Olympus completes acquisition of GI stent maker Taewoong Medical

The Taewoong Medical Niti-S hot Spaxus stent. [Image courtesy of Olympus/Taewoong Medical]Olympus announced today that it closed its acquisition of Taewoong Medical, a Korea-based medical device manufacturer.

Taewoong Medical develops gastrointestinal (GI) metallic stents, among other offerings. Olympus announced its intent to acquire the company for $370 million in February 2023. The deal includes $255.5 million upfront, with up to $114.5 million in potential milestone payments over a two-year period.

Olympus says Taewoong, which joins the company as a subsidiary, helps to strengthen its GI EndoTherapy product portfolio. The company offers stents designed for biliary tract, esophagus, colon and duodenum treatments. It joins the Olympus Therapeutic Solutions division.

“Taewoong and Olympus share a passion for supporting patients suffering from GI diseases, and the completion of the acquisition is a vital milestone in our commitment to provide a full portfol…

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Olympus, Canon Medical partner on endoscopic ultrasound

Canon Medical and Olympus announced that they reached an agreement to collaborate on endoscopic ultrasound technology.

Under the agreement, Canon will develop and manufacture diagnostic ultrasound used in endoscopic ultrasonography (EUS). Olympus handles the sales and marketing efforts in the collaboration.

The deal utilizes Canon’s Aplio i800 diagnostic EUS ultrasound and Olympus’ ultrasound endoscope. Canon and Olympus aim to provide the market with advanced EUS equipment for high-quality image diagnoses. The companies plan to focus on technological advancements and enhancing diagnostic performance. They plan to work together on global expansion, beginning in Japan and Europe.

According to a news release, Canon’s strengths lie in its advanced ultrasound image quality and proprietary technologies. Olympus offers early detection, diagnosis, staging and minimally invasive treatments. The companies hope the collaboration provides qualitat…

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Olympus bronchoscopes in Class I recall could lead to burns, fire

The FDA labeled a recall of Olympus bronchoscopes that could lead to burns or fire Class I, the most serious kind.

Olympus reports 192 complaints related to the issue, including four injuries. The company has received no reports of death.

This recall — a correction, not a product removal — applies to Olympus bronchofiberscopes and bronchovideoscopes. The company distributed affected devices between Jan. 1, 2001, and Sept. 11, 2023 before initiating the recall on Oct. 12. In total, the recall affects 17,691 devices in the U.S.

Olympus scopes in the recall work with accessories and cameras and lights to examine or treat a person’s airways. Olympus recalled certain scopes because they may lead to burns or catch fire.

Using affected scopes could cause serious health consequences, including critical burns in a person’s airways or lungs. It could also lead to airway bleeding, trouble breathing, apnea, loss of consciousness or death. Combusti…

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Sony, Olympus to collab on next-gen endoscopes

Olympus announced today that it agreed to a new business alliance with Sony over medical devices — specifically endoscopes.

The two companies first entered into a collaboration in September 2012, establishing Sony Olympus Medical Solutions. The joint venture aimed to combine Olympus’ lens and optical technologies, plus brand and R&D, with Sony’s broad range of technologies. That includes Sony’s digital imaging solutions.

Together, the companies aimed to create new products and business that “contribute to the development of the healthcare system.” They managed to develop three products so far and now seek to strengthen their agreement to further expand the collaboration.

Olympus said the scope of the 2012 agreement covers surgical endoscopes with 4k (or higher) resolution or 3D function. The companies now aim to expand to next-generation gastrointestinal and respiratory endoscopes. In particular, they hope to strengthen …

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Olympus has more warnings over bronchoscopes

Olympus has initiated a voluntary field corrective action following reports of endobronchial combustion incidents involving bronchoscopes.

The field corrective action — announced Nov. 9 — is taking place after incidents occurred during medical procedures utilizing high-frequency therapy equipment in environments rich in oxygen, according to the company.

The warnings are separate from Olympus’ July field corrective action involving laser-compatible bronchoscopes tied to reports of endobronchial combustion, serious patient injury, and one death.

The new round of bronchoscope warnings came after Olympus received complaints about adverse events, some resulting in serious patient injuries. Endobronchial combustion could result in burns to the airway or lungs, necessitating additional medical intervention, prolonged procedures, extended hospital stays, intensive care, and in some cases, fatalities.

Health providers use the bronchoscope in endoscop…

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Olympus warns on insufflation unit after reported death, other complications

Olympus announced a field corrective action in the U.S. due to over-insufflation during use of its UHI-4 high-flow insufflation unit.

The company designed UHI-4 to facilitate laparoscopic and endoscopic observation, diagnosis and treatment. It insufflates the abdominal cavity and colon, providing automatic suction and smoke evacuation.

Olympus received complaints of patients suffering complications from over-insufflation with the device. That included arrhythmias reported as “short cardiac arrests,” and gas embolism.

The company received one report of death during a surgical procedure that used UHI-4 devices.

Olympus requested in an Oct. 25 corrective action letter that customers discontinue use of the device until further notice. Customers who don’t have an alternative available or who are unable to obtain one may use the device. Olympus said it issued this direction because it considers safety and risk mitigation as “top …

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Olympus launches operating room visualization, integration system

The EasySuite ES-IP system in use in the OR. [Image courtesy of Olympus]Olympus announced today that it launched its EasySuite ES-IP system for procedure room visualization and integration in the U.S.

The next generation of EasySuite, ES-IP is a modular, scalable, workflow-based solution. It features the Olympus digital hub and its flexibility to run current software and potential future multi-specialty applications.

“We are excited to bring the power of the Olympus Digital Hub and our digital strategy to the core of our flagship EASYSUITE System,” said Shawn LaRocco, Vice President, Global Head Customer Solutions Business Unit. “The launch of  EASYSUITE™ ES-IP system represents Olympus’ commitment to delivering intelligent integrated solutions designed to improve patient care pathways and clinical operations. With an increasing reliance on IT, it’s essential that clinicians and nurses have the right data at the right time, allowing t…

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Study backs Olympus iTind for treating enlarged prostate

Olympus today announced positive study data for its minimally invasive iTind treatment for the symptoms of enlarged prostate.

The iTind procedure involves the placement of a temporary implanted nitinol device that reshapes the prostatic urethra. It does this without burning or cutting the prostate. Device placement can occur in an outpatient setting or physician office.

Olympus’ device remains in place for five to seven days while the patient stays at home. Upon removal, patients experience rapid and effective relief of their symptoms. Olympus acquired iTind when it acquired Medi-Tate, now a wholly-owned subsidiary, in May 2021.

It offers an alternative to pharmaceutical therapy, plus surgeries and permanent implants. It’s proven to relieve symptoms without affecting sexual and ejaculatory function or urinary continence.

Results from a long-term study showed long-lasting relief of more than four years for people with an enlarged prosta…

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Olympus to establish series of digital centers based on Odin Vision’s cloud-AI tech

Olympus announced that it plans to establish a series of digital excellence centers (DECs) following its acquisition of Odin Vision.

London-based Odin Vision develops a portfolio of commercially available computer-aided detection/diagnostic (CAD) solutions. It also holds an innovation pipeline of cloud-enabled applications. Olympus agreed to acquire cloud-based Odin Vision in a $79 million deal late last year. The company said the acquisition strengthened its strategy around initiatives in digital health. It aims to progress its AI-powered real-time diagnosis and minimally invasive treatment offerings.

Using Odin Vision’s solutions with its core endoscopy portfolio, Olympus plans to collect and analyze procedural, clinical and medical device data in real-time. Powered by a new, modern digital platform, the company seeks to reduce administrative and cognitive burdens while improving operational efficiency.

“As a leader in endoscopy and innovat…

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FDA clears Olympus endoscopy systems and endoscopes

Olympus’ Evis X1 endoscopy system [Image courtesy of Olympus]Olympus today announced it received FDA clearance for its new Evis X1 endoscopy system and two compatible gastrointestinal endoscopes.

The FDA clearance covers Olympus’ GIF-1100 gastrointestinal videoscope indicated for use in the upper digestive tract, and the CF-HQ1100DL/I colonovideoscope indicated for use in the lower digestive tract.

Olympus’s GI endoscopy systems are used by physicians to help diagnose, treat and observe diseases and disorders of the upper and lower GI tract, such as acid reflux, ulcers, Crohn’s disease, Celiac disease and colorectal cancer. According to the company, one of the most common uses of an endoscope is for screening colonoscopy, during which a physician examines the lining of the colon and removes cancerous growths. Olympus’ new imaging technologies can help physicians visualize abnormalities.

“We are thrilled that we will soon …

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FDA sends warning letter to Olympus over endoscope manufacturing

The FDA issued Olympus a warning letter regarding adultered devices following an inspection of the company’s Tokyo, Japan, facility.

This marks the latest warning letter sent by the FDA to Olympus. The company received two separate letters at the end of last year.

According to the letter, the agency conducted an inspection of the Tokyo firm between Nov. 7, 2022, and Nov. 10, 2022. It determined that the firm manufactures endoscopes and endoscope accessories. These include single-use distal covers for duodenoscopes and single-use suction valve accessories for bronchoscopes.

FDA said the inspection revealed that these devices “are adulterated.” This means that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation.

The agency said it received responses from Seiji…

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Olympus acquires GI stent maker Taewoong Medical for $370M

Olympus announced that it agreed to acquire Korea-based Taewoong Medical, a maker of medical devices including stents, for $370 million.

Taewoong Medical manufactures devices including gastrointestinal (GI) metallic stents. Olympus intends to use the acquisition to strengthen its GI endotherapy portfolio capabilities.

According to a news release, Olympus plans to pay approximately $370 million in cash to Taewoong. Of that total, the company intends to pay $255.5 million at closing. The remaining $114.5 depends on the completion of future milestones. Olympus expects to complete the transaction on June 30, 2023.

“For over three decades, Taewoong Medical has been a leading manufacturer of GI stents, renowned for its innovative technology and diverse product range,” said Kyong-min Shin, president and CEO of Taewoong Medical. “Our company has a robust market presence in Korea, Japan, and Europe, and exports to 86 countries worldwide. Moving …

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