Medical Design and Outsourcing Archives - Page 118 of 154

Madorra wins FDA breakthrough nod for home vulvovaginal atrophy treatment device

Madorra this week said it has received FDA breakthrough device designation for its noninvasive, home-use device for moderate to severe vulvovaginal atrophy.

Through the breakthrough device program, Madorra will have priority review and communication regarding the development of the device until the product goes on the market.

Madorra’s handheld device is designed as a prescription, noninvasive home-use device that applies ultrasound waves along the vaginal canal to stimulate local heat and blood flow and produce natural vaginal lubrication to alleviate symptoms of vulvovaginal atrophy (VVA).

Get the full story on our sister site, MassDevice.

Medtronic, Boston Scientific and Abbott fund new University of Minnesota Center for Medical Device Cybersecurity

(Image courtesy of the University of Minnesota)

The University of Minnesota and medical device manufacturers have partnered to launch an organization for cybersecurity research, outreach and workforce training.

Medtronic (NYSE:MDT) , Boston Scientific (NYSE: BSX), Abbott Laboratories (NYSE:ABT) , Smiths Medical and UnitedHealth Group’s (NYSE: UNH) Optum contributed financial support as founding partners of the University of Minnesota Center for Medical Device Cybersecurity.

The Center for Medical Device Cybersecurity will be part of the College of Science and Engineering’s Technological Leadership Institute and also collaborate with the Earl E. Bakken Medical Devices Center and the University of Minnesota’s Office of the Vice President for Research. The center will host roundtables, a hackathon, industry networking, training and offer summer internships and a medical device cybersecurity short cours…

Elizabeth Holmes trial opens, accused of ‘lying and cheating’

Theranos founder Elizabeth Holmes (center) arrives at federal court in San Jose, California on Aug. 31, 2021.[Photo by David Paul Morris/Bloomberg via Getty Images]

Ex-Theranos CEO Elizabeth Holmes’ federal fraud trial began yesterday with federal prosecutors claiming she lied and cheated to get money.

The prosecutors alleged on opening day that Holmes was manipulative and knowingly defrauded investors and patients through false and misleading claims.

“This is a case about fraud, about lying and cheating to get money. It’s a crime on Main Street, and it’s a crime in Silicon Valley,” said Assistant U.S. Attorney Robert Leach.

Get the full story on our sister site, MassDevice.

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.

Get the full story at our sister site, MassDevice.

Medtronic releases Navablate study results for bronchoscopic microwave ablation

Medtronic (NYSE:MDT) reported new clinical data from its Navablate study of bronchoscopic microwave ablation with its Emprint ablation catheter kit to treat malignant lung nodules.

“Patients with malignant lesions in the lung often have limited therapy options due to lesion locations, comorbidities and treatment side effects,” said one of the principal investigators, Kelvin Lau — consultant thoracic surgeon at St. Bartholomew’s Hospital in London — in a news release. “The results from the Navablate study explore the potential benefit of a more individualized treatment for patients and offer a new option for surgeons and physicians to provide a minimally invasive, localized treatment of malignant lesions in the lung.”

Surgeons in the United Kingdom and Hong Kong performed bronchoscopic ablation on 30 patients using Medtronic’s Emprint ablation catheter kit and the device maker’s electromagnetic navigation bronchoscopy system. Invest…

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.

FDA approves TransMedics’ OCS Heart system

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

Andover, Massachusetts-based TransMedics designed its OCS Heart system for use with organs from donors after brain death 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.

Get the full story at our sister site, MassDevice.

Jurors selected in Elizabeth Holmes’ Theranos fraud trial; start date set

Theranos founder Elizabeth Holmes (center) arrives at federal court in San Jose, California on Aug. 31, 2021. [Photo by David Paul Morris/Bloomberg via Getty Images]

The jurors who will weigh the evidence for and against Theranos founder Elizabeth Holmes were sworn in Thursday, setting the stage for the federal fraud trial to finally begin.

The twelve jurors — seven men and five women, all residents of California’s Santa Clara County — were selected along with five alternates (two men and three women) after two days of questioning by federal prosecutors, Holmes’ defense team and U.S. District Judge Edward Davila.

Potential jurors were asked how much they knew about the disgraced CEO and her company’s implosion to determine whether they could give her fair, unbiased consideration.

“There’s not that many women that get to become CEO of a high-powered company,” said one potential juror who expresse…

Baxter to acquire Hillrom for $12.4B

Baxter (NYSE:BAX) announced today that it entered into a definitive agreement to acquire Hillrom (NYSE:HRC) for approximately $12.4 billion.

Earlier this week, rumblings of a potential deal surfaced, leading to a massive rise for Hillrom’s stock. The expectation was that the companies would reach a deal by midweek so long as talks didn’t fall apart. Those reports saw Hillrom valued at about $150 per share, with estimates of a $10 billion deal.

Get the full story at our sister site, MassDevice.

Cleveland Clinic reports bionic arm breakthrough

[Photo courtesy of Cleveland Clinic]

Cleveland Clinic researchers say they’ve developed a bionic system that takes a big step toward restoring natural arm function for patients with upper limb amputations.

Upper-limb amputees often have to constantly watch their prosthetics while using them to make corrections in how much grasping force they use, but Cleveland Clinic said patients testing the new bionic arm system used it with less effort and an easier learning curve.

“Perhaps what we were most excited to learn was that they made judgments, decisions and calculated and corrected for their mistakes like a person without an amputation,” lead investigator Paul Marasco said in a news release. “With the new bionic limb, people behaved like they had a natural hand. Normally, these brain behaviors are very different between people with and without upper limb prosthetics.”

The bionic system combines a neu…

EMC requirements for medical power supplies

A look at IEC 60601-1-2 4th edition requirements

By Ron Stull, Power product marketing engineer

While the original IEC 60601-1 standard has existed now for 40 years, technology has evolved and the environments where medical equipment is used has grown more complex. This has led to the consideration of risks due to electromagnetic interference and a collateral standard on electromagnetic compatibility.

In the following post we will take a look at IEC 60601-1-2 4th edition EMC collateral standard, how it relates to medical power supplies, and its effective date in each region.

IEC 60601-1-2 4th edition requirements

The underlying premise of IEC 60601-1 is understanding and managing risk, which the 3rd edition developed by defining electrical performance requirements for safe operation in terms of the means of protection for both patients and operators. Principally this determined isolation, creepage and insulation specifications for differen…

FDA clears MiRus expandable lumbar system

MiRus today said it received FDA 510(k) clearance for its IO expandable lumbar interbody.

Marietta, Georgia-based MiRus designed the expandable lumbar interbody to be used in PLIF and TLIF procedures. It has a low insertion profile at 4 mm, an expansion of 18 mm and a 24º lordosis.

“The FDA approval of the IO expandable lumbar interbody is a breakthrough for surgeons and patients wishing truly less invasive spine surgery,” founder and CEO Jay Yadav said in a news release. “It also marks a significant milestone in our development of complex rhenium-based medical implants.”

The one-step expandable implant allows for 2.5cc of biologic to be post-packed in the intervertebral space. It also allows for minimization of insertion height and maximization of expansion height, lordosis to make it easier for surgeons to restore lordosis, maintain sagittal balance and reduce insertion and related neural injury challenges, according to the comp…