MassDevice Archives - Page 383 of 587 - Medical Design Sourcing

Stryker completes Gauss Surgical acquisition

Stryker (NYSE:SYK) announced today that it acquired Gauss Surgical and its Triton platform for an undisclosed amount.

Menlo Park, California-based Gauss Surgical designed the Triton artificial intelligence-enabled platform for the real-time monitoring of blood loss during surgery. The platform has demonstrated improvements in maternal and surgical care through earlier recognition of hemorrhage leading to earlier intervention, according to a news release.

Kalamazoo, Michigan-based Stryker cited studies that suggest that up to 5% of mothers experience a post-partum hemorrhage, which constitutes the leading cause of maternal death globally, and studies suggest that 70% of those are preventable through monitoring platforms like Triton.

“Gauss Surgical’s innovative Triton technology will help fill the void of quantifying blood loss to enable accuracy, early detection of hemorrhage and prevention of maternal morbidity,” Dylan Crotty, Presiden…

Envista selling its KaVo unit to Planmeca for up to $455M

Envista this week announced that it has entered into a binding agreement to sell its KaVo treatment unit and instrument business to Planmeca for up to $455 million.

Through the deal, Planmeca will pay up to $455 million with a potential earn-out payment of up to $30 million. The sale is expected to close at the end of this year.

The KaVo treatment unit and instruments is a manufacturer and supplier of dental treatment units and instruments. The business to be sold is part of Envista’s equipment and consumables segment. Envista’s imaging business will remain a part of the company as part of the equipment and consumables segment.

“Envista is focused on its strategic priorities to build and optimize a more consumables and digitally-enabled, workflow-oriented portfolio. This sale will better position Envista to invest organically and inorganically and expand our product offerings within these areas,” CEO Amir Aghdaei said in a news release.…

Eli Lilly to donate nearly $1M to Type 1 diabetes initiative

Eli Lilly (NYSE:LLY) announced today that it will commit nearly $1 million over the next three years toward helping children with type 1 diabetes.

Indianapolis-based Eli Lilly, in a joint effort with the Leona M. and Harry B. Helmsley Charitable Trust, seeks to promote greater access to care and resources while inspiring confidence for children living with Type 1 diabetes through the Type 1 Diabetes Camps Initiative.

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

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Illumina, Merck partner on diagnostics for identifying specific cancer mutations

Illumina (NSDQ:ILMN) and Merck today announced a partnership to develop diagnostics for identifying certain genetic mutations.

The partnership aims to develop and commercialize tests that identify genetic mutations used in the assessment of homologous recombination deficiency (HRD), leveraging Illumina’s TruSight Oncology 500 (TSO 500) content, enabling what the companies tout as the most comprehensive genomic profiling assays in a single worfklow.

San Diego-based Illumina said in a news release that the partnership builds upon an initial study conducted between the two companies and uses Illumina’s relationship with Myriad Genetics to expand international access to the proprietary technology in Myriad’s FDA-approved myChoice CDx companion diagnostic test.

Under the partnership, Illumina will develop a new HRD CDx test for the European Union and the UK to aid in the identification of ovarian cancer patients with positive HRD status who …

AFYX touts trial of biodegradable drug delivery patch

AFYX Therapeutics today touted results from a study exploring the delivery of antibody fragments using the company’s Rivelin technology.

The preclinical study, conducted in collaboration with the University of Sheffield in the United Kingdom, evaluated Rivelin for delivering the antibody fragments directly to inflamed tissue in mucosal diseases.

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

TriSalus enrolls first patient in pressure-enabled drug delivery trial for treating melanoma

TriSalus Life Sciences announced today that it enrolled the first patient in its clinical study of a treatment for metastatic uveal melanoma.

The PERIO-01 clinical study evaluates SD-101, an investigational toll-like receptor 9 (TLR9) agonist in adults with metastatic uveal melanoma through intravascular administration into uveal melanoma liver metastasis lesions in combination with checkpoint inhibitors using the novel pressure-enabled drug delivery (PEDD) approach.

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

RenovoRx wins FDA clearance for RenovoCath delivery system

RenovoRx today said it received FDA 510(k) clearance for its RenovoCath delivery system.

Los Altos, California-based RenovoRx designed the system as the device component for its RenovoGem and is a drug/device combination used in the company’s RenovoTAMP trans-arterial micro-perfusion therapy. The system is a dual-balloon infusion catheter that delivers chemotherapy directly to tumors through the arteries.

Get the full story on our sister site, Medical Tubing + Extrusion.

FDA approves TransMedics’ OCS Heart system

Transmedics (NSDQ:TMDX) announced today that it received FDA premarket approval (PMA) for its OCS Heart system.

Andover, Massachusetts-based TransMedics designed its OCS Heart system for use with organs from donors after brain death (DBD) with indication for preserving donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged cold static cardioplegic preservation, according to a news release.

The indication comes on the back of results from the OCS Heart Expand trial, the associated OCS Heart Expand continued access protocol (CAP) and the OCS Heart Proceed II trial, the company said.

Premarket approval follows FDA approval for and the subsequent commercialization of the OCS Lung system as the company continues to seek FDA approval for the OCS Liver system, for which an FDA advisory panel issued a favorable vote supporting approval in July.

“We are thrilled to achieve this importa…

FDA approves Impel NeuroPharma’s nasal spray for treating migraines

Impel NeuroPharma (NSDQ:IMPL) announced today that the FDA approved its Trudhesa nasal spray for treating migraine in adults.

Seattle-based Impel NeuroPharma plans to launch Trudhesa commercially early next month. The company’s shares took a massive hit, though, dropping -19.3% at $18.65 per share by market close and continuing to slide down -0.8% at $18.50 after hours today.

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

Johnson & Johnson seeks nominees for women STEM scholars awards

Johnson & Johnson (NYSE:JNJ) announced that it is accepting applications for its 2022 Women in STEM2D (WiSTEM2D) Scholars Award.

New Brunswick, N.J.-based Johnson & Johnson’s award aims to support assistant or associate academic professors in the disciplines of science, technology, engineering, math, manufacturing and design through three years of mentorship from leaders at the company and a total of $150,000 ($50,000 each year), according to a news release.

The company launched the Johnson & Johnson WiSTEM2D Scholars Award in June 2017 in an effort to fuel the development of female STEM2D leaders and inspire career paths in STEM2D by supporting the research of the awarded women in their respective fields.

An independent external advisory board will select the 2022 winners, each of whom will go on to represent one of the STEM2D disciplines.

“COVID-19 has shown us that investment…

Glaukos submits supplemental PMA application for iStent Infinite

Glaukos (NYSE:GKOS) announced today that it submitted a supplemental premarket approval application to the FDA for its iStent Infinite system.

San Clemente, California-based Glaukos designed the iStent Infinite trabecular micro-bypass system for use in a standalone procedure to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma uncontrolled by prior surgery or medical therapy.

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