SAEUM MEDITEC CO., LTD. of Bucheon-si, Gyeonggi-do at MEDICA 2018 in Düsseldorf -- MEDICA - World Forum for Medicine


#102-1406, 36, Bucheon-ro 198beon-gil, Wonmi-gu, 14557 Bucheon-si, Gyeonggi-do
Korea, Republic
Telephone +82 32 6610804
Fax +82 32 6610805

This company is co-exhibitor of
Korea Medical Devices Industrial Coop. Association (KMDICA)

Hall map

MEDICA 2018 hall map (Hall 7a): stand C09

Fairground map

MEDICA 2018 fairground map: Hall 7a


Alicia Song



Cielo Kim



Our range of products

Product categories

  • 01  Electromedical Equipment / Medical Technology
  • 01.03  Surgery devices, endoscopy devices
  • 01.03.08  Neurosurgical instruments and equipment

Our products

Product category: Neurosurgical instruments and equipment

EPI-Detection® is Medical pressure monitor to detect the epidural space

SAEUM MEDITEC was established in 2015 and HQ and manufacturing facility are in Bucheon city.
We are the RND ORIENTED company and will continue to cooperate with the hospitals. We will do our best to research the technology which is practically needed for the practitioners and will commercialize a good idea into the medical device.
After achieving EPI-DETECTION® patent in Korea, certified ISO13485:2003 in dec, 2016. Then GMP in May 2017, March 2018  MDD CE (Class ll-a) certified. After that, we applied patent in EU, CN, JP, AU and INDONESIA. END OF THIS YEAR, WE LOOK FORWARD WORKING FOR 510(K) in 2018. 

The EPI-Detection® is Medical pressure monitor and use it to detect the epidural space for accuracy of procedure of “Epidural block”
When the Epidural needle reaches the epidural space, it detects the pressure change of the muscle layer and epidural space. the pressure sensor recognizes it, and then displayed on LED so that the user can identify it.
It has a structural feature that allows the Racz’s catheter to be inserted right away.
To put it simply, the device supports the safe treatment of patient by allowing the Epidural needle to precisely reach the epidural space.

This product was developed in collaboration with Severance Hospital, and so far clinical research has been actively carried out. According to the study 100 cases (EPI-Detection ver.1) in 2016, epi- detection was approved its effectiveness and stability. With this result, In July, 2017, we obtained a KOTRAN FDA approval for a medical pressure gauge.

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Company news




Oct 5, 2018

EPI-DETECTION, an Innovative Automatic Pressure Monitor for Epidural Injections

Saeum Meditec, a Korean firm, recently acquired European CE Mark approval for its EPI-DETECTION device, a novel digital pressure monitor with original technology developed by the company with help from Severance Hospital, Yonsei University.


“In the field of medical devices, we were able to create something new from an existing concept based on our R&D oriented identity and we devote ourselves to product development with the intention of switching ideas,” said Sangwon Yoon, CEO of Saeum. “Our mission is, ‘We strive to deliver practical medical devices by IT convergence engineering for safer and more effective procedures to improve healthcare outcomes for all.'”

Applications (Anesthesia & OB/GYN):

Epidural Steroid Injections (cervical, lumbar, thoracic epidural)
Labor Epidural for Cesarean Section
The utilization of health care services for chronic low back pain has increased substantially over the past two decades. (Source: Freburger, Janet K. et al. “The Rising Prevalence of Chronic Low Back Pain.” Archives of Internal Medicine 169.3 (2009): 251–258. PMC. Web. 17 Aug. 2018.)

Overall epidural injections increased 99% per 100,000 Medicare beneficiaries (2000-2014) and 2.25 million in 2014 (45%). (Source : Laxmaiah Manchikanti et al. BMJ Open 2016;6:e013042)

For treatment of back pain, 95% of people look for interventional management. Depending on the type of back pain you have, your doctor might recommend medications. Over-the-counter (OTC) pain relievers maybe some of them. If other measures don’t relieve your pain, and if your pain radiates down your leg, your doctor may inject cortisone, an anti-inflammatory medication, or numbing medication, into the space around your spinal cord (epidural space). A cortisone injection helps decrease inflammation around the nerve roots, but the pain relief usually lasts less than a few months.

  • For epidural injection, most commonly used methods is Loss of Resistance technique using saline (LOR) and it depends on the anesthesiologist’s or surgeon’s skill level in placing ESI (Epidural Steroid Injection). Furthermore, it is very difficult in patients who are obese or have abnormal vertebral anatomy.
  • To solve significant unmet needs, the EPI-Detectio was invented to detect the epidural space for accuracy of ESI. When the epidural needle reaches the epidural space, it detects the pressure change of the muscle layer and epidural space. The pressure sensor recognizes this, which is displayed on an LED so that the user can easily identify it.
  • It has a structural feature that allows the Racz’s catheter to be inserted right away. To put it simply, the device supports the safe treatment of patients by allowing the epidural needle to precisely reach the epidural space.
  • In Korea, the total number of procedures for neuroprotection is estimated to be about 25 million by 2017. Epidural block is 20% and Caudal block is 30%. Neuroplasty is performed about 150,000 every year.

EPI Detection, created with the advice of Severance Hospital medical staff, helps to perform ESI quickly and accurately. The disadvantage of the resistance dissipation method, which has been widely used in the past, has been revolutionized, and the digital sensor recognizes the pressure change and informs the exact location of the epidural space.

The pressure changes in the body-specific area are measured with a digital sensor and displayed by the LED as green (ready) and blue (detection) so that the operator can identify the puncture needle to reach the exact position of the epidural space.

Yoon Sangwon, CEO of Saeum Meditec, said, “Koreans use chopsticks everyday at the kitchen table. Their finger culture may be superior to people in many foreign countries. Because the traditional method is very dependent on the sense of the practitioner (tactile feedback at the finger tips), it is of great help to young doctors all over the world.”

Clinical trials of the device are currently underway. Efficiency and stability have been verified since 2016 and the current study, which initiated in January 2018, uses Epi Detection in 70 cases to verify how the  procedure time is shortened and how many times the use of C-Arm and radioactivity is reduced. Results are expected to be announced soon.

“We plan to show off our technology by participating in MEDICA in Dusseldorf, Germany (booth location : Hall 7a / C09 ) “We will also expand our product line-up gradually in the future by 2022,” he added.

“We are an R & D based company. I will continue to do my best in the process of researching the technology that medical practitioners actually need and making this idea into a medical device. ”

Here’s a video introducing the EPI-Detection device:

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Jul 27, 2018

국산 경막외 신경성형술 ‘디지털 압력계’ 잠재력 무한

[의학신문·일간보사=오인규 기자] "의료기기 분야에서 기존에 있는 개념을 바꾸고 새로운 것을 만들며, 발상의 전환을 하자는 마음으로 제품 개발에 몰두했고 성과를 냈습니다. 국내 기술로 개발한 경막외 신경성형술 '디지털 의료용 압력계' 주목하셔도 좋습니다"

세움메디텍 '에피 디텍션' 제품 이미지
새움메디텍 '에피 디텍션' 제품 이미지새움메디텍(대표 윤상원)은 최근 자사 원천기술로 개발한 디지털 압력계 `에피 디텍션(EPI DETECTION)`에 대한 우수한 기술력과 높은 잠재력을 인정받아 유럽 CE 허가를 취득하고 글로벌 시장 공략에 박차를 가하고 있다고 25일 밝혔다.

국내에서 신경차단술의 총 시술건수는 2017년 기준 약 2,500만건으로 알려졌다. 이중 Epidural Block은 20%, Caudal Block은 30%가 시술되고 있다. 또한 신경성형술은 매년 약 15만건이 시행된다.

세브란스병원 의료진의 자문을 얻어 제작한 에피 디텍션은 신경성형술을 빠르고 정확하게 시술할 수 있도록 지원한다. 기존에 널리 활용됐던 저항소실법의 단점을 혁신적으로 개선, 디지털 센서가 압력 변화를 인지해 경막외공간의 정확한 위치를 알려주기 때문이다.

인체 특정 부위의 압력 변화를 디지털 센서로 측정, 시술자가 식별 가능하도록 LED로 녹색(준비)·파란색(탐지)으로 표시해 천자바늘이 경막외공간의 정확한 위치에 도달하도록 도와준다.

저항소실법으로 시술하기 힘들고 황색인대가 정중부에서 닫혀있지 않은 환자, 노인 또는 선천적으로 극돌간인대의 변성에 의한 공동형성의 결과로 틈이 생긴 경우에도 압력 변화에 대한 변동 값을 검출 하므로 정확한 경막외공간 검출이 가능케 한다.

윤상원 대표는 "시장성에 대한 충분한 고려가 이뤄진 가운데 손가락 문화가 약한 해외에서 호평을 받고 있다"라며 "전통적인 방법이 시술자의 감각에 매우 의존할 수밖에 없다는 점에서 상대적으로 케이스가 적은 개원가를 비롯해 경험을 쌓아나가는 젊은 의사들에게 큰 도움이 된다"고 설명했다.

임상도 활발하게 진행 중인 상태다. 2016년부터 효용성 및 안정성을 검증했는데 현재 2018년 1월부터 진행되는 연구는 70케이스를 가지고 에피 디텍션을 사용함으로써, 어떻게 시술시간이 단축되며 Carm의 사용횟수 및 방사능 피폭량이 줄어드는지 검증하고 있고 분석 결과가 조만간 발표될 예정이다.

"의료진들의 실제로 원하는 아이디어, 제품화 최선"

한편 CE 인증을 시작으로 새움메디텍은 9월 첫 수출 그리고 올해 말을 목표로 에피 디텍션에 대한 미국 특허 및 FDA 준비도 차근차근 계획하고 있는 단계다.

윤 대표는 "국내외 각종 학회를 비롯해 올해 독일 뒤셀도르프 국제 의료기기 전시회(메디카)에도 참여해 우리의 기술을 뽐낼 계획"이라며 "또한 2022년까지 향후 점층적으로 제품 라인업을 확대할 예정이다"라고 덧붙였다.

그는 "우리는 R&D를 기반으로 하는 기업이다. 지속적으로 의료진들이 실제로 필요로 하는 기술을 연구하고, 이 아이디어를 의료기기로 제품화 하는 과정에 최선을 다할 것"이라고 포부를 밝혔다.

의학신문 의학신문 오인규 기자

출처 :

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About us

Company details

* Saeum Meditec AT A GLANCE

§Founded in 2015
§Headquarter: Bucheon, Korea
     Bucheon Chunui Techno Park tower #102-14F 
§Manufacture : Bucheon, Korea
     Bucheon Chunui Techno Park tower  #102-15F 
§10 Employees

** Mission statement
We strive to deliver practical medical devices by IT convergence engineering for safer and more effective procedures
to improve healthcare outcomes for all.

*** History
Dec       FDA : 510(k) on the way #880-2500, 888-2740
Dec       EN ISO 13485:2016 certificate expected     
June   Patent applied in Australia
May   Patent applied in Japan, Europe
April   Patent applied in China
March    MEDICAL CE certificated [No. IT279657, Bureau Veritas]
March     EN ISO 13485:2012 certificated [No. IT279656, Bureau Veritas]

Dec       EPI-Detection trade mark [No. 4020170167429]
Sep      「A poly catheter vibrator clip device for preventing and blocking the production   of biofilm 」   Patent [No. 10-2017-0109392]
May     GMP certified [No. KTC-AAB-170223]
Feb     「 Epidural space cognitive detection device 」 PCT  [PCT/KR2017/001451] 
Dec     ISO 13485:2003 certificated[No. 16-B-0137 IGC]
Dec     ISO 9001:2008 certificated[No. 16-A-0213 IGC]
July    Patent in Korea  [No.10-1639641]

Dec     Medical device manufacturing license approved
Aug     Saeum Meditec founded

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Area of business
  • Electromedical equipment / Medical Technology
  • Medical Services and Publications