Medical Design and Outsourcing Archives - Page 48 of 154

‘This AI-based smartphone helps diabetes patients manage blood sugar’

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[Image courtesy of OHSU]

Oregon Health & Science University (OHSU) combined AI and diabetes experts to develop a smartphone app to help manage blood sugar levels.

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OHSU biomedical engineer Peter Jacobs and OHSU endocrinologist Dr. Leah Wilson lead this project. They plan to organize a randomized clinical trial to evaluate an enhanced app used in concert with diabetes education specialists. The Leona M. and Harry B. Helmsley Charitable Trust awarded the university more than $4.3 million to support the work.

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The researchers developed the DailyDose app for people managing type 1 diabetes with multiple daily insulin injections. It uses an AI algorithm to evaluate blood sugar data, identify trends and recommend steps to keep glucose in range.

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Get the full story at our sister site, Drug Delivery Business News.

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This AI-based smartphone helps diabetes patients manage blood sugar

[Image courtesy of OHSU]

Oregon Health & Science University (OHSU) combined AI and diabetes experts to develop a smartphone app to help manage blood sugar levels.

OHSU biomedical engineer Peter Jacobs and OHSU endocrinologist Dr. Leah Wilson lead this project. They plan to organize a randomized clinical trial to evaluate an enhanced app used in concert with diabetes education specialists. The Leona M. and Harry B. Helmsley Charitable Trust awarded the university more than $4.3 million to support the work.

The researchers developed the DailyDose app for people managing type 1 diabetes with multiple daily insulin injections. It uses an AI algorithm to evaluate blood sugar data, identify trends and recommend steps to keep glucose in range.

Get the full story at our sister site, Drug Delivery Business News.

FDA hits Olympus with warning letters after factory inspections

The FDA today released warning letters against Olympus Medical Systems Corp. and Olympus Corp. subsidiary Aizu Olympus following inspections of their endoscope and reprocessor manufacturing facilities.

The warning letters allege medical device reporting (MDR) and quality system violations at the manufacturing operations.

An Olympus representative told Medical Design & Outsourcing that the medtech manufacturer would issue a public response as soon as today.

FDA issued the first letter to Aizu Olympus President and CEO Yasuo Takeuchi on Nov. 2, 2022, following a July 5-8 inspection. The warning letter covers the company’s endoscope and automated reprocessing equipment manufacturing operations in Aizuwakamatsu, Fukushima, Japan.

FDA issued the second letter to Olympus Medical Systems President Tomohisa Sakurai on Dec. 12, 2022, following a Sept. 6-9 inspection. That warning letter covers the company’s gastrointestinal and surgical end…

FDA hits Olympus with warning letters after factory inspections

The FDA today released warning letters against Olympus Medical Systems Corp. and Olympus Corp. subsidiary Aizu Olympus following inspections of their endoscope and reprocessor manufacturing facilities.

The warning letters allege medical device reporting (MDR) and quality system violations at the manufacturing operations.

“Olympus’ highest priority is providing patients and users with safe and effective medical devices that comply with all applicable legal and regulatory requirements,” the company said in a statement to Medical Design & Outsourcing. “For that reason, we are committed to working together with FDA to address concerns.”

FDA issued the first letter to Aizu Olympus President and CEO Yasuo Takeuchi on Nov. 2, 2022, following a July 5–8 inspection. The warning letter covers the company’s endoscope and automated reprocessing equipment manufacturing operations in Aizuwakamatsu, Fukushima, Japan.

FDA issued …

Canon Medical Systems inks strategic partnership with ScImage

Canon Medical Systems USA announced that it completed a strategic partnership with cloud-native enterprise image management company ScImage.

Los Altos, California-based ScImage also provides PACS and image exchange solutions for the healthcare industry.

The two companies plan to use the partnership to broaden and advance Canon’s outreach in hemodynamics with its Fysicon QMAPP Hemo portfolio. As a result, Canon expects to increase its presence in the cardiac market. This includes offering innovative solutions and business models tailored to each client’s specific needs.

Canon’s Fysicon subsidiary designed QMAPP Hemo as a user-friendly option mounted to a standard interventional X-ray or operating table. It offers efficiency in the interventional lab without losing patient or exam data, according to a news release.

ScImage founder and CEO Sai Raya noted that the companies have “a shared vision and perfectly complementary prod…

Canon Medical Systems inks strategic partnership with ScImage

Canon Medical Systems USA announced that it completed a strategic partnership with cloud-native enterprise image management company ScImage.

Los Altos, California-based ScImage also provides PACS and image exchange solutions for the healthcare industry.

The two companies plan to use the partnership to broaden and advance Canon’s outreach in hemodynamics with its Fysicon QMAPP Hemo portfolio. As a result, Canon expects to increase its presence in the cardiac market. This includes offering innovative solutions and business models tailored to each client’s specific needs.

Canon’s Fysicon subsidiary designed QMAPP Hemo as a user-friendly option mounted to a standard interventional X-ray or operating table. It offers efficiency in the interventional lab without losing patient or exam data, according to a news release.

ScImage founder and CEO Sai Raya noted that the companies have “a shared vision and perfectly complementary prod…

ResMed’s new factory brings it closer to meeting CPAP demand after Philips recall

The AirSense 11 CPAP system [Image courtesy of ResMed]

The opening of a new plant — billed as the biggest of its kind on Earth — brings ResMed closer to catching up with skyrocketing CPAP demand.

That was one of the big takeaways from ResMed CEO Mick Farrell’s talk at the annual J.P Morgan Healthcare Conference in San Francisco yesterday. The San Diego–based company has found supply chain challenges hindering its ability to meet the demand that surged after a serious recall forced competitor Philips out of the market.

“Every month and every quarter we get closer to meeting that demand,” Farrell said.

ResMed held a grand opening for the 270,000-square-foot Singapore plant in November. Farrell yesterday described it as the biggest respiratory devices manufacturing facility on the planet.

“We have the capability in that plant to take the whole of the market’s need…

ResMed’s new factory brings it closer to meeting CPAP demand after Philips recall

The AirSense 11 CPAP system [Image courtesy of ResMed]

The opening of a new plant — billed as the biggest of its kind on Earth — brings ResMed closer to catching up with skyrocketing CPAP demand.

That was one of the big takeaways from ResMed CEO Mick Farrell’s talk at the annual J.P Morgan Healthcare Conference in San Francisco yesterday. The San Diego–based company has found supply chain challenges hindering its ability to meet the demand that surged after a serious recall forced competitor Philips out of the market.

“Every month and every quarter we get closer to meeting that demand,” Farrell said.

ResMed held a grand opening for the 270,000-square-foot Singapore plant in November. Farrell yesterday described it as the biggest respiratory devices manufacturing facility on the planet.

“We have the capability in that plant to take the whole of the market’s need…

Abbott and Blood Centers of America tap mixed reality to boost donations

A blood donor wearing a Microsoft Hololens 2 headset for a mixed reality experience while giving. [Photo courtesy of Abbott]

Mixed reality technology will aim to ease and entertain blood donors while they’re in the chair under a pilot program from Abbott and Blood Centers of America.

Blood donors wearing mixed reality (a combination of virtual reality and augmented reality) headsets will find themselves in “a whimsical garden while listening to soothing music, planting seeds that grow into colorful trees and flowers,” Abbott said in a news release.

It’s an effort to improve the blood donation process and attract new donors, particularly younger people, to bolster the nation’s blood supply.

“Not only is it an immersive and unique use of mixed reality controlled completely through eye tracking, it’s a high-tech and creative way to improve the donation experience a…

Could mixed reality boost blood donations?

A blood donor wearing a Microsoft HoloLens 2 headset for a mixed reality experience while giving. [Photo courtesy of Abbott]

Mixed reality technology will aim to ease and entertain blood donors while they’re in the chair under a pilot program from Abbott and Blood Centers of America.

Blood donors will wear mixed reality (a combination of virtual reality and augmented reality) headsets. They will find themselves in “a whimsical garden while listening to soothing music, planting seeds that grow into colorful trees and flowers,” Abbott said in a news release.

It’s an effort to improve the blood donation process and attract new donors, particularly younger people. The goal is to bolster the nation’s blood supply.

“Not only is it an immersive and unique use of mixed reality controlled completely through eye tracking, it’s a high-tech and creative way to improve the d…

European Commission endorses MDR transition delay

EU Commissioner for Health and Food Safety Stella Kyriakides [Photo courtesy of the European Commission]

An MDR transition delay is one step closer to reality following concerns that the current timeline could lead to medical device shortages.

The European Commission on Jan. 6 officially endorsed a proposal to give medical device manufacturers more time to certify their devices under new Medical Devices Regulation (MDR) rules. The proposed MDR transition delay will not become official without approval by the European Parliament and Council.

The proposal would not change any of MDR’s current safety and performance requirements. Instead, it would give manufacturers more time to move from the old rules to the new requirements. It would remove the “sell-off” date and extend transition periods.

RELATED: Navigating MDR’s newly charted waters

MDR went into effect in May 2021 with…

Resonetics to buy SAES Medical nitinol business for $900M

Resonetics announced today that it has signed an agreement to acquire Memry Corp. and SAES Smart Materials from SAES Getters S.p.A, Milan, Italy.

The planned acquisition will expand Nashua, New Hampshire–based Resonetics’ nitinol raw material and component manufacturing capabilities.

The companies expect the $900 million deal to close this year. The transaction is subject to the receipt of regulatory clearances and approvals. In addition, there are other closing conditions, including the approval of the SAES Getters S.p.A. board of directors.

Both of the businesses that Resonetics is acquiring are U.S. based. They have 550 employees and operations in Bethel, Connecticut; New Hartford, New York; and Menlo Park, California.

The deal enables Resonetics to better serve a wide range of medtech

Nitinol is enabling technological advances in a range of therapeutic areas, such as structural heart, peripheral vascular, electrophysiology, neurovascular…