Reporting Period: June 29 - July 5, 2026
In the global medical device and MedTech news from the last week of June to the first week of July 2026, we observed significant activity regarding new product launches, FDA 510(k) clearances, commercial introductions following CE Mark approval, first-in-human uses, and initial clinical cases.
Notably, highlights include Roche's next-generation sequencing platform, Edwards Lifesciences' left atrial appendage (LAA) occlusion clip, StarMed's radiofrequency ablation system for thyroid nodules, Terumo's intracoronary imaging system, Nitinotes' suture system for endoscopic sleeve gastroplasty, OrthAlign's joint replacement navigation for ASCs, and Peytant's tracheal and bronchial covered stents.
Meanwhile, there were also important news items concerning safety, regulation, and M&A, such as Terumo's Class I recall of a thoracic stent graft (including cases with multiple reported patient deaths), an FDA warning letter to BMC Medical, and Zimmer Biomet's acquisition of a non-opioid pain management device.
Main News
1. Roche Launches Next-Generation Sequencing Platform "AXELIOS 1"
Roche has launched its next-generation sequencing platform, "AXELIOS 1." AXELIOS 1 is introduced as a next-generation sequencer utilizing the company's proprietary sequencing by expansion (SBX) technology. Initially, it will be offered for Research Use Only and is not positioned for diagnostic purposes. Reports indicate that the unit price in the U.S. is approximately $750,000, which is set lower than Illumina's NovaSeq X (approximately $985,000 to $1.25 million), with an estimated sales target of around 100 units in the first year.
While Illumina holds a strong presence in the sequencing market, Roche's introduction of a new platform could further intensify competition, spanning from research applications to potential future clinical use. The importance of sequencers in the diagnostic and testing device sector is growing, encompassing genomic analysis, cancer gene testing, rare disease diagnosis, and infectious disease analysis.
From the perspective of medical devices and in vitro diagnostics, it is crucial to build an ecosystem that includes not only device performance but also sample pre-processing, analysis software, data management, clinical validity, and reimbursement. If a device initially launched for research purposes is later expanded to clinical applications, separate regulatory compliance will become a critical issue.
Source: Roche - AXELIOS 1 launch
2. Edwards Lifesciences Obtains FDA 510(k) Clearance for "Ecliptis" Left Atrial Appendage Exclusion Clip
Edwards Lifesciences has obtained FDA 510(k) clearance for its left atrial appendage exclusion device, the "Ecliptis Left Atrial Appendage Exclusion System." The device's listing in the FDA database is dated June 26. Edwards reportedly mentioned the device at an investor event in December 2025 and submitted its application on December 29 of the same year.
Ecliptis is an implantable clip designed to close the left atrial appendage during associated cardiac surgical procedures. Left atrial appendage exclusion is a field related to reducing thrombus formation and stroke risk in patients with atrial fibrillation. Direct competitors for surgical clips include AtriCure's AtriClip and Medtronic's Penditure. Additionally, Boston Scientific and Abbott offer minimally invasive (percutaneous) left atrial appendage exclusion devices, making it a highly competitive market, even when considering adjacent areas. Following the approval news, AtriCure's stock price reportedly fell by approximately 7%.
Edwards holds a strong position in the structural heart disease sector, primarily with TAVR. The introduction of Ecliptis represents a move by the company to expand into the adjacent field of left atrial appendage exclusion, leveraging its customer base in surgical heart valve procedures and structural heart disease. Edwards has indicated a plan for a measured and limited market introduction in 2026.
Sources: MedTech Dive - Edwards wins FDA clearance for LAA clip FDA 510(k) database
3. StarMed Receives FDA 510(k) Clearance for Radiofrequency Ablation System for Thyroid Nodules
StarMed America has obtained FDA 510(k) clearance (510(k) number: K252833, effective May 26, 2026, announced June 30) for its devices used in radiofrequency ablation (RFA) of thyroid nodules. The company states it is the first to receive FDA clearance for thyroid nodule RFA indications in the U.S. The devices covered are the VIVA combo RF generator, STAR RF electrode, and VIVA RF electrode, indicated for ultrasound-guided percutaneous ablation of cytologically confirmed benign thyroid nodules in adults.
RFA for thyroid nodules can be a less invasive alternative to surgery for benign nodules that cause symptoms or cosmetic concerns. Compared to surgical excision, it offers potential patient benefits such as outpatient treatment, reduced scarring, and preservation of thyroid function.
In the U.S., the Centers for Medicare & Medicaid Services (CMS) established CPT codes 60660 and 60661 for thyroid RFA effective January 1, 2025. The prior establishment of a reimbursement framework could further accelerate its adoption. When considering introduction in Japan, key discussion points would include indications, physician and facility requirements, positioning relative to existing treatments, and insurance reimbursement.
Sources: MassDevice - StarMed wins FDA clearance for RF ablation platform for thyroid nodules Endovascular Today - StarMed America Receives FDA Clearance
4. Terumo Performs First U.S. Procedure with OPUSWAVE Coronary Intravascular Imaging System
Terumo Interventional Systems announced that it has performed the first U.S. procedure using the OPUSWAVE Dual Sensor Imaging System. The procedure was conducted on June 15 by Dr. Annapoorna S. Kini at Mount Sinai Fuster Heart Hospital in New York. OPUSWAVE is a coronary intravascular imaging system designed to combine the deep vessel visualization of IVUS with the high-resolution surface imaging of OFDI in a single DualView catheter. It received FDA 510(k) clearance in October 2025. Terumo is a division of Terumo Corporation (TSE:4543) in Japan.
In coronary interventions, intravascular imaging is crucial for lesion assessment, determining stent size and length, confirming stent expansion, and identifying complications. Since IVUS and OFDI/OCT each have different strengths, dual-sensor systems are attracting attention as a new approach to support PCI decision-making.
From the perspective of new product introduction, widespread adoption will depend not only on the ability to visualize images, but also on integration into existing cath lab workflows, education on image interpretation, impact on procedure time, and reimbursement considerations.
Sources: Terumo - OPUSWAVE first procedure in the United States MassDevice - Terumo reports first procedure using dual-sensor imaging system in US
5. Nitinotes Conducts First Commercial Cases of EndoZip in France
Nitinotes announced that it has conducted its first commercial cases of the EndoZip Automated Suturing System in France. The procedures were performed under the supervision of Professor Silvana Perretta at IHU Strasbourg (Institute of Image-Guided Surgery) in Strasbourg. EndoZip is an automated suturing system used for endoscopic sleeve gastroplasty (ESG).
In the field of obesity treatment, surgical procedures, endoscopic treatments, and pharmacotherapy are all advancing. Endoscopic devices like EndoZip are expected to offer a less invasive alternative to surgery, reducing patient burden and shortening recovery times.
The product has obtained CE Mark approval in Europe (November 2025), and these commercial cases in France are part of its European expansion, following its use in Italy and Spain. In the United States, EndoZip is still in the investigational stage, with a multi-center randomized controlled trial (EASE study, IDE) currently underway. Globally commercialized endoscopic gastric remodeling (EGR) platforms include OverStitch (Boston Scientific), IOP (USGI Medical), Endomina (Endo Tools Therapeutics), and the latest, EndoZip (Nitinotes). In the field of gastrointestinal endoscopy, the widespread adoption of these devices depends on therapeutic devices, procedural training, facility implementation systems, and the presentation of long-term outcomes.
Sources: Nitinotes - First commercial EndoZip cases in France Bariatric News - First commercial EndoZip ESG cases performed in France
6. OrthAlign Completes First Cases with Joint Replacement Navigation System "Lantern ASC"
OrthAlign announced that it has completed its first clinical cases for Lantern ASC, a joint replacement surgical assistance system designed for Ambulatory Surgical Centers (ASCs).
Lantern ASC consists of a reusable navigation unit and a procedure-specific Smart Pack Kit, providing real-time navigation for total knee arthroplasty, partial knee replacement, and ligament balancing. The system is designed with ASC adoption in mind, as it does not require the large capital investment or dedicated space typically associated with large robotic systems.
In the U.S., there is a growing trend of joint replacement surgeries shifting to ASCs. Consequently, surgical assistance technologies are now required to offer not only precision but also ease of installation, cost-effectiveness, quick surgical turnaround, and compatibility with existing workflows.
Sources: MassDevice - OrthAlign announces first cases with joint replacement tech for ASCs Orthoworld - OrthAlign Announces First Cases with Lantern ASC System
7. Peytant Solutions Performs First Human Use of AMStent Tracheobronchial Covered Stent
Peytant Solutions announced the first human use of its AMStent Tracheobronchial Covered Stent System. The AMStent is introduced as a covered stent for tracheobronchial stenosis, covered with human-derived amniotic membrane.
Tracheobronchial stents are sometimes used to relieve airway obstruction caused by malignant tumors or stenosis. For covered stents, key evaluation criteria include the covering material, tissue reaction, risk of migration, granulation formation, ease of removal, and long-term safety.
At the stage of first human use, unlike commercially available products, clinical experience is limited. Moving forward, it will be crucial to accumulate data on safety, procedural success rates, symptom improvement, stent patency, and complications.
Source: MassDevice - Peytant announces first human use of tracheobronchial covered stent system
8. Alafair Biosciences Launches VersaCoat Flowable Hydrogel
Alafair Biosciences has launched VersaCoat Flowable Hydrogel, a product designed for soft tissue protection in orthopedic surgery. This syringe-delivered, bioresorbable hydrogel aims to reduce postoperative soft tissue adhesions and tethering in tendons, ligaments, skeletal muscles, peripheral nerves, and the perineural environment.
The company utilizes its VersaCore Hydrogel Technology, based on hyaluronic acid and alginate, offering a formulation that is easier to apply to hard-to-reach anatomical areas compared to traditional sheet-form products.
In orthopedic, hand, foot and ankle, and peripheral nerve surgeries, postoperative adhesions and reduced tissue gliding can impact functional recovery. Key evaluation points for surgical adjuncts include ease of use, application site, absorbability, safety, and impact during reoperation.
Source: Alafair Biosciences - Launch of VersaCoat Flowable Hydrogel
9. Penumbra Receives CE Mark for Red 72 Silver Label Reperfusion Catheters
Penumbra announced that it has received CE Mark approval for its Red 72 Silver Label and Red 72 Silver Label with SendIt technology, both indicated for acute ischemic stroke.
In the neurovascular field, the evolution of thrombectomy devices continues. Competition revolves around aspiration catheters, stent retrievers, access devices, deliverability, clot capture capability, and reduction in procedure time. This CE Mark approval could lead to an expansion of stroke treatment device options in the European market.
Source: Endovascular Today - Penumbra's Red 72 Silver Label Reperfusion Catheters Receive CE Mark Approval
10. Reflow Medical Announces First Patient Enrollment in New Trial for Spur Peripheral Retrievable Scaffold System
Reflow Medical has announced the first patient enrollment in the DEEPER CHALLENGE trial, which evaluates the Spur Peripheral Retrievable Scaffold System. The trial assesses early vessel recoil after treatment for below-the-knee lesions in patients with critical limb ischemia (CLI) or chronic limb-threatening ischemia (CLTI).
Spur is a concept designed to temporarily form a scaffold within the vessel and enhance treatment efficacy when used in conjunction with a drug-coated balloon. Unlike permanently implanted stents, its distinguishing feature is that it is a retrievable scaffold.
In the peripheral vascular domain, calcification, restenosis, vessel dissection, long-term patency, and limb salvage are critical challenges. New device concepts must demonstrate clear benefits compared to existing treatments through clinical trials.
Source: Reflow Medical - DEEPER CHALLENGE trial first patient enrollment
11. Zimmer Biomet to Acquire Pacira's iovera Pain Management Device for up to $140 Million
Zimmer Biomet announced an agreement to acquire the non-opioid pain management device "iovera" from Pacira BioSciences for up to $140 million (June 30). The agreement consists of a $70 million upfront payment and up to $70 million in sales-based milestones through December 31, 2031. The milestones are structured as tiered payments of $18.5 million, $23.5 million, and $28 million when iovera's annual net sales reach $50 million, $60 million, and $70 million, respectively. Approximately 66 Pacira employees (about 8% of the company's workforce) are expected to transition to Zimmer Biomet. The transaction is anticipated to close in the third quarter of 2026.
Iovera is a cryoneurolysis device that temporarily blocks pain signals in peripheral nerves through cooling. It is positioned as a technology relevant to pain management in orthopedic surgery, joint replacement, and osteoarthritis.
This acquisition represents a move by Zimmer Biomet to expand its business scope in the orthopedic field, moving beyond implants alone to encompass perioperative management, pain management, and improving patient outcomes. Non-opioid pain management is an area that garners significant attention in the U.S. due to healthcare policies and reimbursement, such as the NOPAIN Act (reimbursement incentives for non-opioid pain treatments, effective 2025).
Sources: MedTech Dive - Zimmer to buy Pacira pain relief device for up to $140M MassDevice - Zimmer Biomet to pay up to $140M for Iovera nerve therapy tech
12. Aurenar Receives FDA Breakthrough Device Designation for Non-Invasive Neuromodulation "V-Link"
Aurenar has received FDA Breakthrough Device designation for its non-invasive neuromodulation system, "V-Link," which aims to reduce cerebral vasospasm after subarachnoid hemorrhage.
V-Link is described as a device that delivers low-energy electrical stimulation to branches of the vagus nerve via the periauricular region. In subarachnoid hemorrhage following cerebral aneurysm rupture, secondary cerebral vasospasm can be a serious complication.
While Breakthrough Device designation is not an approval, it is a program that allows for accelerated development through interaction with the FDA for promising technologies addressing serious conditions. In the neurotech field, the development of less invasive neurostimulation devices is progressing.
Source: MassDevice - Aurenar gets FDA breakthrough nod for noninvasive neuromod tech NeuroNews International - Aurenar gains FDA breakthrough designation
13. Terumo Initiates Voluntary Recall of Relay Pro Thoracic Stent-Graft (Class I Recall)
While there is much news related to new products, the voluntary recall of Terumo's Relay Pro Thoracic Stent-Graft System is a significant safety and recall-related event. Terumo announced the global voluntary recall on July 1st.
The recall affects certain models of the Relay Pro NBS (Non-Bare Stent) (diameters 32mm-46mm), due to the potential for the delivery system to not properly detach after stent-graft deployment. In four reported cases from overseas medical institutions, the delivery system could not be removed from the patient's body after deployment, and in three of these cases, the patient died during or after the procedure. Terumo states that a direct causal relationship between the device and these events has not been established at this time.
Approximately 7,000 units sold between May 2024 and March 2026 are affected, having been distributed to a total of 43 countries across North America, Central and South America, Europe, the Middle East, and Asia. In the United States, the product is sold by Bolton Medical (acquired by Terumo in 2017 for approximately $174 million, now Terumo Aortic), and the FDA issued an early warning in April, classifying it as a Class I recall, the most serious category, in May. Prior to this, a voluntary recall of the same model had already begun in Japan on June 1st, and it is stated that there are no changes to its scope or content.
For high-risk cardiovascular implants, not only the device itself but also the delivery system, detachment mechanism, and intraoperative maneuverability are critical safety considerations. Post-market surveillance, analysis of complaint information, field actions, and a system for providing information to medical institutions are all crucial.
Source: Terumo - Voluntary recall of Relay Pro Thoracic Stent-Graft System MedTech Dive - Terumo recalls stent-graft system linked to three deaths FDA - Thoracic Stent Graft Recall: Bolton Medical Removes Relay Pro System
14. FDA Issues Warning Letter to BMC Medical for CPAP/APAP Devices
The FDA has issued a warning letter to China's BMC Medical regarding its CPAP/APAP devices. According to reports, the FDA has indicated that some of the company's devices may not have undergone appropriate premarket procedures, despite changes from their existing 510(k) clearance potentially affecting their safety and effectiveness.
For respiratory management devices and home healthcare devices, changes to software, firmware, algorithms, noise reduction mechanisms, or components can sometimes constitute significant regulatory changes. Managing changes after obtaining approval or certification is a core quality and regulatory affair for medical device companies operating globally.
Sources: MassDevice - FDA warning letter says BMC Medical brought unapproved CPAPs to US MD+DI - FDA warning over unapproved CPAP changes
Practical Implications
1. Phased Management from "First Use" to "Commercial Deployment" is Crucial for New Product Introductions
This week, we saw many news items at different stages of the product lifecycle, such as market launch, FDA clearance, commercial cases after CE Mark, first-in-human use, and first patient enrollment.
For platform products like AXELIOS 1, novel implants like Ecliptis, in-hospital systems like OPUSWAVE, and procedure-dependent devices like EndoZip and Lantern ASC, obtaining approval or clearance is merely the starting point. It is essential to design a phased approach that covers clinical introduction, physician education, case accumulation, integration into facility workflows, insurance reimbursement, and sales systems. Furthermore, products launched for research purposes, such as AXELIOS 1, may require additional regulatory compliance if they aim for future clinical application.
2. The Scope of Diseases Treated by Minimally Invasive and Non-Invasive Technologies is Expanding
The range of diseases treatable by therapies that reduce patient burden, such as StarMed's thyroid RFA, Aurenar's non-invasive neuromodulation, Nitinotes' endoscopic obesity treatment, and Reflow's retrievable scaffold, is expanding.
While being minimally or non-invasive offers significant advantages, for medical devices, it is crucial to demonstrate effectiveness, safety, procedural time, re-treatment rates, and health economics compared to existing treatments. In the U.S., there are cases where reimbursement frameworks, such as the CPT code setting for thyroid RFA, are established proactively. For the Japanese market, key discussion points will include the intended use, target patient population, positioning against existing treatments, and evaluation for insurance reimbursement.
3. Procedure Support Devices: Ease of Adoption, Not Just Accuracy, Becomes a Competitive Differentiator
Devices like OrthAlign's Lantern ASC and Terumo's OPUSWAVE assist physicians with their judgment and procedures. For such products, in addition to accuracy and image quality, factors like ease of facility adoption, operability, training burden, procedure time, and compatibility with existing equipment determine their widespread use.
Especially for products targeting U.S. ASCs (Ambulatory Surgical Centers), portability and cost structures that don't require large capital investments are crucial. In the Japanese market as well, adoption strategies tailored to hospital scale and the medical fee schedule will be necessary.
4. Change Management and Post-Market Safety: Critical Functions for Protecting Product Value
Terumo's Class I recall of stent grafts and the FDA Warning Letter to BMC Medical demonstrate how post-approval and post-market management directly impact product value. Terumo's case, in particular, showed that a malfunction in the delivery system's detachment mechanism, which is involved in the final step of a procedure, could lead to serious events, including multiple reported patient deaths.
Changes to software, firmware, algorithms, materials, delivery systems, and accessories require an assessment of their impact on safety and effectiveness. Companies operating globally are required to establish systems for change management, regulatory reporting, recall decisions, and notifications to healthcare institutions based on the regulations of each country. In the case of recalls spanning multiple countries, including Japan, aligning reporting and the scope of the recall with each country's authorities also becomes a critical issue.
5. M&A is Expanding from "Individual Products" to "Perioperative and Treatment Ecosystems"
Zimmer Biomet's acquisition of iovera is an example of orthopedic companies expanding their business scope beyond implants to include pain management and perioperative outcomes. Reimbursement policies that promote non-opioid pain management, such as the NOPAIN Act in the United States, are also contributing to the increased interest in this area.
Competition among medical device companies is shifting from focusing solely on individual product performance to providing value that encompasses pre- and post-treatment management, complication reduction, patient satisfaction, and health economics.
Summary
In the medical device and MedTech news from June 29 to July 5, 2026, we observed a significant number of developments related to new products, market launches, and first-in-human uses.
Roche's AXELIOS 1, Edwards Lifesciences' Ecliptis, StarMed's thyroid RFA, Terumo's OPUSWAVE, Nitinotes' EndoZip, OrthAlign's Lantern ASC, Peytant's AMStent, and Alafair's VersaCoat are products targeting new clinical value in diverse fields such as diagnostics, cardiovascular, minimally invasive treatment, coronary imaging, gastrointestinal endoscopy, orthopedics, respiratory stents, and surgical auxiliary materials, respectively.
On the other hand, Terumo's Class I recall of a stent graft and the FDA warning letter to BMC Medical once again highlight the importance of change management after approval, post-market safety, and quality systems.
For medical device companies, designing everything from new product development to regulatory approval, clinical evidence, physician education, insurance reimbursement, and post-market safety management as an integrated whole is crucial for competitiveness in the global market.
MK Consulting provides practical support for market entry into Japan, medical device regulatory applications, clinical evaluation,対応 with PMDA and registered certification bodies, and organization of insurance reimbursement issues. We also offer initial consultations for overseas medical device manufacturers expanding into Japan and Japanese companies expanding overseas.