. NIST’s post-quantum cryptography transition, alongside NIS2 enforcement in the EU, is compounding compliance requirements for connected medical devices.
Clinical Trial Starts, Q1 2026
Interventional, industry-funded device trial starts reached 358 in Q1 2026, a 29 percent increase over Q1 2025’s 277, and the highest quarterly total in the two-year trend reported. Half of all Q1 2026 study starts were exploratory or pilot studies, followed by comparative effectiveness studies at 14.2 percent and diagnostic validation studies at 13.5 percent; pivotal IDE studies made up only 4.5 percent of starts. By therapeutic area, cardiology and vascular led with 59 study starts, followed by neurology and neuroscience at 46, oncology at 33, and ophthalmology at 31; together, cardiovascular, neurology, ophthalmology, and oncology represent 48 percent of all study starts year to date. See Avania’s cardiovascular clinical trials experience for more on how this therapeutic area is trending.
FDA PMA Approvals, March 2026
- aura6000 system (LivaNova): indicated for the reduction of apneas, hypopneas, or both, in adult patients with moderate to severe obstructive sleep apnea.
- Trilogy Transcatheter Heart Valve System (JenaValve Technology): indicated for the treatment of symptomatic, severe native aortic valve disease in patients judged by a Heart Team, including a cardiac surgeon, to be at high or greater risk for surgical aortic valve replacement.
- Rebel Platinum Chromium Coronary Stent System, Monorail and Over the Wire (Boston Scientific): indicated for improving coronary luminal diameter in patients with de novo lesions in native coronary arteries, within the reference vessel diameter range specified in the FDA approval.
- Claire OCT System (Perimeter Medical Imaging AI): intended for use alongside other standard methods to evaluate the margins of excised lumpectomy tissue during surgical procedures in patients with a biopsy-confirmed breast cancer diagnosis.
FDA De Novo Approvals, March 2026
- Tyto Insights for Eardrum Bulging Detection (Tyto Care): an over-the-counter, web-based, AI-enabled software analytics device that automatically detects eardrum bulging in otoscopic video recordings captured with a compatible electronic otoscope, for patients aged 6 months and older.
- LifeVac (LifeVac, LLC): a non-powered, non-invasive, single-use airway clearance device intended to resolve choking from a complete airway obstruction when a current choking protocol has been followed without success.
510(k) Filing Trend
744 510(k)s were filed in Q1 2026, flat against Q1 2025’s 744 and continuing a pattern of comparatively low Q1 filing volumes relative to surrounding quarters, which saw 812 filings in Q4 2025 and 884 in Q2 2025.
Frequently Asked Questions
It’s Avania’s monthly briefing on MedTech regulatory changes, funding trends, clinical trial activity, and M&A, built for device, diagnostic, and digital health companies tracking the global landscape.
JP Morgan tracked $2.5B in Q1 2026 MedTech venture funding across 79 deals, while LSI tracked $2.4B across 78 deals; both trackers show funding down from Q1 2025.
FDA’s Section 524B cybersecurity requirements are converging with QMSR, making cybersecurity an auditable finding, while new AI-driven vulnerability research is prompting standards bodies like AAMI, CISA, and NIST to update secure-by-design expectations for connected devices.
Catch up on the April 2026 MedTech Industry Pulse for the latest on the RAPID Coverage Pathway and Q2 M&A activity.
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