MassDevice Archives - Page 375 of 587 - Medical Design Sourcing

Former Boston Scientific executive Evan Brasington joins Perineologic

Corbin Clinical Resources’s Perineologic this week announced that it appointed Evan Brasington as chief commercial officer.

Brasington will be responsible for leading the Cumberland, Maryland-based company’s commercial strategy including operations, marketing, sales and distribution.

“We are very pleased to welcome Evan to the Perineologic team. He brings more than 30 years of leadership experience in the medical device sector, including planning and execution of global marketing and sales strategies to grow marketplace adoption of new technological solutions,” president and founder Matthew Allaway said in a news release. “Our company is dedicated to bringing patients a better, safer and more precise option for prostate biopsy, and Evan’s deep knowledge of the urology market will be invaluable in expanding adoption of the PrecisionPoint system in the years ahead.”

Prior to joining the company, Brasington held num…

FDA approves Transmedics’ OCS Liver preservation system

TransMedics (NSDQ:TMDX) today announced that it has received FDA premarket approval for its OCS Liver system for use with organs from donors after brain death and circulatory death.

Andover, Massachusetts-based Transmedics designed the device to preserve and monitor the hemodynamics and metabolic function to allow for ex-vivo assessment of liver allografts from brain dead and circulatory dead donor livers.

“We are extremely proud of this approval of our OCS Liver technology, as it represents the first and only liver perfusion technology to be approved by the FDA in the United States,” president and CEO Waleed Hassanein said in a news release. “TransMedics is now uniquely positioned to offer its OCS perfusion technology for lung, heart and liver transplantation. Our goal is to leverage these FDA approvals to make more donor organs available to help patients in need of the life-saving transplant procedure. We are looking forward to expanding our…

FDA clears BreatheSuite’s device to turn regular metered-dose inhalers into smart inhalers

BreatheSuite today announced that it has received FDA 510(k) clearance for its BreatheSuite metered-dose inhaler (MDI) V1 device.

BreatheSuite designed the device to turn existing MDIs into smart inhalers by automatically monitoring and providing feedback on inhaler adherence and technique for people with asthma and COPD. It has a disposable, battery-powered, portable MDI add-on and a mobile application that is based on behavior change strategies.

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

CDRH’s Shuren says they’re ‘starting to turn the corner’ from COVID-19

CDRH director Dr. Jeff Shuren [Image courtesy of FDA]Medical device industry insiders will have to wait until the new year to get a better idea of the post-pandemic priorities at the FDA’s CDRH.

That was one of the big takeaways from Dr. Jeff Shuren’s remarks at the virtual CDRH Town Hall held yesterday at AdvaMed’s The MedTech Conference, which takes place this week as a combination of virtual presentations and live presentations events in Washington, D.C., and Minneapolis.

Shuren, the director of FDA’s Center for Devices and Radiological Health, said the center is “starting to turn the corner” on catching up on submissions. Additional funding from Congress, he said, allowed CDRH to bring on more people, leverage contractors and make changes in policy and process.

Get the full story on our sister site Medical Design & Outsourcing.

Pfizer and BioNTech submit initial data to FDA on its COVID-19 vaccine and younger children

Pfizer-BioNTech

Pfizer (NYSE:PFE) and BioNTech (NSDQ: BNTX) plan to formally seek FDA emergency authorization in the coming weeks for the use of their Comirnaty (BNT162b2) vaccine in children 5 to 11.

The news came today as the companies announced the submission of initial Phase 2/3 trial data to FDA.

The companies last week announced that the vaccine had favorable immunogenicity and tolerability in children 5 to 11.

Vaccine recipients in the clinical trial received a 10-μg dose of mRNA, which is one-third of the amount the company had studied in 16 to 25 year-olds.

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

FDA clears Koya Medical’s active compression therapy on the go

Koya Medical said today that it has won FDA 510(k) clearance for its Dayspring Lite treatment for lymphedema and venous disease.

The Oakland, California–based company’s Dayspring family of treatments enables people to be mobile during active compression therapy — unlike traditional wall-tethered compression pumps.

Dayspring Lite is a prescription-only treatment for people who need basic active compression for their lymphedema regimen. It allows patients to select and monitor one of three standard treatment intensities through the Koya app. If the patient’s needs evolve to require calibration and additional customization, Koya Medical can help them transition to the more advanced Dayspring therapy.

“Managing chronic diseases like lymphedema, which often occurs as a result of cancer or cancer treatment, is a journey, and we know that needs can evolve throughout that journey,” Koya Medical founder and CEO Andy Doraiswamy said in a ne…

GE Healthcare launches next-gen fixed X-ray system

The Definium Tempo fixed X-ray system [Image courtesy of GE Healthcare]GE Healthcare (NYSE: GE) today announced its next-gen Definium Tempo fixed X-ray system.

The Definium Tempo is a fixed, overhead tube suspension (OTS) digital X-ray system. Its creators designed it to be a “personal assistant” to radiologists and technologists. The idea is to leverage automation to reduce workflow burdens and help radiology departments boost patient care.

The Definium Tempo’s tube-mounted console includes functionality for patient selection, protocol selection, technique modification and positioning setup — enabling a technologist to finish all exam setup and positioning without leaving the patient’s side. There are also automatic features, including Auto Positioning, Auto Centering and Auto Tracking.

“I’ve been a technologist for over 17 years, and using this system has been unlike anything I’ve experienced before – it’s a…

Medtronic wins CE mark approval for radial artery access portfolio

Medtronic today said it has received CE mark approval for its radial artery access portfolio.

The radial artery access devices include the Rist 079 radial access guide catheter and the Rist radial access selective catheter.

Medtronic designed the Rist 079 guide catheter to access the neuro vasculature through the radial artery instead of through the transfemoral artery.

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

Medtronic CFO offers supply chain update as medical device industry concerns mount

Medtronic CFO Karen Parkhill [Photo courtesy of Medtronic]Medtronic (NYSE:MDT) was among the participants in a White House semiconductor summit last week to address the continuing global shortage of electronic chips, but CFO Karen Parkhill says the world’s largest medical device manufacturer is not in same dire straits as chip buyers in other industries.

Medtronic’s supply chain is “holding up OK, but we’re seeing pressures like everybody else,” Parkhill said Friday in an interview with Medical Design & Outsourcing.

Get the full story at our sister site, Medical Design & Outsourcing.

Women may have more adverse events with left atrial appendage occlusion devices than men

Left atrial appendage occlusion (LAAO) devices on the market include Abbott’s Amplatzer Amulet (left) and Boston Scientific’s Watchman (right). [Images courtesy of Abbott and Boston Scientific]Women appear more likely than men to experience adverse events or lengthened hospital stays from left atrial appendage occlusion (LAAO) devices, the FDA announced today.

In a letter to health care providers, the FDA said researchers have yet to determine the reason for the difference — and that it is working with device makers to understand the cause.

Get the full story on our sister site Medical Design & Outsourcing.

Gottlieb: Delta wave could burn out by Thanksgiving

Scott Gottlieb

Pfizer board member Dr. Scott Gottlieb has predicted that the COVID-19 Delta surge could mark a high-water mark of the pandemic.

“This may be the last major wave of infection,” said Gottlieb, who served as the FDA commissioner from 2017 to 2019.

In an interview with CNN, Gottlieb predicted that the pandemic in the U.S. would transition from pandemic to endemic phase in the relatively near future.

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

Former Theranos lab director takes the stand, says Elizabeth Holmes was ‘nervous’ amid blood test inaccuracy concerns

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]A former Theranos lab director testified on Friday in the Elizabeth Holmes federal fraud trial that the company was aware of the multiple concerns raised by physicians and Theranos employees prior to the Walgreens launch.

Adam Rosendorff, a Theranos lab director from 2013 until late 2014, testified that Holmes and other top executives were pushing him to validate tests that he was not confident in, CNBC reports. The former lab director testified that he sent an email to Holmes in August 2013 that said that the blood-testing device was not ready for a launch in Walgreens stores. He also raised issues related to the training and staffing in the laboratory.

Rosendorff also spoke directly with Holmes, who had a countdown of the days until the Walgreens launch posted on her office window, regarding the concerns spe…