Correction (October 18, 2026): Relevant facts and wording have been corrected against primary sources and the original text. Transaction and product status refer to the original reporting period.
Global Medical Device News: J&J Surgical Robot, Fujifilm MRI, New Developments in Vision Restoration BCI
Period: July 20-26, 2026
From July 20-26, 2026, global medical device and MedTech news saw a series of new product approvals, market launches, and funding rounds in areas such as surgical assistance robots, diagnostic imaging equipment, vision restoration devices, wearable blood pressure monitoring, diabetes devices, and intravascular robots.
Regarding Japan-related news, Fujifilm launched a new open MRI model equipped with AI-powered image reconstruction capabilities. Additionally, the Ministry of Health, Labour and Welfare's Central Social Insurance Medical Council (Chuikyo) discussed the health insurance coverage of medical devices and clinical tests.
Main News
1. Johnson & Johnson Wins FDA De Novo Authorization for Ottava Surgical Robot
Johnson & Johnson has received FDA De Novo authorization for its Ottava Surgical Robotic System, designed for soft tissue surgery.
Ottava features a design that integrates robotic arms into the operating table, allowing the arms to be stored underneath the table when not in use. The company plans to gradually introduce the system in select U.S. healthcare facilities and intends to expand the scope of procedures and sales regions in the future.
Sources: MassDevice: Johnson & Johnson wins FDA nod for Ottava surgical robot Johnson & Johnson: OTTAVA Robotic Surgical System FDA Market Authorization
2. Momentis Surgical Receives FDA Clearance for Anovo Surgical Robot's Multiport Configuration
Momentis Surgical has obtained FDA 510(k) clearance for the multiport configuration of its "Anovo Surgical System," which features flexible robotic arms.
Anovo had already received approval for transvaginal and single-port surgeries, and with this latest addition, it now supports three types of approaches: transvaginal, single-port, and multiport. This development expands the options for minimally invasive surgical robots, particularly in the field of gynecology.
Source: MassDevice: FDA clears Momentis Surgical’s multiport surgical robot
3. Fujifilm Launches New Open MRI Models Utilizing AI Technology
Fujifilm launched new models of its permanent magnet open MRI systems, "APERTO Lucent ff" and "AIRIS Vento ff," on July 21, 2026.
The new models aim to reduce noise and enhance image quality even in low-field MRI, through image reconstruction technology developed utilizing AI. The lineup includes the 0.4 Tesla "APERTO Lucent ff" and the 0.3 Tesla "AIRIS Vento ff," both equipped with functions that support the MRI examination workflow, such as imaging position settings and image processing.
This is noteworthy news regarding a new diagnostic imaging device product in the Japanese market.
4. Science Corporation Launches "Prima" Vision-Restoring BCI in Europe
Science Corporation has commercially launched "Prima," a vision-restoring system utilizing a subretinal implant, in Europe.
Prima is a system that assists in restoring central vision for patients with age-related macular degeneration accompanied by geographic atrophy. It works by transmitting images captured by a camera mounted on eyeglasses to a subretinal implant. The rollout will be phased across France, Germany, Italy, the Netherlands, and the United Kingdom.
Source: MassDevice: Science Corp. launches Prima vision-restoring BCI in Europe
5. Hilo Launches "Hilo Core" Wearable for Long-Term Blood Pressure Monitoring in the US
Hilo has launched "Hilo Core," a wrist-worn blood pressure monitoring system, in the United States.
Hilo Core consists of a band equipped with optical sensors, a smartphone app, and an FDA-cleared cuff-based blood pressure monitor. While undergoing regular calibration with the cuff, it estimates blood pressure trends approximately 30-35 times a day.
Traditionally, blood pressure measurement has primarily relied on cuff-based methods, but wearabilization may make it easier to understand blood pressure fluctuations during daily life.
Source: MassDevice: Hilo launches wearable blood pressure monitoring tech
6. Philips Receives FDA Clearance for Reusable SpO₂ Clip Sensor
Philips has obtained FDA 510(k) clearance for its next-generation reusable SpO₂ clip sensor.
The new product is a sensor designed for continuous measurement of oxygen saturation and pulse rate in adult and pediatric patients. By making it reusable, Philips aims to reduce waste from disposable sensors and lower operational costs.
Source: MassDevice: Philips gets FDA nod for next-gen pulse oximetry clip sensor
7. Diabetes Devices: Medtrum Advances 300U Patch Pump Toward German Launch; MiniMed Flex Becomes Available to Medicare Beneficiaries
Medtrum announced the introduction of its tubeless patch pump, "TouchCare Nano," which can hold 300 units of insulin, to the German market.
Additionally, MiniMed announced that its "Flex Insulin Pump" is now available to Medicare and Medicare Advantage beneficiaries in the United States. The Flex is an automated insulin delivery system that integrates with the Simplera Sync CGM.
In the diabetes sector, the ecosystem competition continues, encompassing CGM, pumps, apps, and insurance reimbursement.
Sources: MassDevice: Medtrum to bring 300U tubeless insulin patch pump to Germany MassDevice: MiniMed says Flex insulin pump is now available through Medicare
8. Lungpacer Receives New CPT Codes for AeroPace Diaphragmatic Nerve Stimulation System
Lungpacer Medical announced that its "AeroPace System," which assists in weaning patients from mechanical ventilation, has been assigned three new CPT Category III codes.
AeroPace is a system designed to stimulate the phrenic nerve via a catheter to mitigate diaphragmatic dysfunction during mechanical ventilation. Three Category III CPT codes became effective on July 1, 2026.
Source: MassDevice: Lungpacer picks up reimbursement win for AeroPace
9. Magnendo Raises $18 Million for Magnetic Intravascular Robot Development
Magnendo, an MIT spin-out, has raised $18 million in Series A funding to advance the development of its magnetic navigation technology for endovascular procedures.
Penumbra led this funding round. Magnendo is developing a robotic platform that uses magnetism to remotely control neurovascular devices.
Source: MassDevice: Magnendo raises $18M Series A
10. MannKind Secures FDA Approval for Furoscix Auto-Injector, Raises $50 Million
MannKind has received FDA approval for its Furoscix ReadyFlow Auto-Injector, a subcutaneous furosemide product for heart failure patients.
Concurrently, the company announced a private placement for $50 million in financing. Furoscix is designed to allow patients to administer furosemide subcutaneously at home, as an alternative to intravenous administration in a healthcare setting.
Source: MassDevice：MannKind raises $50M, wins FDA nod for Furoscix auto-injector
11. Central Social Insurance Medical Council Discusses Insurance Coverage for Medical Devices and Clinical Tests
At its general meeting on July 22, 2026, the Central Social Insurance Medical Council (Chuikyo) of the Ministry of Health, Labour and Welfare raised the topic of "Insurance Coverage for Medical Devices and Clinical Tests."
For medical devices, insurance coverage after regulatory approval and their positioning in medical fees significantly impact market introduction. In domestic medical device news, information related to insurance coverage discussions at Chuikyo is as important as new products and approvals.
Source: Ministry of Health, Labour and Welfare: Central Social Insurance Medical Council General Meeting
12. FDA Issues Early Warning for Boston Scientific's EnRoute Catheter
The FDA has issued an early warning regarding certain lots of Boston Scientific's "EnRoute Neuroprotection System" and "EnRoute Neuroprotection System Plus."
The company is recommending that affected products be discontinued and removed due to reports of complete or partial separation of the arterial sheath tip. The EnRoute system is designed to reverse blood flow during carotid artery stenting to prevent emboli from reaching the brain.
That same week, the FDA also updated early warning information regarding a shortage of breast biopsy needles, an expanded recall of reprocessed electrophysiology and ultrasound catheters, and Abiomed and Oscor catheter introducers.
Source: FDA: CDRH New－News and Updates
Summary
In medical device and MedTech news from July 20-26, 2026, the surgical robot market saw increased competition with Johnson & Johnson's Ottava and Momentis Surgical's Anovo successively receiving FDA approval.
Regarding Japan-related news, Fujifilm launched a new open MRI model equipped with AI-powered image reconstruction capabilities. Additionally, the Central Social Insurance Medical Council (Chuikyo) discussed the insurance coverage of medical devices and clinical tests, confirming trends in domestic market reimbursement.
Overseas, new products continued to launch and gain approval, including the visual reconstruction BCI "Prima," the wearable blood pressure monitoring system "Hilo Core," and Philips' reusable SpO₂ sensor. In the diabetes sector, Medtrum announced the European expansion of its high-capacity patch pump, and MiniMed Flex was announced to be covered by Medicare.
In fundraising, Magnendo raised $18 million for the development of magnetic intravascular robots. Meanwhile, regarding safety, the FDA issued an early warning about Boston Scientific's EnRoute catheter system.
This week saw a wide range of developments both domestically and internationally, covering surgical robots, diagnostic imaging, visual reconstruction, wearables, diabetes devices, reimbursement, and safety information.