From September 21–27, 2026, the MedTech sector saw important developments spanning biocompatibility testing, Japan market entry, diagnostics reimbursement and large-scale investment in next-generation devices.
FDA focused on extraction methodology under ISO 10993-18, while Japan's PMDA updated its foreign manufacturer accreditation and registration list. New FDA clearances included a pressure-enabled delivery device for liver embolization and a 3D-printed knee system, while brain-computer interface developer Precision Neuroscience raised $250 million.
1. FDA Focuses on Extraction Methods for ISO 10993-18 Chemical Characterization
Published/Event date: September 23, 2026
FDA held an industry Town Hall on chemical characterization and extraction testing for medical-device biocompatibility. The session focused specifically on extraction approaches under ISO 10993-18, including common issues and practical examples.
FDA reiterated that devices with direct or indirect body contact should be evaluated under a risk-based framework aligned with ISO 10993-1, and that the agency intends its biocompatibility approach to be least burdensome for both manufacturers and reviewers. The Town Hall did not establish a new regulatory requirement, but it reinforces the importance of scientifically justified extraction conditions when chemical characterization is used to support a biological safety assessment.
For devices involving changes in materials, additives or manufacturing processes, the regulatory strategy increasingly depends on integrating existing information, chemical characterization and toxicological risk assessment rather than automatically repeating an entire battery of biological tests.
Official source
2. PMDA Updates Japan's Foreign Manufacturer Accreditation and Registration List
Published: September 24, 2026
Japan's PMDA updated its list of foreign manufacturers accredited or registered under the Pharmaceuticals and Medical Devices Act. The newly posted list reflects information current as of September 16, 2026, including foreign medical-device manufacturer registrations under Article 23-2-4 of the PMD Act.
PMDA notes that the published list reflects applications and notifications that had completed processing as of the compilation date. When preparing a foreign manufacturer registration or marketing authorization application, Japanese marketing authorization holders and importers are expected to confirm the manufacturer's current registration status directly with the overseas facility.
This is not a change in regulation, but it is operationally important for overseas manufacturers entering Japan. Registration status, manufacturing-site responsibilities and relevant registration numbers should be confirmed early in the Japanese regulatory pathway.
Official source
https://www.pmda.go.jp/review-services/drug-reviews/foreign-mfr/0003.html
3. CMS Publishes Preliminary 2027 Medicare Laboratory Rates, Averaging About 16% Lower
Published: September 21, 2026
The U.S. Centers for Medicare & Medicaid Services published preliminary Calendar Year 2027 Clinical Laboratory Fee Schedule rates based on private-payor data reported in 2026. Across applicable codes, the preliminary weighted-median rates are approximately 16% lower on average than the corresponding 2026 CLFS rates.
Of 1,528 codes with a private-payor weighted median, 1,171 were below their 2026 Medicare rate. Estimated changes include approximately -22% for molecular pathology, -23% for genomic sequencing and -19.3% for microbiology. Statutory protections limit annual reductions to 15% during 2027–2029, so decreases will be phased in. Final 2027 rates are expected in November and will take effect January 1, 2027.
For IVD and molecular-diagnostic manufacturers, reimbursement can be as important to commercial viability as regulatory authorization. The proposed changes may affect pricing assumptions and U.S. market-access strategies for both existing and emerging tests.
Official source
4. TriSalus Receives FDA Clearance for TriNav Advance Liver-Directed Delivery System
Published: September 22, 2026
TriSalus Life Sciences announced FDA 510(k) clearance for TriNav Advance, the latest addition to its Pressure-Enabled Drug Delivery platform. The system can be paired with a compatible microcatheter to access smaller distal vessels while maintaining the company's pressure-enabled delivery approach.
The platform is intended to support liver-directed therapy and has an indication covering a broader range of embolization procedures beyond the liver. TriSalus plans a limited market release over the coming weeks.
In liver-directed intervention, differentiation is increasingly driven not only by the therapeutic or embolic material itself but also by how selectively and consistently it can be delivered to the target vasculature.
Official source
5. Smith+Nephew Wins FDA Clearance for 3D-Printed LANDMARK Knee System
Published: September 22, 2026
Smith+Nephew announced FDA 510(k) clearance and the first surgical case for its LANDMARK Total Knee System, a next-generation knee replacement platform designed around healthy knee anatomy and natural motion.
The system includes a fully 3D-printed femoral component using CONCELOC technology and was designed to leverage Smith+Nephew's CORI KNEE Handheld Robotics Arthroplasty platform. A phased commercial introduction is underway, with broader availability expected through 2027.
The launch reflects a broader trend in surgical robotics: competition increasingly centers on the complete ecosystem of implants, instruments, planning and navigation rather than the robot itself.
Official source
6. GE HealthCare and Mass General Brigham Explore Generative AI for Radiation Therapy
Published: September 23, 2026
GE HealthCare expanded its research collaboration with Mass General Brigham to explore generative AI in radiation oncology. The teams aim to combine structured clinical data and unstructured information such as notes, images and treatment plans, allowing clinicians to query and retrieve relevant information across a patient's treatment journey.
The work could eventually inform future capabilities in GE HealthCare's Intelligent Radiation Therapy workflow platform. Earlier collaboration between the organizations produced technology that, according to research cited by GE HealthCare, reduced intake-to-treatment time in some workflows from as long as 30 days to eight days.
The newly announced generative-AI capability is research-stage technology, not a newly authorized medical device. It nevertheless illustrates how clinical AI is expanding beyond image interpretation toward orchestration and synthesis of complex treatment workflows.
Official source
7. Anaconda Biomed Raises $56 Million for Stroke Thrombectomy Platform
Published: September 23, 2026
Anaconda Biomed announced the closing of a $56 million financing round led by Omega Funds. Proceeds will support completion of the ATHENA pivotal IDE study for the ANA Funnel Catheter, continued product development and regulatory activities across global markets.
ATHENA is a prospective randomized study expected to enroll 327 subjects. The ANA Funnel Catheter remains investigational in the United States, while the ANA5 Funnel Catheter is CE-marked. The company's platform is being developed across mechanical thrombectomy, aspiration-first stroke treatment and carotid interventions.
The financing is another example of MedTech investors funding the entire path from pivotal IDE trials through regulatory review and international commercialization rather than an isolated R&D program.
Primary source
8. Precision Neuroscience Raises $250 Million Series D for Brain-Computer Interface Development
Published: September 24, 2026
Precision Neuroscience announced an oversubscribed $250 million Series D, bringing total capital raised to $430 million. The company says its technology has now been used in more than 100 patient procedures across 18 medical institutions.
The funding will expand clinical programs, advance the Layer 7 Cortical Interface through further FDA review and build commercialization infrastructure. Although Precision reports FDA clearance for its Layer 7 Cortical Interface, its website continues to state that its brain-computer interface is investigational and is not available for sale in the United States.
The size of the round illustrates how BCI is moving from a purely experimental technology field toward a phase that requires simultaneous investment in clinical evidence, regulation, manufacturing and commercial infrastructure.
Primary source
9. Safety: FDA Classifies Boston Scientific Imager II Catheter Recall as Class I
FDA update: September 25, 2026
FDA classified the removal of certain Boston Scientific Imager II Angiographic Catheters as a Class I recall. A manufacturing issue resulted in reduced levels of stabilizing agents in the catheter tips, potentially increasing the risk of tip degradation and detachment.
Tip detachment can require interruption of a procedure and device exchange and, in rare circumstances, may result in life-threatening embolism if a fragment obstructs blood flow. As of July 16, 2026, two serious injuries and no deaths had been reported. Boston Scientific has instructed customers to stop use and distribution of affected products and has also decided to discontinue the product.
This is the only major safety item included this week, keeping the brief focused on regulatory, reimbursement, innovation and business developments.
Official source
Summary
This week's developments highlight why MedTech companies increasingly need to manage materials evaluation, regulatory strategy, reimbursement and financing as one connected product lifecycle.
FDA's biocompatibility Town Hall put renewed attention on chemical characterization and extraction methodology, while PMDA updated information that overseas manufacturers need when preparing Japanese market entry. In the U.S., substantial preliminary changes to Medicare laboratory payment rates also demonstrate how commercial viability can shift after regulatory authorization.
At the technology level, selective liver delivery, 3D-printed implants, robotic surgery, generative AI, stroke intervention and brain-computer interfaces continue to attract both regulatory activity and major investment.