Medical Design and Outsourcing Archives - Page 117 of 154

First witnesses in Elizabeth Holmes federal fraud trial take the stand

Former Theranos CEO Elizabeth Holmes leaves after a hearing at a federal court in San Jose, Calif., on July 17, 2019. [Image courtesy of Reuters/Stephen Lam]

Two of the prosecution’s witnesses took the stand yesterday on the second day of Elizabeth Holmes’ federal fraud trial.

Theranos’ former financial controller San Ho Spivey, who is referred to as Danise Yam, took the stand and testified the company’s financial condition during its heyday.

Yam told Assistant U.S. Attorney Robert Leach that Theranos had net losses of $16.2 million in 2010, $27.2 million in 2011, $57 million in 2012 and $92 million in 2013, CNBC reports. Yam also testified that Theranos made no revenue in 2012 and 2013 and that the company was spending nearly $2 million per week in 2013.

Get the full story on our sister site, MassDevice.

Axonics loses IP challenge to Medtronic patents

Medtronic (NYSE:MDT) announced that it picked up three victories in an intellectual property (IP) dispute against Axonics (NSDQ:AXNX) over sacral neuromodulation devices.

According to a news release, the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) rejected Axonics’ attempt to invalidate three Medtronic patents in its IP infringement lawsuit related to Medtronic’s InterStim neuromodulation device family. Nearly one year ago, the PTAB handed down a decision to reject one of Axonics’ claims to invalidate a Medtronic patent and has now added three more.

Get the full story at our sister site, MassDevice.

Cepheid wins EUA for new version of COVID-19, flu, RSV combination diagnostic

Cepheid announced today that it received FDA emergency use authorization (EUA) for its Xpert Xpress CoV-2/Flu/RSV Plus diagnostic.

Sunnyvale, California-based Cepheid designed its Xpert Xpress Plus as a rapid molecular diagnostic test for the qualitative detection of the viruses causing COVID-19, Flu A, Flu B and respiratory syncytial virus (RSV).

Get the full story at our sister site, MassDevice.

Stratasys expands anatomical modeling services for healthcare

A Stratasys 3D printed anatomical model of a spinal pedicel screw insertion (Photo courtesy of Stratasys)

Stratasys Direct Manufacturing now offers anatomical modeling and consultative services for the healthcare industry.

The Stratasys (NASDAQ: SSYS) subsidiary opened its new Healthcare Print Center in Eden Prairie, Minnesota, and soft-launched the new offerings with an invite-only beta test for medical device manufacturers. Over the past 13 weeks, Stratasys J750 Digital Anatomy printers have created more than 1,000 models, with each printer running more than 120 hours per week.

The printers build life-like medical and dental anatomical models for medical device manufacturers and healthcare providers to use in device testing, medical training, or surgical preparation and consultation. Stratasys launched the printers in 2019 and updated them with biomechanically realistic bone capabilities in 2020. Read more

FDA clears NeuroOne’s Evo sEEG electrode

NeuroOne Medical Technologies (NMTC) announced that it received FDA 510(k) clearance for its Evo sEEG electrode technology.

Eden Prairie, Minnesota-based NeuroOne’s Evo sEEG electrode technology received clearance for temporary (less than 24 hours) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain, according to a news release.

Get the full story at our sister site, Mass Device.

Cardinal Health docks executive bonuses over opioid costs

Cardinal Health CEO Mike Kaufmann (Photo courtesy of Cardinal Health)

Cardinal Health’s board of directors reduced bonus payouts for CEO Mike Kaufmann and his four top-paid executives due to the cost of opioid litigation.

After pressure from investors, Cardinal Health (NYSE:CAH) for the first time has disclosed how its board of directors factored the opioid litigation settlement costs into the pay packages of Kaufmann, Chief Financial Officer Jason Hollar, Pharmaceutical Segment CEO Victor Crawford, Medical Segment CEO Stephen Mason and Chief Legal and Compliance Officer Jessica Mayer.

Get the full story at our sister site, Pharmaceutical Processing World.

Creating Safe Usable Medical Device Solutions: Free webinar from MedAcuity and Fathom Consulting

Panelist Mary Donnelly from Fathom Consulting [Photo via Fathom Consulting]

MedAcuity — a Boston-based software development partner for medical device makers — and Minneapolis-based Fathom Consulting are offering a free webinar exploring “the importance of design and development collaboration to keep projects on time and on budget.”

The four panelists — Mary Donnelly and Elizabeth Sipple from Fathom and Bruce Johnston and Mike Kropp from MedAcuity — will discuss why and how collaboration is essential for innovation, usability and safety in medical device interfaces.

Registration for the Sept. 15 webinar is free of charge.

Topics addressed will include: breaking down communication barriers; putting users first coupled with safety and reliability; why to prototype; when to user test; avoiding FDA pushback due to poor UI/UX design; meeting business objectives; and ensuring reasonable development effo…

Steris launches new cleanroom disinfectant wipes

Steris Vesta-Syde disinfectant wipes (Photo courtesy of Steris)

Steris Life Sciences has launched a new disinfectant wipe for cleanroom surfaces.

The new Vesta-Syde SQ 64 sterile wipes are packaged with a separate, internal pouch that contains the active ingredient, quaternary ammonium.

The internal pouch design “allows for maximum chemical stability while offering a simple, convenient, and consistent method to saturate the wipes,” Steris (NYSE:STE) said in a news release. “By simply rolling the package of wipes, the internal pouch of liquid opens and quickly saturates the wipes … with minimal preparation effort.”

Each package of the low-linting, knitted polyester wipes is double-bagged and gamma-irradiated for cleanroom users, offering sterility testing with lot traceability for quality assurance and quality control.

Medtronic builds suspense for renal denervation study results

Medtronic’s Symplicity Spyral renal denervation system delivers energy to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]

Medtronic’s clinical study of its Symplicity Spyral renal denervation system for hypertension is likely to go down to the wire for inclusion as a late-breaking clinical trial at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) conference.

The highly anticipated results will offer new insight into the Fridley, Minnesota-based medical device manufacturer’s quest to build a billion-dollar business treating hypertension. CEO Geoff Martha recently reported “good progress” in those efforts, saying the trial “represents the final piece of a large body of evidence that we intend to submit to the FDA for approval.”

Medtronic (NYSE:MDT) said it still hopes to present results of its Spyral HTN-ON MED trial at the Cardiovascul…

FDA outlines COVID-19 vaccine review plan for children

[Photo by Eugene Chystiakov]

FDA leaders have issued a statement regarding the agency’s plan moving forward with regards to authorizing COVID-19 vaccines for children.

The FDA plans to “follow the science” with eyes on COVID-19 vaccines for children younger than 12 as schools begin to get back in session around the country, the agency said in a news release attributed to acting Commissioner Dr. Janet Woodcock and Dr. Peter Marks, director of the FDA’s Center for Biologics Research and Evaluation.

Get the full story at our sister site, Drug Discovery & Development.

ResMed touts study demonstrating impact of CPAP on chances of living longer

Image from ResMed

ResMed (NYSE:RMD) is touting data highlighting the use of PAP therapy and its connection to potentially living longer.

A late-breaking abstract presented at the virtual European Respiratory Society (ERS) International Congress 2021, supported by ResMed, found that using positive airway pressure (PAP) therapy as directed can significantly increase sleep apnea patients’ chances of living longer, according to a news release.

Get the full story at our sister site, MassDevice.

Novocure wins FDA breakthough designation for liver tumor treatment device

Novocure (NSDQ:NVCR) announced today that the FDA granted breakthrough designation for its NovoTTF-200T liver cancer treatment system.

St. Helier, Jersey-based Novocure designed its NovoTTF-200T system, a tumor treating fields (TTFields) delivery system for use in tandem with atezolizumab and bevacizumab for the first-line treatment of patients with unresectable or metastatic liver cancer.

According to a news release, the FDA granted breakthrough device designation based on clinical data from Novocure’s Phase 2 pilot Hepanova trial evaluating the safety and efficacy of TTFields together with sorafenib for treating advanced liver cancer.

Get the full story on our sister site, MassDevice.