MedTech Industry Pulse: July 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 July 2026.
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July 2026 at a Glance
- MedTech clinical trial starts held roughly steady at 79 in July, down slightly from 85 in June.
- Three notable acquisitions were announced: Tempus AI’s $1.5B purchase of Personalis, Mimedx’s $350M purchase of Sanara MedTech, and DePuy Synthes’s undisclosed acquisition of Expanding Innovations.
- Kestra Medical Technologies raised up to $200M in non-dilutive debt financing for its wearable cardioverter defibrillator platform.
- Regulatory activity moved on three fronts: FY2027 FDA user fees were published (premarket application $636,732; establishment registration $13,785), the EU’s Digital Omnibus entered into force, and China published 57 final device guidelines.
- A major market access shift landed: the FY2027 IPPS final rule, issued July 31, repeals the Breakthrough Devices route to alternative NTAP and TPT payment.
- FDA cleared 4 PMA and 5 De Novo approvals in July, bringing 2026 year-to-date totals to 27 PMA and 19 De Novo approvals.
July 2026 Funding Successes
| Company | Country | Funding Stage | Amount | Focus |
|---|---|---|---|---|
| Kestra Medical Technologies | USA | Non-dilutive debt | Up to $200M | Wearable cardioverter defibrillator & cardiovascular monitoring technologies |
| RapidPulse | USA | Series B | $48M | Neurovascular thrombectomy technology for ischemic stroke treatment |
| CoreMap | UK | Series C | $37M | Atrial fibrillation mapping & ablation technology |
| TYBR Health | USA | Growth financing | $30M | Bioresorbable hydrogel platform to reduce post-surgical adhesions |
| Epitel | USA | Series B | $26M | Wearable EEG monitoring and remote seizure monitoring platform |
| Xeltis | NLD | Equity financing | €20.5M | Bioresorbable vascular implants designed to regenerate blood vessels & improve cardiovascular outcomes |
| 410 Medical | USA | Growth financing | $12M | Emergency and critical-care rapid infusion devices |
| CARPL.ai | USA | Series A | $10M | Radiology AI and medical imaging platform |
| Throne Science | USA | Financing round | $10M | Biomarker monitoring and health analytics platform |
| Materna Medical | USA | Series B3 | $5M | Women’s health and obstetrical medical devices |
| En Carta Diagnostics | FRA | Financing round | €5M | At-home molecular diagnostics |
| PlaqueTec | UK | Financing round | $5M | Intracoronary liquid-biopsy & biomarker platform for coronary artery disease |
| Auxilium Health | USA | Seed | $3.4M | Biomaterials platform advancing toward FDA clearance |
| HTG Medical | FRA | Pre-Seed | €450K | ICU urine-output monitoring hardware |
| Hilo | CHE | Series B Extension | Undisclosed | Continuous blood pressure monitoring and cardiovascular insights platform |
Announced M&A
- Tempus AI acquired Personalis for $1.5B
- Mimedx acquired Sanara MedTech for $350M
- DePuy Synthes acquired Expanding Innovations for an undisclosed amount
Regulatory and Market Access Trends
Payment policy moved as fast as regulation across nearly every major MedTech market in July. Here is what shifted region by region, and what it means for regulatory strategy and submissions planning heading into the back half of 2026.
FY2027 fees were published July 30: the premarket application fee is $636,732 and the establishment registration fee is $13,785. MDUFA VI entered its public phase July 7, with a draft commitment letter published and docket opened; a public meeting is set for August 5, with the package due to Congress by January 15, 2027, ahead of MDUFA V’s expiration on September 30, 2027. Separately, SaMS replaced SaaS as the operative term in OPPS on July 2 and carried into PFS on July 14, with remote patient and therapeutic monitoring codes collapsing from 17 into four G-codes; comments are due September 14.
The Digital Omnibus entered into force July 27 as Regulation (EU) 2026/1744, published July 24. Standalone device AI deadlines under Annex III moved to August 2028, with the underlying obligation now shifting to December 2027; Article 50 transparency requirements still apply in the interim. Around five device Joint Clinical Assessments are expected in 2026, scoped to Class IIb and III devices with an expert panel opinion plus Class D IVDs (no IVDs appeared on the 2025 emerging technologies list). France also granted its first PECAN reimbursement for a therapeutic digital device in July; all prior grants under the scheme had been for remote monitoring only.
The WTO comment period closed July 7, and the MHRA’s own stakeholder survey (closed June 19) is now under analysis. The statutory instrument covering pre-market reform is expected in Q4 2026, with reliance routes following in Q2 or Q3 2028 and a transition period of three years for devices and five for IVDs. The specialised commissioning plan was also refreshed, adding four new policies in radiotherapy and orthopedics while two proton beam policies were dropped for insufficient evidence.
A Ministerial Reliance Order took effect July 15, letting Health Canada rely on comparable foreign regulator decisions for certain products; devices are not currently in scope. MDEL rules eased June 17, so foreign distributors will no longer need a Medical Device Establishment Licence to sell through licensed Canadian importers, effective December 14, 2026. Shortage reporting requirements were also widened under amendments to the Medical Devices Regulations.
NMPA published 57 final guidelines July 21, clarifying type testing, nonclinical and clinical evaluation, and submission expectations. New GMP requirements take effect November 1, 2026, and existing certificate holders may need a gap assessment beforehand. NMPA-reported Class III AI registrations now span pathology, endoscopy, and surgical navigation, though the agency has not published a product-level count.
Australia’s TGA opened consultation in July on bringing mental health apps and platforms offering assessment or therapy into scope. India’s CDSCO issued software guidance July 21 setting submission expectations for device software, including cloud and AI-based systems, and formalized an Algorithm Change Protocol, its analog to FDA’s predetermined change control plan, allowing predefined, bounded algorithm updates without a new licence application.
Market Access Deep Dive: The NTAP/TPT Rule Change
The single biggest market access story of the month: the FY2027 IPPS final rule, issued July 31, repeals the alternative pathway that let Breakthrough-designated devices reach New Technology Add-on Payment (NTAP) and Transitional Pass-Through (TPT) status. Sixteen of the 19 FY2027 NTAPs were granted through that Breakthrough Device Designation route, which closes to new applicants after September 30, 2026.
Two dates now anchor coverage strategy. Devices designated by September 30, 2026 keep alternative NTAP eligibility for FY2028 and FY2029 (TPT runs CY2028 and CY2029 and also requires marketing authorization for the designated indication). May 1, 2028 is the second gate: NTAP applicants must reach FDA authorization by their applicable deadline, and no later than that date.
CMS’s replacement is the RAPID Coverage Pathway, announced in April, with a procedural notice issued August 7. A proposed National Coverage Determination would publish the same day FDA authorizes an eligible device, targeting final coverage in roughly 60 days for Class II devices and 90 days for Class III, with sponsors entering the process at the IDE pre-submission stage. This is a meaningful shift for market access and reimbursement strategy planning: coverage strategy effectively now starts at the IDE pre-sub, not after FDA authorization.
The window to shape the new pathway is open now: the Transitional Coverage for Emerging Technologies (TCET) process is paused, with comments due October 13. IVDs are excluded from RAPID, and software only qualifies through the Class II TAP/De Novo or Class III PMA routes.
Clinical Trial Starts by Therapeutic Area
Interventional, industry-funded device trial starts came in at 79 in July, down slightly from 85 in June and continuing a gradual pull-back from the September 2025 peak of 117. Cardiovascular remains the clear leader, accounting for 24 percent of all trial starts July year-to-date at 163 starts, followed by neurology at 81 and musculoskeletal at 54. See Avania’s
Cardiovascular clinical trials experience for more on why this therapeutic area continues to lead, and Avania’s neurology experience given its position as the second-highest volume area this year.
FDA PMA Approvals, July 2026
- PGDx Elio Tissue Complete CDx (Personal Genome Diagnostics, Inc.): a qualitative next-generation sequencing-based in vitro diagnostic that uses high-throughput hybridization-based capture technology on DNA isolated from formalin-fixed paraffin-embedded tumor tissue.
- SimpleScreen CRC (Freenome, LLC): a qualitative in vitro diagnostic test that detects molecular signals associated with colorectal cancer using circulating cell-free DNA from a peripheral whole blood draw.
- TorEx Lung Perfusion System (Traferox Technologies, Inc.): indicated for continuous normothermic machine perfusion of donor lungs initially deemed unsuitable for transplantation, allowing ex vivo lung function to be reassessed for transplant suitability in adults.
- Belotero Intense (+) Lidocaine (Merz North America, Inc.): a hyaluronic acid dermal filler for deep facial lines, volume restoration, and lip enhancement, formulated with 0.3 percent lidocaine; results are described as typically lasting up to 12 months.
FDA De Novo Approvals, July 2026
- CaRi-Heart (Caristo Diagnostics, Ltd.): an AI solution that quantifies coronary inflammation and characterizes plaque from routine coronary CT angiography, generating an individualized risk score to aid diagnosis and management of coronary artery disease.
- OTTAVA Robotic Surgical System (Auris Health, Inc., part of Johnson & Johnson MedTech): described as the first table-integrated soft-tissue robotic surgery system, authorized for upper abdominal general surgery, with four robotic arms built into the operating table.
- SportSuite Vision Software (Stryker Endoscopy): an augmented reality system that runs on head-mounted displays to overlay real-time arthroscopic video and medical imaging into a surgeon’s field of view during procedures such as hip arthroscopy.
- TESSA Spatial Surgery System (Smith & Nephew): an augmented reality and AI-powered platform for arthroscopic sports medicine, authorized as the first device in a new category for intra-articular orthopedic stereotaxic navigation.
- Claria System (Claria Medical, Inc.): described as the first FDA-cleared integrated tissue containment and removal system built for minimally invasive hysterectomies, featuring electronic SafeStop technology and transvaginal extraction.
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.
The FY2027 IPPS final rule, issued July 31, repealed the alternative NTAP and TPT payment pathway for Breakthrough-designated devices. Devices designated by September 30, 2026 keep transitional coverage, and CMS’s new RAPID Coverage Pathway is intended to replace the closed route going forward.
Tempus AI’s $1.5B acquisition of Personalis and Mimedx’s $350M acquisition of Sanara MedTech were the two largest announced deals, alongside DePuy Synthes’s undisclosed acquisition of Expanding Innovations.
Catch up on the June 2026 MedTech Industry Pulse for last month’s AI oversight divergence and Q2 funding recap.
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