Hotline 24/7: 0909384389

Share links:

Centerline Biomedical’s surgical positioning system gets FDA clearance

Ngày 17/07/2019 07:20 | Lượt xem: 1748

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Centerline Biomedical’s Intra-Operative Positioning System (IOPS), a device used in endovascular procedures to provide 3D visualisation.

The non-radiation-based surgical navigation system uses anatomical mapping algorithms and electromagnetic tracking to give surgeons 3D colour visualisation and guidance during procedures.

The holographic system, developed at Cleveland Clinic’s Heart and Vascular Institute (Cleveland, USA), offers an alternative to the current standard of care, X-ray fluoroscopy, which exposes surgeons and operating room staff to potentially dangerous radiation.

“Having worked closely with Centerline for almost five years, I am very pleased to see that IOPS will soon be commercially available,” remarks Matthew Eagleton, chief of Vascular Surgery at Massachusetts General Hospital (Boston, USA) and chair of the company’s scientific advisory board. “We hope to use this game-changing technology to revolutionise our approach to vascular procedures and imaging.”

This milestone, achieved working with regulatory partner JALEX Medical, will allow marketing and commercial use of IOPS for endovascular interventions in the descending aorta, though the underlying platform will be applicable to many other minimally invasive procedures in the future, a press release states. Such future indications may include structural heart interventions, an application the company is currently exploring with funding from an NIH small business grant. The company’s research and development efforts will continue in parallel with Centerline’s upcoming market launch.

Source VascularNews

Duc Tin Clinic

Tin tức liên quan

Vesteck completes first-in-human use of several Suture-Tight devices

Age is just a number: Individual patient data meta-analysis probes safety of CEA in the elderly

Artificial intelligence can predict risk of complications after endovascular aneurysm repair

Bluegrass Vascular announces Journal of Vascular Surgery paper reporting use of Surfacer system

Vascular access creation: EndoAVF keeps future options open, but is not a replacement for surgical fistulas

SUPPORT CONSULTANT

CUSTOMER REVIEWS

• I am Nguyen Thanh Sang, born in 1990. Since the examination and treatment at the clinic Duc Tin, I am very grateful to the Doctor for explaining and sharing about my illness. During the treatment time in the clinic I was very caring staff of the clinic. Now my illness has improved in a good way. Expect more and more clinic to be able to save many patients.

  I sincerely thank you !. Tel: 0938303275

• Huynh Thi Muoi, born in 1940, was examined and treated at Duc Tin Clinic. I am very pleased about how to serve and care patients of the clinic. The doctor is committed to explaining and sharing with the patient.

  Huynh Thi Muoi sincerely thank you! Phone number: 0972868746

• As I said Duc Tin surgical clinin is where my family trust, hope to visit. Physicians caring, thoughtful, gentle to the patient. Nurses and staff clinic polite, cheerful and thoughtful. This clinic clean, sterile, so I would love to. Tel: +84949914060.

• The doctor is very caring, attentive and very gentle nurse, courteous, affable with me. The clinic is clean, comfortable, polite. I enjoyed this faith. Every visit I was very relieved disease. Tel: 0839820792.

• I was patient, had to clinics of Dr. Le Duc Tin. I see very conscientious doctor patient care, answer any questions and very dedicated staff from the receptionist to the children tested, nursing. Clinics very clean and spacious. I'm very satisfied. Tel: +841227880829.

Search

News

Customer support