MassDevice Archives - Page 188 of 587 - Medical Design Sourcing

ChoiceSpine launches new offering for anterior lumbar interbody fusion system

The Harrier SA. [Image from ChoiceSpine]ChoiceSpine announced today that it launched its Harrier SA lordotic offering for its standalone anterior lumbar interbody fusion system.

Knoxville, Tennessee-based ChoiceSpine designed Harrier SA as a 3D-printed, standalone, screw-based system. It incorporates the company’s proprietary BioBond porous structure technology.

Today’s launch includes the 20° lordotic offering to accompany the current 10° and 15° lordotic options. According to a news release, this provides further flexibility to the surgeon community in addressing different patient anatomies.

ChoiceSpine’s Harrier SA also features an integrated cam-locking mechanism. It includes a large graft window that the company says is “perfect” for combining with Stratofuse biologics. Additionally, it offers corticocancellous lag screws and seamless instrumentation.

“The addition of a hyperlordotic option for stand-alone ALI…

ResMed completes $1B acquisition of Medifox Dan

ResMed (NYSE:RMD) announced today that it completed its previously announced acquisition of Medifox Dan.

In June, ResMed announced an agreement to acquire Medifox Dan for €958.6 million ($984.5 million). Medifox Dan develops clinical, financial and operational software solutions for out-of-hospital care providers. It offers care documentation, personnel planning, administration and billing, among other things.

When the company announced the acquisition, it said it planned to fund the deal with its existing credit facilities. It expects the acquisition to be accretive to its adjusted diluted earnings per share.

Hildesheim, Germany-based Medifox Dan has more than 700 employees. It now operates under its current brand within ResMed’s software as a service (SaaS) business segment.

Medifox Dan offers solutions similar to those already belonging to the company’s leading U.S. SaaS brands. Those brands include MatrixCare and Brightree.

Res…

Neuralink co-founder unveils Science Eye sight restoration implant

The Science Eye. [Image from Science]Neuralink co-founder Max Hodak and the Science team unveiled the Science Eye, the company’s brain-computer platform.

Now the Science CEO, Hodak helped start Neuralink, Elon Musk’s venture into brain-computer interfaces (BCIs). He served as president there until 2021. He’s now working on a new brain-computer platform. Contrary to Neuralink and other companies’ platforms, this one doesn’t require an in-skull implant.

The Science Eye is a visual prosthesis. It targets retinitis pigmentosa (RP) and dry age-related macular degeneration (AMD), two forms of serious blindness. The combination device uses an optogenetic gene therapy targeted at the cells of the optic nerve. It combines that with an implanted, flexible thin-film, ultradense microLED display panel inserted directly over the retina.

Hodak, Yifan Kong, Alan Mardinly, Corey Wolin, Emma Zhou and the Science team authored a news release unv…

Medtronic reduces guidance amid slower procedures and supply recovery

Medtronic (NYSE:MDT) today reported second-quarter financial results that beat Wall Street expectations on earnings but missed on revenue.

In addition, the world’s largest medical device company reduced its guidance for the rest of the year amid slower market procedure volume recovery in some markets. While it worked through its most acute supply chain challenges, Medtronic resolved the problems later than expected in the quarter.

Investors reacted by sending MDT shares down more than 5% to $78.15 apiece in premarket trading.

Medtronic earned $427 million, or 32¢ per share, off $7.585 billion for the quarter ended Oct. 28. 2022. The bottom line was down 67%, and the top line was down 3% compared with Q2 2021.

Adjusted to exclude one-time items, Medtronic saw EPS of $1.30. The results were 2¢ ahead of The Street, where analysts expected adjusted EPS of $1.28 and $7.7 billion in revenue.

“Slower than predicted procedure and supply…

Teleflex announces another round of restructuring

Teleflex (NYSE:TFX) plans another round of restructuring — including manufacturing offshoring — to better position itself for long-term growth.

In a Form 8-K filed with the SEC today, the Wayne, Pennsylvania–based maker of critical care and surgical products said it expects to incur $31 million to $40 million in restructuring costs through 2023. About $18 million to $22 million of that amount involves termination benefits.

Teleflex did not specify how many workers it plans to lay off. It listed 14,000 employees in its most recent annual report.

Company officials said in the filing that they developed the restructuring plan to offset increasing costs and inflationary pressures in the healthcare industry.

The plan primarily involves relocating certain manufacturing operations to existing lower-cost locations, according to the company. In addition, Teleflex plans to streamline various business functions across the organization.

Teleflex expec…

Why are so many medical device companies making big investments in Ireland?

[Image from Ainars Djatlevskis on Unsplash] The foreign direct investment agency for Ireland has some of the biggest names in medtech investing in the country.

Within recent years, a number of major medtech companies celebrated anniversaries. Abbott’s was 70 years, Medtronic’s was 40 and Boston Scientific’s was 25.

That’s how long those companies have operated in Ireland.

Gerard Kilcommins, Medtronic VP of global manufacturing, vascular therapies and implants and country director in Ireland, said in a report earlier this year that its 40-year anniversary represents “an important milestone” in the company’s history.

“Our sites in Ireland have played a significant role in Medtronic’s evolution from medical device manufacturer to a global leader in healthcare technology,” Kilcommins said in July.

Each of those three companies, plus many more big names in medtech, choose Ireland for a broad range of inve…

Could minimally invasive neuromod tackle the opioid epidemic?

The Sparrow therapy system. [Image from Spark Biomedical] Officials at Spark Biomedical and AcuityMD think their partnership could accelerate the commercialization of Spark’s potentially game-changing platform.

Spark Biomedical develops a topical, minimally invasive medical device for alleviating opioid withdrawal symptoms. AcuityMD has a platform for helping medical device companies accelerate commercial access to their products.

Together, they seek to provide a pathway to life-restoring sobriety for millions suffering from opioid addiction. Last month, Spark and AcuityMD announced a partnership to accelerate the expansion of the former’s technology. The FDA-approved Sparrow therapy system represents a drug-free tool for helping treat opioid use disorder. It sends mild electrical impulses to the brain to help alleviate withdrawal symptoms.

AcuityMD’s data-driven commercial platform supports this expansion effort. It helps

“We saw an op…

Merit Medical announces launch of ‘EZ’ radial compression device

The PreludeSync EZ radial compression device [Image courtesy of Merit Medical Systems]Merit Medical Systems (NASDAQ: MMSI) today announced the U.S. launch of its PreludeSync EZ radial compression device.

South Jordan, Utah–based Merit Medical described the PreludeSync EZ as a unique cinch-style wristband. The company designed it to provide precise two-handed placement and clear visibility of the access site.

The goal is to optimize bleeding prevention for radial artery procedures. Think catheter-based delivery systems. For example, a doctor will run a catheter through a pinhole-sized site in the wrist to conduct minimally invasive scans and procedures around the heart.

The PreludeSync EZ provides a simplified alternative to the two-strap compression band currently on the market, according to the company. In addition, the PreludeSync EZ’s design features include a large window that provides clear visibility to further assist precise placement.

“…

TriSalus releases positive data for its catheter-based drug delivery tech

[Image from TriSalus]TriSalus Life Sciences today announced positive clinical results for its Pressure-Enabled Regional Immuno-Oncology technology.

The company, currently in the process of going public through a SPAC merger, filed a presentation for investors. It features information regarding its ongoing PERIO 01 and PERIO 02 clinical studies. The studies evaluate the TriNav pressure-enabled drug delivery technology for primary and metastatic liver tumors. It delivers SD-101, a class C toll-like receptor 9 (TLR9) agonist.

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

Study shows no difference in accuracy for skin color with Masimo pulse oximetry

[Image from Masimo]Masimo (Nasdaq:MASI) announced today that a study of its Masimo SET pulse oximetry demonstrated no difference in accuracy for different skin colors.

Irvine, California-based Masimo evaluated its pulse oximetry’s performance in varying skin pigmentation. It observed no clinically significant accuracy or bias between Black and White subjects.

The Journal of Clinical Monitoring and Computing published the retrospective trial. It studied subjects using Masimo SET pulse oximetry and Masimo RD SET sensors.

Masimo CSO Dr. Steven Barker and CMO Dr. William Wilson performed the retrospective analysis. It utilized Masimo laboratory data obtained from self-identified Black and White volunteer subjects.

Investigators reviewed data collected between October 2015 and July 2021. Data included 7,183 paired samples (3,201 Black and 3,982 White) collected from 75 subjects (39 Black and 36 White). Subjects received screening with the same crite…

Zimmer Biomet’s 3D-printed tibia receives FDA clearance

The Persona OsseoTi Keel Tibia. [Image from Zimmer Biomet]Zimmer Biomet (NYSE:ZBH) announced today that it received FDA 510(k) clearance for the Persona OsseoTi Keel Tibia.

Warsaw, Indiana-based Zimmer Biomet designed the system for cementless knee replacement. It represents the latest addition to the Persona Knee system platform.

Persona OsseoTi features a new porous version of the Persona anatomic tibia. It includes the Zimmer Biomet OsseoTi porous medical technology. That uses anatomical data with 3D printing technology.

The technology helps to build a structure that directly mimics the architecture of human cancellous (spongey) bone. Combined with a keeled design, it delivers stable initial and biological fixation, according to Zimmer Biomet.

Clearance helps Zimmer Biomet “close out the year” strong

“With an increasing number of surgeons opting for cementless procedures for their patients, we are excited to expand our market-lea…

Elizabeth Holmes receives 11-year prison sentence over Theranos fraud

Elizabeth Holmes back during her black turtleneck days at Theranos — in 2014 [Photo by Max Morse for TechCrunch TechCrunch – TechCrunch Disrupt San Francisco 2014, CC BY 2.0]A federal judge today sentenced Theranos founder Elizabeth Holmes to more than 11 years in prison for defrauding investors in the now-defunct blood testing company.

“What went wrong? This is sad because Ms. Holmes is brilliant,” said U.S. District Court Judge Edward Davila, according to media reports from NBC News, Variety and more. Davila went on to say that failure is normal, but failure by fraud is not OK.

In January, a federal jury in San Jose, California found Holmes guilty of four counts of wire fraud and conspiracy to commit wire fraud.

Holmes and her company Theranos once generated a great deal of buzz over claims that they were set to revolutionize blood testing with technology that could analyze tiny amounts of blood. Forbes in 2015 even recognized Holmes as …