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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Olympus to acquire cloud-AI endoscopy startup Odin Vision

Olympus announced today that it agreed to acquire cloud-based AI endoscopy technology developer Odin Vision.

The agreement totals up to $79 million in upfront and milestone-based payments.

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 applciations.

Clinicians and AI experts at the Wellcome / EPSRC Centre for Interventional and Surgical Sciences (WEISS) at University College London (UCL) founded Odin Vision. They created it with a mission to offer digital technology for a “new era” of healthcare supporting doctors to deliver higher quality care. The company aims to improve patient outcomes and patient experience while increasing value for healthcare providers.

Olympus said in a news release that Odin Vision aims to “create a paradigm shift” in AI integration for endoscopy. The company seeks to …

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Olympus launches power morcellator with FDA-advised changes

Olympus today announced the U.S. market launch of its Moresolution power morcellator, saying it supports the safe use of the gynecologic devices under FDA guidance.

In 2020, the FDA issued final guidance on power morcellators after the devices faces questions about potentially spreading cancer. The agency recommended limiting laparoscopic power morcellation (LPM) to use with certain tissue containment systems. It also only recommended the procedure only for premenopausal, under-50 women who have suspected fibroid tumors.

Moresolution operates in conjunction with the PneumoLiner, which Olympus describes as a first-of-its-kind containment device. The company says its Olympus Contained Tissue Extraction System provides select patients with a laparoscopic surgical option. As a result, it’s a tissue-removal alternative to an open hysterectomy or open myomectomy.

Olympus said Moresolution can cut dense or calcified fibroids. In addition, its efficient cu…

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Olympus applauds CMS move to expand access to colonoscopies

Olympus says CMS recently took a significant step forward to boost colorectal cancer care in the U.S.

CMS, on Nov. 1, announced that it will eliminate Medicare cost-sharing for a follow-up colonoscopy after an at-home stool test returns a positive result. Defining such colonoscopies as preventative services means that Medicare beneficiaries will no longer have out-of-pocket costs for both tests.

Medicare has also reduced the minimum age for colorectal cancer screening from 50 to 45 years.

“These rule changes represent a significant step toward improving colorectal cancer care and expanding access to preventive screenings,” said Paul Skodny, executive director of Global Health Economics & Market Access at Olympus Corp. of America.

“The American Society for Gastrointestinal Endoscopy (ASGE) considers colonoscopy the gold standard for screening, but the procedure may not be readily available to everyone. That’s why it̵…

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Olympus’ Evident opens new Asia-Pacific HQ

The Evident APAC headquarters. [Image from Evident]

Olympus‘ Evident announced that it opened its new Asia-Pacific headquarters in Singapore as it looks to expand in the APAC region.

In April, Olympus completed the separation of its Scientific Solutions Division into a wholly-owned subsidiary called Evident. The move aimed to provide more room to focus on the continued growth of the company’s Medical Business.

Get the full story at our sister site, MassDevice.


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