MassDevice Archives - Page 419 of 587 - Medical Design Sourcing

FDA rejects Verily’s smartwatch-based Parkinson’s exam

Verily’s Study Watch [Image courtesy of Verily]The FDA issued a letter to Google’s (NSDQ:GOOGL) Verily declaring that it will not accept a letter of intent for the company’s Parkinson’s exam.

Verily submitted the LOI for drug development tool (DDT) for the virtual motor exam for Parkinson’s disease. The device measures a change in digitally assessed parameters of a subset of Parkinson’s disease motor signs from the MDS-UPDRS Part III (motor examination) through a smartwatch (Verily’s Study Watch), according to the FDA letter.

The FDA determined that the examinations provided by Verily are “limited in their capacity to evaluate meaningful aspects of concepts of interest that are relevant to the patients’ ability to function in day-to-day life.”

In the letter, the FDA said a change in rigidity or finger tapping can’t be directly interpreted as meaningful to patients, while a change in speech, eating and dr…

Philips issues recall for foam component in some sleep and respiratory care devices

Royal Philips (NYSE:PHG) today provided an update on the recall for specific bi-level PAP and CPAP ventilator devices.

On April 26, Philips issued a recall notification for specific Philips bi-level positive airway pressure (bi-level PAP), continuous positive airway pressure (CPAP) and mechanical ventilator devices due to potential risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in the devices.

According to a news release, the majority of the affected devices within the advised five-year service life are in the first-generation DreamStation product family. The complaint rate registered at 0.03% in 2020, Philips said.

The Amsterdam-based company determined through testing that there are possible risks to users related to the PE-PUR sound abatement foam component, including the possibility of the foam degrading into particles that may enter the device’s air pathway and be ingested by the user.

Addition…

MedTech 100 roundup: Significant uptick for industry

The up-and-down nature of the medtech industry continues to carry through 2021, with a recent dip now followed by a rapid ascent.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the week (June 11) at 109.63 points, producing a 2.5% rise from the 106.96-point mark set one week prior (June 4).

It provides a welcome sight after the industry’s progress came to a halt with a -1.4% dip the week before last. The index remains in a position to produce another upswing after demonstrating signs of picking up again when April brought the industry’s all-time best performance.

Even with setbacks that slowed the industry recently, medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry has registered a 18.8% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus a 76.5% increase from the mid-pandemic low…

J&J must reportedly throw out 60M COVID-19 vaccine doses from Emergent plant

Another large amount of doses of Johnson & Johnson’s COVID-19 vaccine produced at an embattled manufacturing plant reportedly have to be thrown out.

The New York Times reported that the FDA told J&J that about 60 million doses of the single-dose vaccine produced at Emergent BioSolutions’ Baltimore plant can’t be used because of possible contamination.

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

TransMedics says FDA advisory committee will review its OCS Liver System in July

TransMedics (NSDQ:TMDX) announced that the FDA confirmed that it will review its premarket approval application next month.

Andover, Mass.-based TransMedics said the FDA scheduled a public advisory committee meeting to review the PMA application for the OCS Liver System, an organ transplant transportation platform, for July 14, 2021.

In the committee meeting, the FDA’s Gastroenterology & Urology Devices Panel of the Medical Devices Advisory Committee will discuss the platform, make recommendations and vote on a recommendation for approval of the OCS Liver System, according to a news release.

“We are looking forward to presenting the OCS Liver PROTECT data to the advisory committee panel in support of our PMA for the OCS Liver System,” TransMedics president & CEO Dr. Waleed Hassanein said in the release. “This is another important milestone to bring TransMedics closer to having all of our three organ platforms approved by F…

Martha sets 800 million patient mark for Medtronic

Can Medtronic really reach 10 times as many people as it does today?

In an interview with MedtronicTalks, Geoff Martha says one year in the CEO seat has shown him the company is positioned to have a far greater impact on global health than it currently does.

“We take great pride in that we impact the lives of two patients every second,” Martha said. “That sounds like a lot. Two patients every second adds up roughly to 80 million people per year. But … 80 million is just a small fraction of the world’s population. We tend to deal with the sicker people that need a cardiac device or a surgical procedure.”

Martha said with advances in miniaturization, artificial intelligence, longer battery life and other areas, Medtronic is positioned to develop products that help millions more.

“We should be much more ubiquitous given the advancements given advancements in technology and the role that we can play in healthcare,” Martha said. “I really think…

FDA Breakthrough Device Designation: What You Need to Know

The FDA Breakthrough Device Designation keeps you top of mind with the FDA, provides commercialization support, and gets attention from investors. For tips on how to apply, and how you can profit from breakthrough designation, get a copy of Avania’s latest white paper.

Download the white paper from Avania to learn more…

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Getinge adds AI to its OR management software

Getinge announced today that it launched the Torin AI-based operation room management system in the U.S.

Sweden-based Getinge’s Torin software uses AI to quickly and seamlessly improve the speed and efficiency of scheduling surgical procedures. The platform launched in 2020.

The company today introduced a new suite of advanced functions for the platform, expanding its capabilities in key areas, including predicting surgery times, managing waitlists and data security, according to a news release.

“The new capabilities now available with Torin are specifically designed to help hospitals and surgery centers address many areas that are major challenges, including accurate assessments of surgery times, scheduling and waitlist management, applications of mobile devices and data security requirements based on their specific pre-requisites,” Getinge VP of integrated workflow solutions Charlotte Enlund said in the release. “For long-term a…

Smart clothes powered by AI could monitor health

The fingertips of a wireless voltage detection glove illuminates when the wearer’s hand approaches a live cable. (Purdue University photo/Rebecca McElhoe)

Engineers at Purdue University are touting a method for turning cloth items into battery-free, wearable and wireless “smart clothes.”

The engineers at the West Lafayette, Ind.-based university developed a new spray/sewing method designed to transform any conventional cloth item into these smart clothes that can also be cleaned in the washing machine like normal clothing.

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

Biden to promise world 500 million COVID-19 vaccine doses

President Joe Biden [Image courtesy of the White House]President Joe Biden has struck a deal with Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) to provide 500 million COVID-19 vaccine doses to roughly 100 countries over two years.

The two companies today confirmed the news, saying that the U.S. government will purchase at a not-for-profit price 200 million doses in 2021 and 300 million in early 2022. Doses will go to 100 low- and lower-middle-income countries including those in the African Union via the COVAX Facility.

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

FDA approves Medtronic recharge-free spinal cord neurostim

[Image from Medtronic]Medtronic (NYSE:MDT) announced today that the FDA approved its Vanta recharge-free implantable neurostimulator (INS).

Fridley, Minn.-based Medtronic touts the Vanta INS as having a device life of up to 11 years, which stands as more than twice the device life of competitive primary cell devices, according to a news release.

Additionally, Vanta uses Medtronic’s proprietary AdaptiveStim technology that adapts to the patient’s movement or body position through a built-in accelerometer. The platform can automatically adjust stimulation to maintain each patient’s optimal dose.

Vanta represents a 10% increase in longevity when compared to Medtronic’s previous generation of recharge-free device, the PrimeAdvanced. Its design marks a 20% decrease in size compared to PrimeAdvanced, with a more rounded, ergonomic contouring for enhanced comfort, the medtech giant said.

The platform can access Medtronic’s pr…

Cardinal Health wins new FDA approval for Lymphoseek

Cardinal Health (NYSE:CAH) announced today that the FDA approved its Lymphoseek injection for pediatric use.

Dublin, Ohio-based Cardinal Health touts Lymphoseek, which it acquired from Navidea Biopharmaceuticals (NYSE:NAVB) in November 2016, as the first and only radiopharmaceutical agent specifically designed for targeted lymphatic mapping nad guiding sentinel lymph node biopsies (SLNB).

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