Okami Medical Secures Expanded Indication for LOBO Vascular Occluder; CraniUS Therapeutics Secures Second FDA 510(k) Clearance in Six Weeks and U.S. Patent for NeuroPASS™ 3; Danaher Accelerates Life Sciences Research with New AI-Powered Autonomous Lab; Aesthetic Brokers Advises SDBotox on Strategic Partnership; BD Advances Peripheral Vascular Innovation with Positive AGILITY Trial Results; Sonorous Neurovascular Secures FDA IDE Approval for Pivotal U.S. Trial of Venous Sinus Stent in Pulsatile Tinnitus

Okami Medical Received Expanded Indication for the LOBO Vascular Occluder

On 07 October 2026, Okami Medical received an expanded FDA indication for its LOBO Vascular Occlusion System, extending the device’s application from peripheral arterial procedures to peripheral venous embolization. The expanded indication broadened the potential use of the device for treating venous conditions, including pelvic venous disease and portal hypertension. The LOBO Vascular Occluder was developed as a mechanical embolization device for controlled and reliable vessel occlusion. Its proprietary HDBRAID technology was designed to provide a high-density, small-pore structure that supported rapid blood-flow obstruction and stable placement.

The expanded venous indication strengthened Okami Medical’s position in the peripheral embolization market by increasing the range of vascular anatomies and clinical conditions that could potentially be addressed using the LOBO system. The development also represented an expansion of the company’s focus within peripheral vascular occlusion and embolization technologies.

“The LOBO Vascular Occluder represents the natural evolution of embolization devices – providing fast and predictable occlusion across a wide range of vascular conditions,” said Raj Pyne, MD, FSIR of Rochester Regional Health. “Previously in venous embolization, physicians often needed multiple redundant devices, contended with trackability issues, and faced significant CT metallic artifact that obscured follow-up imaging. LOBO’s expanded indication brings venous embolization into the next generation, providing quick and confident occlusion with precise placement while minimizing streak artifact on CT, thus simplifying procedures for physicians and follow-up for patients.”

As per DelveInsight’s “Occlusion Devices Market Report,” the global occlusion devices market size is estimated to grow at a CAGR of 6.31% during the forecast period from 2024 to 2030. The demand for occlusion devices is primarily being boosted by the increasing number of target patient populations suffering from various chronic illnesses. Furthermore, surging technological developments, rising demand for minimally invasive surgeries (MIS), suitable reimbursement scenarios for minimally invasive surgeries, and an increasing geriatric population, among others, have contributed to the overall growth of the occlusion devices market during the forecast period from 2024 to 2030.

CraniUS Therapeutics Secured Second FDA 510(k) Clearance in Six Weeks and Earns U.S. Patent for NeuroPASS™ 3 Cranial Drug Delivery System

On 07 October 2026, CraniUS Therapeutics received its second FDA 510(k) clearance within approximately six weeks for a new configuration of its patient-specific CraniUS Plate, designated NeuroPASS 2. The company also received a U.S. patent covering the integrated architecture of its investigational NeuroPASS 3 cranial drug delivery system.

The FDA clearance for NeuroPASS 2 covered a Class II patient-specific cranioplasty plate and incorporated an opening designed to accommodate an implantable intracranial pressure sensor. The device retained the core technology and indications of the previously cleared CraniUS Plate while expanding its potential functionality for future sensing applications.

Separately, the U.S. Patent and Trademark Office granted CraniUS a patent covering the architecture of NeuroPASS 3. The investigational system was being developed around a patient-specific cranial implant containing a refillable drug reservoir, regulated infusion pump, and catheters intended to deliver therapeutic fluids directly to targeted areas of the brain. The technology was designed to provide a potential approach for overcoming limitations associated with the blood-brain barrier. NeuroPASS 3 was being developed as a drug-led combination product and had not received FDA clearance or approval. CraniUS was completing its nonclinical development program and planned to progress toward a first-in-human study targeted for the second quarter of 2027.

“For more than a century, cranial reconstruction has meant one thing: close the skull and restore the bony anatomy. We founded CraniUS Therapeutics on the belief that the neuroplastic reconstruction itself can become something far more,” said Dr. Chad Gordon, Founder, Executive Chairman and Chief Medical Officer. “With a second clearance in hand and a patent protecting the much-anticipated cranial drug delivery system that comes next within a PEEK cranial plate, we are building a new interface with the brain to help patients with serious neurological conditions. We believe this is the beginning of an entirely new category within neuroplastic surgery, one that strategically uses the temporal region of the skull.”

As per DelveInsight’s “Drug Delivery Devices Market Report,” the global drug delivery devices market is expected to increase from USD 492.13 billion in 2024 to USD 760.98 billion by 2032, reflecting strong and sustained growth. The global drug delivery devices market is growing at a CAGR of 5.66% during the forecast period from 2025 to 2032. The market for drug delivery devices is being primarily driven by the increasing prevalence of chronic diseases, growing demand for self-administration and home healthcare, increased use of biologics and biosimilars, increased technological advancement, and an increase in product development activities among the key market players.

Danaher Accelerated Life Sciences Research with New AI-powered Autonomous Lab 

On 07 October 2026, Danaher Corporation announced plans to launch its first AI-powered autonomous laboratory, with operations expected to scale in early 2027. The laboratory was designed to accelerate the discovery of custom antibodies and other molecular tools by integrating artificial intelligence, robotics, automation, and technologies from multiple Danaher operating companies into a connected research workflow.

The facility was being developed at Abcam, a Danaher company, and used AI to support the creation of affinity reagents, including antibodies. Each reagent would undergo automated development and testing, with the resulting data being fed back into the AI models to improve subsequent designs. This continuous design, development, testing, and learning process was intended to shorten research cycles and improve laboratory productivity.

The autonomous laboratory brought together technologies and expertise from Beckman Coulter Life Sciences, Cytiva, Genedata, Integrated DNA Technologies, and Molecular Devices, while robotic orchestration was supported through collaboration with Automata. Danaher expected the approach to accelerate affinity-reagent discovery by up to eight times and substantially increase annual reagent generation as the laboratory scaled.

The initiative formed part of Danaher’s broader strategy to develop smart laboratory instruments, AI-ready data systems, intelligent software, and autonomous research workflows. These technologies were intended to improve laboratory integration, standardize research processes, support predictive experimentation, and allow scientists to focus more heavily on complex scientific decision-making.

“The autonomous lab reflects the kind of progress Danaher is uniquely positioned to deliver,” said Julie Sawyer Montgomery, President and Chief Executive Officer of Danaher. “By applying our science, technology and culture of continuous improvement, we can help turn promising ideas into validated systems faster. It is an important step toward a future where AI, automation and intelligent systems dramatically accelerate the journey from discovery to impact.”

As per DelveInsight’s “Lab Automation Market Report,” the global lab automation market is expected to increase from USD 9,571.12 million in 2025 to USD 22,501.13 million by 2034, reflecting strong and sustained growth. The global lab automation market is growing at a CAGR of 10.07% during the forecast period from 2026 to 2034. Labor shortages and workforce pressure, accelerated biopharmaceutical R&D, and rising demand for high-throughput diagnostics are collectively accelerating the adoption of lab automation by addressing both capacity and efficiency gaps in modern laboratories. As skilled laboratory personnel become increasingly limited and operational costs rise, automation helps reduce dependency on manual workflows while improving productivity and consistency. At the same time, rapid expansion in biopharma pipelines and complex drug discovery processes requires faster experimentation, scalable screening, and higher data accuracy, which automated systems can deliver. Similarly, the growing need for high-throughput diagnostic testing, especially in genomics, infectious disease, and personalized medicine, further drives demand for automated platforms capable of processing large sample volumes with speed and precision, ultimately strengthening overall market growth.

Aesthetic Brokers Advises SDBotox on Strategic Partnership  

On 07 October 2026, SDBotox entered into a strategic partnership following a sell-side advisory process led by Aesthetic Brokers. The transaction involved the multi-location medical aesthetics practice, although the financial terms and identity of the strategic partner were not disclosed.

Founded in 2012, SDBotox had expanded from a single location in San Diego into a 10-location medical aesthetics business operating across Southern California and Texas. Its services included injectable treatments, skin rejuvenation, laser and energy-based procedures, and other non-surgical aesthetic treatments.

Aesthetic Brokers managed the transaction process, including business valuation, market positioning, potential-buyer outreach, competitive process management, transaction strategy, and negotiations. The advisory process evaluated potential partners based on factors including clinical standards, organizational culture, leadership, growth plans, patient experience, and financial considerations. The strategic partnership provided SDBotox with additional financial backing and positioned the company to continue expanding its medical aesthetics operations and treatment capabilities. The transaction represented the fourth platform creation supported by Aesthetic Brokers since its establishment.

“A successful transaction is not about finding someone willing to buy the business,” said Bill Walker, Founder and CEO of Aesthetic Brokers. “It’s about creating real choice for the founder, understanding what makes the business truly valuable to the right buyer, and identifying a partner that can protect what was built while creating the strongest path forward.”

“Aesthetic Brokers achieved truly uncommon results in finding our optimal growth partner. The cultural and strategic alignment coupled with the deep financial backing we now possess will fuel our continued expansion and allow us to continue to be at the forefront of optimizing clinical outcomes for our patients and provide cutting-edge proven technologies for our staff. I could not be more pleased with their results,” said Dr. Alex Roher, Founder of SDBotox.

According to DelveInsight’s “Medical Aesthetic Devices Market Report”, the global medical aesthetic devices market was valued at USD 13,533.26 million in 2023, growing at a CAGR of 11.46% during the forecast period from 2024 to 2030, to reach USD 25,808.43 million by 2030. The increase in the market for medical aesthetic devices is predominantly owing to an exponential rise in the aging population and an increase in the adoption of various aesthetic procedures. Additionally, the growing awareness among the population to look aesthetically presentable and also regarding the various cosmetic procedures performed across the globe is likely to boost the market. Also, shifting preferences towards less complex, minimally invasive or non-invasive aesthetic procedures, a rise in obesity among the population, and growing technological advancement in the product arena, among others, are some of the key factors expected to raise the market for these devices during the forecast period 2024 to 2030.

BD Strengthens Leadership in Peripheral Vascular Innovation with Positive AGILITY Trial Results

On 07 October 2026, BD (Becton, Dickinson and Company) reported positive nine-month results from the iliac artery cohort of its ongoing AGILITY Investigational Device Exemption (IDE) trial, which evaluated the Revello Vascular Covered Stent in patients with peripheral artery disease and iliac artery disease. The results were presented at VIVA 2026 and provided additional clinical evidence supporting the use of covered stent technology in complex peripheral vascular disease.

The study met its primary composite safety and effectiveness endpoint, with a 2.8% failure rate, compared with the prespecified performance goal of 19%. The Revello Vascular Covered Stent achieved 97.2% primary patency and 98.3% freedom from clinically driven target lesion revascularization through nine months of follow-up. No device- or procedure-related deaths, major target-limb amputations, or unanticipated serious adverse device effects were reported during the follow-up period.

The trial enrolled 120 patients across 28 investigational sites in the United States, Europe, Australia, and New Zealand. Patients also demonstrated improvements in disease severity, daily functioning, and mobility following treatment. The Revello stent was designed to combine the flexibility of a nitinol self-expanding stent with radial resistive force suitable for iliac arteries.

BD continued follow-up of the iliac cohort through 36 months and had also completed enrollment in the study cohort evaluating the device in superficial femoral and proximal popliteal arteries. The Revello Vascular Covered Stent was CE-marked, while its use in the United States remained limited to investigational purposes.

“These latest data showed high primary patency and low clinically driven target lesion revascularization in a patient population that included both straightforward and complex iliac lesions,” said Sean Lyden, M.D., chairman of the Department of Vascular Surgery at Cleveland Clinic and global lead principal investigator for AGILITY. “Results showed the treated arteries remained open in a high percentage of patients, and at nine months, patients also showed changes in disease severity and walking ability.”

“These results reflect the continued commitment of BD to advance evidence-based innovation in peripheral vascular care,” said Rob Righi, vice president and general manager of the Vascular Platform, Peripheral Intervention at BD. “As follow-up continues, the AGILITY study will help further characterize the Revello™ Vascular Covered Stent’s performance across patients with peripheral artery disease.”

As per DelveInsight’s “Vascular Stents Market Report” the global vascular stents market was valued at USD 11,232.93 million in 2024, growing at a CAGR of 6.35% during the forecast period from 2025 to 2032 to reach USD 18,277.68 million by 2032. The overall market for vascular stents is being significantly boosted by the rising cases of cardiovascular disorders and associated risk factors such as diabetes, hypertension, and obesity, which are driving the need for effective vascular interventions. Growing awareness about cardiovascular health and the expansion of screening programs are enabling early detection and treatment of arterial blockages, thereby increasing the adoption of stenting procedures. Additionally, the rising number of angioplasty procedures worldwide is directly fueling the demand for vascular stents, as they play a crucial role in restoring blood flow. Furthermore, continuous product development and innovation by key market players are enhancing clinical outcomes and expanding the use of stents across a wider patient base, collectively accelerating the growth of the vascular stents market during the forecast period from 2025 to 2032.

Sonorous Neurovascular Received FDA IDE Approval for First U.S. Pivotal Trial of a Venous Sinus Stent to Treat Pulsatile Tinnitus 

On 07 October 2026, Sonorous Neurovascular received FDA Investigational Device Exemption (IDE) approval on October 2, 2026, allowing the company to initiate its U.S. pivotal B-SILENT 2 clinical trial evaluating the BosSTENT cerebral venous stent for patients with pulsatile tinnitus associated with venous sinus stenosis. The trial represented the first FDA-approved U.S. pivotal study evaluating a venous sinus stent specifically for this indication.

The BosSTENT was a braided, self-expanding stent developed for use in the cerebral venous sinuses. The company planned to begin patient enrollment in the United States during the fourth quarter of 2026. The FDA milestone followed the device’s Breakthrough Device Designation in February 2026 and the company’s 510(k) clearance for its BosCATH neurovascular support catheter in April 2026.

The development strengthened Sonorous Neurovascular’s clinical development program for cerebral venous disease and supported the advancement of purpose-built venous sinus stenting technologies for pulsatile tinnitus. The company was also conducting its international B-SILENT study in France and Canada to generate clinical evidence supporting future European regulatory submission.

“FDA IDE approval represents a major milestone for Sonorous and for our mission to establish a purpose-built treatment for patients suffering from debilitating pulsatile tinnitus caused by venous sinus stenosis,” said Joel M. Harris, Chief Executive Officer of Sonorous Neurovascular. “Together with our international B-SILENT program, B-SILENT 2 gives us a clear clinical pathway to generate the evidence needed to bring BosSTENT™ to patients in the United States and other major markets. BosSTENT™ was designed specifically for cerebral venous anatomy, and this milestone further advances our strategy of building a comprehensive platform for cerebral venous disease.”

“Pulsatile tinnitus can be profoundly disabling, and our patients deserve treatment decisions based on rigorous evidence rather than extrapolation from devices and indications developed for other conditions,” said Emanuele Orru, MD, of Lahey Hospital & Medical Center, Co-Principal Investigator of B-SILENT 2. “This study is an important opportunity to evaluate a device designed specifically for the venous sinus and to establish a more rigorous framework for patient selection and treatment of venous pulsatile tinnitus.”

According to DelveInsight’s “Intracranial Stents Market Report,” the global intracranial stents market is poised for significant growth, projected to achieve a remarkable Compound Annual Growth Rate (CAGR) of 6.75% during the forecast period from 2024 to 2030. The demand for Intracranial Stents is primarily being boosted by the rising prevalence of neurological disorders such as intracranial stenosis and brain aneurysm. Additionally, the increasing prevalence of ischemic stroke and transient ischemic attack (TIA), and increasing technological advancements leading to more product development and launches, are some of the key factors contributing to the growth of the Intracranial Stents market during the forecast period from 2024 to 2030.