MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Home » Spirus wins Japanese regulatory approval for Endo-Ease line

Spirus wins Japanese regulatory approval for Endo-Ease line

By

Spirus logo

Spirus Medical Inc. received regulatory approval for its Endo-Ease product line from the Japanese Ministry of Health, Labor and Welfare.

The Stoughton, Mass.-based company’s endoscopy platform features novel “over-tubes” that use a spiral design utilizing simple rotation to facilitate enteroscopy, colonoscopy and ileoscopy, according to the company.

The Endo-Ease "endoluminal advancement system" is well suited for the Japanese endoscopy marketplace, which emphasizes in-hospital treatment, according to Spirus.

"We anticipate that the clinical benefits of the Endo-Ease will prove to be highly appealing to health care providers and their patients throughout Japan,” COO Robert Ailinger said in prepared remarks. The platform has several gastroenterology applications and additional treatments in development in other markets, according to the company.

Tokyo-based medical device supplier Century Medical Inc. will sell and market the products in Japan for Spirus.

In case you missed it

RSS From Medical Design & Outsourcing

  • Pfizer wins FDA nod to store COVID vaccine at normal freezer temps
    The FDA announced today that it is allowing undiluted, frozen vials of the Pfizer-BioNTech COVID-19 vaccine to be transported and stored for up to two weeks at conventional temperatures commonly found in pharmaceutical freezers. The decision should allow for wider distribution of the vaccine to sites that do not have ultra-low temperature freezers. Pfizer asked… […]
  • 8 drug delivery innovations you need to know
    The drug delivery space has seen plenty of innovation over the years and there are no signs of that slowing down any time soon. Improvements upon established technologies like insulin delivery devices and inhalers have been presented by some, while others have unlocked new ways of delivering drugs through a variety of means. Among the… […]
  • Hoffer Plastics gains MedAccred certification again
    Injection molding company Hoffer Plastics (South Elgin, Ill.) announced that it has received the MedAccred re-certification from not-for-profit medtech audit provider MedAccred. MedAccred is a supply-chain oversight program of the Performance Review Institute. It conducts critical-process audits for its member OEMs to ensure their suppliers adhere to global regulations and requirements, and helps reduce the number… […]
  • UK passes post-Brexit medical device regulation
    The U.K. has enacted a new law governing medical devices and drugs, with a focus on patient safety. The Medicines and Medical Devices Act, introduced in July 2020, establishes the position of commissioner for patient safety to respond to public and patient complaints and concerns about drugs and medical devices. The law was necessitated by… […]
  • Integrated Polymer Solutions acquires IRP Group
    Integrated Polymer Solutions (“IPS”), a portfolio company of Arcline Investment Management, announced this week that it has acquired IRP Group. IRP designs and manufacturers elastomeric sealing components from its facilities in Southern California. Founded in 1999, the company is focused on the Class I and II medical device market as well as the aerospace &… […]
  • Interpower debuts plugs in new colors
    Interpower announced that its NEMA 5-20 hospital-grade plugs for use in North America now come in molded colors of clear, black or gray on 10-foot lengths of flexible cord. These molded plugs complement the company’s NEMA 5-20 hand-wired hospital-grade plugs. The North American 18A hospital-grade power cord on 14 AWG SJT cable and North American… […]
  • Portescap motors gain certification
    Portescap announced that its slotless brushless DC motors for respirators have received ISO 13485:2016 certification. Expanding on ISO 9001, this standard contains specific requirements for parts traceability and risk management activities throughout the design and development stages. It also requires process and software validations at defined intervals. Independent risk management and quality compliance firm DNV… […]
  • Instron launches update to product testing system
    Materials testing equipment and software developer Instron announced the launch of the Torsion Add-On 3.0 for universal testing systems. Recently redesigned to take advantage of the latest functionality offered by the new Instron 6800 series, this system offers a simpler, safer, and more intuitive user experience, according to Norwood, Mass.-based Instron. Instron introduced the Torsion… […]
  • Abiomed CEO Michael Minogue appointed as AdvaMed chairperson
    Medtech trade group AdvaMed today said it has appointed Abiomed (NSDQ:ABMD) president and CEO Michael Minogue as chairperson of the AdvaMed board of directors, effective immediately. Minogue will serve as chairperson of the trade association’s board of directors for two years. He has been a member of the board since 2007 and a member of the board… […]
  • Credit card-sized pump could enable ‘power clothing’ to help patients with mobility
    Robotic clothing that is entirely soft and could help people to move more easily is a step closer to reality thanks to the development of a new flexible and lightweight power system for soft robotics. The discovery by a team at the University of Bristol (UK) could pave the way for wearable assist devices for… […]
  • ACSYS Lasertechnik debuts quick-change laser system
    ACSYS Lasertechnik (Lenexa, Kan.) recently announced the development of its patent-pending, ultra-short pulse,  quick-change laser system for marking, engraving and cutting for medical device applications. The system uses a galvanometer scanner equipped with either f-theta marking optics or a laser cutting head to provide interchangeable flexibility and precision. When in marking mode, the system can… […]

Leave a Reply