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Medtronic warns on previous software MiniMed 780G in Germany

The MiniMed 770G system. [Image from Medtronic]Medtronic (NYSE: MDT) + issued an urgent field safety notice in Germany to warn of a potential issue with its MiniMed 780G system.

MiniMed 780G, Medtronic’s next-generation automated insulin delivery system, has been available in Europe since earning CE mark in mid-2020. In March 2021, the company first communicated that its pumps with software version 6.5 could present pump errors. These occur after the delivery of a large bolus at quick bolus speed under certain conditions.

With its notice, Medtronic informed customers in Germany that they can exchange their current pumps for an updated version for free. Those with MiniMed 780G pumps with software version 6.5 can change to a pump with software version 6.7. This eliminates the potential occurrence of these errors so users can use the pump for boluses over 17.1 units at quick bolus speed.

This issue only impacts …

Haemonetics to acquire OpSens for more than $250M, expanding cardiology device portfolio

Haemonetics (NYSE: HAE) + today announced a definitive agreement to acquire cardiology-focused technology developer OpSens.

Boston-based Haemonetics will acquire all outstanding shares of Opsens for CAD $2.90 in an all-cash transaction that will have a fully diluted equity value of approximately $253 million USD. The transaction is expected to close by the end of January 2024.

Opsens develops optical technology for use in interventional cardiology. Its products include the SavvyWire and OptoWire.

SavvyWire is a sensor-guided 3-in-1 guide wire for TAVR procedures that acts as a pacing and pressure monitoring wire that advances the workflow of the procedure for shorter hospital stays. OptoWire is a pressure guide wire that aims to improve clinical outcomes by accurately and consistently measuring fractional flow reserve (FFR) and diastolic pressure ratio to help clinicians in the diagnosis and treatment of coronary …

State of the industry — Execs ‘more bullish than ever’ on medtech

From left: Kevin Lobo, Lisa Earnhardt, Deepak Nath, Bernard Zovighian. All spoke about the state of the industry at The MedTech Conference.

Ernst & Young’s 2023 Pulse of the Industry medical technology report may not have been overly positive, but medtech executives certainly are.

The EY report highlighted sluggish revenues and post-COVID-19 corrections leading to a growth decline. In fact, it was the lowest growth in medtech since 2015. Roughly half of medtech stock price gains realized in 2021 were wiped out by the end of 2022.

However, leading medtech executives, including Stryker CEO Kevin Lobo, only see upwards.

“I feel as bullish as I’ve ever felt in my time in medtech,” Lobo declared.

Lobo, Abbott EVP of Medical Devices Lisa Earnhardt, Smith+Nephew CEO Deepak Nath and Edwards CEO Bernard Zovighian all have positive outlooks for the space. They outlined their views on a panel based around the EY report Monday at T…

Report: Boston Scientific to open first China factory in Shanghai

According to reports, U.S.-based medtech company Boston Scientific (NYSE: BSX) + says it intends to open its first factory in China.

Reuters reported that Boston Scientific shared the news in a statement on its WeChat social media account. The report said the company shared its interest in expanding regional production in supply chains. Its factory will be in Lingang, a free trade zone in Shanghai, focusing on production for the China market. According to Reuters, the Shanghai government promotes this area as a “landing base” for developers of semiconductors, electric vehicles and pharmaceuticals.

Boston Scientific outlined China as a serious area of focus at its recent Investor Day event on Sept. 20. Chair and CEO Mike Mahoney describes the country as “one of the most attractive medtech markets.” The company sees “unmatched” growth, scale and a worthwhile innovation ecosystem within the country.

Jun…

Philips takes steps to improve health monitoring, care coordination with open ecosystem

[Image courtesy of Philips]Philips (NYSE: PHG) + today announced interoperability between its Philips Capsule and Philips Patient Information Center iX (PIC iX).

Interoperability between the Capsule medical device information platform (MDIP) and PIC iX offers hospitals a first-of-its-kind, comprehensive patient overview. Philips aims to create an open patient monitoring ecosystem, bringing together disparate devices and systems on a single interface.

In early 2021, Philips acquired Capsule Technologies in a deal worth $635 million. This technology now helps to enable the interoperability the company is offering. Speaking to MassDevice at The MedTech Conference, Julia Strandberg, chief business leader of monitoring & connected care, explained what this open ecosystem offers.

“The intention is to have vendor-neutral data coming in, in real-time and waveform data,” Strandberg said. “There’s…

‘Love, yet fear’ — how medtech is stepping into the digital sphere

Robert Cohen of Stryker offered his thoughts on how medtech is adopting digital technologies. [Photo courtesy of Stryker]Dr. Rajiv Sethi likes to compare the implementation of digital technologies and automation in medtech to the automation in an airplane.

If the pilots experienced an issue with their technology or the weather, for instance, they could manually interject, he says. But, the “vast majority of the work” goes down to automation.

Sethi serves as a clinical professor for health systems and population health and executive director of the Center for Neurosciences and Spine at the University of Washington School of Medicine and Virginia Mason Medical Center. He explained his airplane and operating room analogy today at AdvaMed’s The MedTech Conference in Anaheim, California.

Sethi spoke on a panel titled “Digital is the New Frontier: Are We Stepping Into it Boldly?” (Want to find out more about digital surgery, artifici…

FDA grants de novo nod to HistoSonics histotripsy system

The Edison histotripsy system. [Image courtesy of HistoSonics]HistoSonics announced today that the FDA granted de novo authorization for its Edison system and novel histotripsy therapy platforms.

Edison, an image-guided sonic beam therapy system uses advanced imaging and proprietary sensing technology. It delivers non-invasive, personalized treatments with precision and control. The system received FDA investigational device exemption in February. In March, HistoSonics announced the first kidney tumor treatment with its novel therapy system.

The company believes Edison’s mechanism of action could provide significant advantages to patients. Those include the ability of the treatment site to recover and resorb quickly. Additionally, the platform enables physicians to monitor the destruction of tissue under continuous, real-time visualization and control.

Minneapolis-based HistoSonics says the de novo nod makes Edison the first and only histotripsy platf…

Endotronix wins FDA IDE for Cordella pressure-guided therapy trial

The Cordella system. [Image courtesy of Endotronix]Endotronix announced today that the FDA granted it investigational device exemption (IDE) to conduct a study for its Cordella sensor.

The study evaluates the use of Cordella in pulmonary artery (PA) pressure-guided therapy. PROACTIVE-HF 2, a prospective, dual-arm trial, aims to expand access for heart failure patients. Endotronix seeks to support efficient and scalable remote patient management with a clinician-directed self-management strategy.

According to a news release, the company expects to enroll up to 1,500 patients in the U.S. and Europe. It anticipates the first patient enrollment later this year.

PROACTIVE-HF 2’s randomized arm assesses the safety and efficacy of PA pressure-guided therapy using Cordella. That arm evaluates NYHA Class II patients at risk for congestion. In both cohorts, patients and clinicians can access daily trended telehealth data. The treatment cohort can also access da…

WhiteSwell fluid removal system produces positive study results

WhiteSwell announced positive initial results from its DELTA-HF trial evaluating its eLym system for excess fluid removal.

Galway, Ireland-based WhiteSwell designed eLym to treat acute decompensated heart failure (ADHF). It presented data at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2023 in Cleveland, Ohio.

The study evaluates the eLym minimally invasive catheter-based system. eLym facilitates the removal of excess fluid from the body’s tissues and organs concurrent with diuretic removal of excess vascular fluid. The system targets the body’s largest lymphatic vessel and creates pressure conditions. These conditions support the tissue drainage capabilities of the overwhelmed lymphatic system.

Clinicians deploy e the left internal jugular and innominate veins near the thoracic duct. It creates a low-pressure zone to facilitate fluid drainage in conjunction with intravenous diuretics.

In DELTA-HF, nine hospita…

J&J’s DePuy Synthes wins FDA clearance for TriAltis tech

The TriAltis Spine system. [Image courtesy of DePuy Synthes]Johnson & Johnson MedTech announced today that its DePuy Synthes unit won FDA 510(k) clearance for two TriAltis technologies.

The FDA cleared the company’s TriAltis Spine system and the TriAltis navigation-enabled instruments. TriAltis Spine is a next-generation posterior thoracolumbar pedicle screw system. It offers a comprehensive implant portfolio and advanced instrumentation for integration with enabling technology.

DePuy Synthes’ TriAltis navigation-enabled instruments include drills, taps and screwdrivers. These offer manual operation or power operation for navigated and non-navigated use.

The company said combining its implants with a digital ecosystem can address unmet clinical needs. Its TriAltis Spine system could help surgeons achieve more consistent outcomes in treating complex spine conditions, too. That includes degenerative tumor, trauma and deformity pathologies.

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GE HealthCare launches AI-enhanced point-of-care ultrasound

Caption Guidance on the Venue Go system in use. [Image courtesy of GE HealthCare]GE HealthCare (Nasdaq: GEHC) + announced today that it launched its Venue point-of-care ultrasound systems with AI-driven Caption Guidance.

Chicago-based GE HealthCare says the Venue family is the first of its ultrasound guidance to include Caption Guidance. The company added the AI-driven imaging guidance to its arsenal when it acquired Caption Health earlier this year.

Caption Guidance, an optional add-on, offers new capabilities at the point of care with diagnostic-quality cardiac images. It supports clinicians in a wide range of clinical settings, like emergency departments, critical care wards and anesthesiology.

GE HealthCare says the Caption Guidance technology offers clinicians step-by-step instructions to acquire ultrasound for cardiac assessments. It helps providers — even those who aren’t ultrasound experts — by addres…

LivaNova adds former NuVasive CEO to its board

New LivaNova board director J. Christopher Barry. [Image from NuVasive]LivaNova (Nasdaq: LIVN) + announced today that it appointed J. Christopher Barry as a new board director.

Barry’s appointment becomes effective today and he joins the board’s Audit and Compliance Committee. In turn, Andrea Saia intends to retire from the board on Dec. 31, 2023. Saia initially joined the board of the London-based medtech company as a director in 2016.

With the changes, the LivaNova board will include 10 directors until Saia’s retirement at the end of the year.

“The LivaNova board of directors is pleased to welcome Chris Barry,” said Bill Kozy, interim CEO and chair of LivaNova. “Chris has spent his career in the medical technology industry, and we look forward to adding his commercial expertise and ability to drive long-term growth to the board. Additionally, on behalf of the entire board, I’d like to thank Andr…