MassDevice Archives - Page 220 of 587 - Medical Design Sourcing

FDA clears Medtronic patient monitor for procedural sedation and medical-surgical units

[Image from Medtronic]Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for its RespArray patient monitor.

Fridley, Minnesota-based Medtronic designed RespArrayfor procedural sedation and medical-surgical units. It features Nellcor pulse oximetry and Microstream capnography.

RespArray also offers electrocardiogram (ECG), non-invasive blood pressure (NiBP) and temperature monitoring. Its smart algorithms help to detect respiratory compromise early and reduce alarm fatigue.

Medtronic said in a news release that it plans for a limited market release in the fourth quarter of 2022. A full-market release is earmarked for early 2023. The company said the system helps with the increased need for attention for patients in procedural sedation and medical-surgical units as staffing shortages and clinician burnout caused a decrease in patient safety.

According to Medtronic, improved continuous monitoring and response help to prevent 97% …

Evolent Health names Dan McCarthy as president

Evolent Health announced that it named Dan McCarthy as president of the company, effective Sept. 15, 2022.

Arlington, Virginia-based Evolent Health made the announcement on Sept. 1.

McCarthy, 38, held the role of New Century Health — a subsidiary of Evolent — from 2019. He will continue to serve in this role. Before his time at New Century Health, he served as SVP in partner development and as chief growth officer. He initially joined in 2014.

In connection with his promotion, McCarthy’s base salary increased to $460,000. He will be eligible for the company incentive plan with a target bonus of up to 175% of his base compensation. He will also be entitled to rewards under stock incentive plans. Evolent also announced that Frank Williams expressed his intent to not stand for re-election as director. He will continue to serve as director until the 2023 annual meeting, according to a news release. The company provides support leading providers and heal…

Philips Respironics issues updated instructions on CPAP, BiPAP masks

The Philips Amara View full face mask. It is one of the masks affected by the company warning.

Philips (NYSE:PHG) announced that its Respironics subsidiary warned users of certain therapy masks of potential issues with implanted devices.

The company alerted users of certain CPAP or BiPAP therapy masks with magnetic headgear clips or straps. Such devices should not be used by or near patients and their household members, caregivers and bed partners who have metallic implanted devices or metallic objects (such as metallic splinters) in the body.

Philips said the magnetic headgear clips attach headgear straps to the masks. The company noted that this is a “commonly used” method in the sleep therapy devices industry.

This represents the latest addition to the mounting troubles for Philips Respironics. The company has been dealing with a massive recall of CPAP and BiPAP ventilators and other respiratory devices and has been in talks with federal p…

CVS Health to buy Signify Health for $8B

CVS Health (NYSE:CVS) announced that it entered into an agreement to acquire Signify Health for approximately $8 billion.

Home healthcare services company Signify Health offers clinical, social, and behavioral services to support value-based healthcare. It provides a mobile network of 10,000 credentialed clinicians who offer in-home evaluations of Medicare Advantage and Medicaid plan members.

CVS said in a news release that Signify Health’s clinicians and providers will engage with CVS Health’s collection of assets, connecting patients to care how and when they need it.

“Signify Health will play a critical role in advancing our health care services strategy and gives us a platform to accelerate our growth in value-based care,” said CVS Health President and CEO, Karen S. Lynch. “This acquisition will enhance our connection to consumers in the home and enables providers to better address patient needs as we execute our vision …

Medtech executive convicted of COVID-19 tests fraud

A federal jury convicted the president of a medtech company — Arrayit — accused of participating in a scheme to mislead investors over COVID-19 tests.

In June 2020, the U.S. Department of Justice (DOJ) charged Arrayit president March Schena for alleged involvement with fraudulent claims for allergy and COVID-19 testing. The charges alleged a scheme to mislead investors, commit health care fraud, and pay illegal kickbacks in connection with the submission of over $77 million in false and fraudulent claims for COVID-19 and allergy testing.

Schena, 59, engaged in a scheme to defraud Arrayit’s investors, according to court documents and evidence presented at trial. He allegedly claimed he invented revolutionary technology to test for virtually any disease using just a few drops of blood.

In a 2020 affidavit in support of the claim, Schena claimed that Sunnyvale, Calif–-based Arrayit was the only laboratory in the world offering microarray technology th…

J&J’s Biosense Webster launches mapping catheter for cardiac arrhythmias

[Image from Biosense Webster]Johnson & Johnson’s Biosense Webster announced today that it launched the Octaray mapping catheter with TRUEref technology.

Irvine, California-based Biosense Webster designed Octaray for mapping cardiac arrhythmias, including AFib. It is powered by the company’s Carto 3 Version 7 system.

Get the full story at our sister site, Medical Tubing & Extrusion.

FDA clears neuromod system for treating depression from Magnus Medical

[Image from Magnus Medical]Magnus Medical announced today that it received FDA 510(k) clearance for its Saint neuromodulation system.

Burlingame, California-based Magnus designed Saint for the treatment of major depressive disorder (MDD). It treats adults who fail to achieve satisfactory improvement from prior antidepressant medications in the current episode.

The individualized, rapid-acting, non-invasive neurostimulation platform demonstrated the potential to be a reproducible, rapid and highly effective treatment for severe, refractory depression in a broader clinical setting. It received FDA breakthrough device designation in October 2021.

Saint combines advanced imaging technologies and personalized targeting and novel stimulation patterns. It uses structural and functional MRI to inform a proprietary algorithm. The algorithm identifies the optimal anatomic target for focused neurostimulation in people with MDD.

Results of a trial published in t…

MiMedx CEO is leaving, interim replacement named

Timothy Wright

MiMedx (Nasdaq:MDXG) announced today that Timothy Wright will depart as CEO with board member K. Todd Newton set to serve in an interim role.

Wright served as MiMedx’s CEO since May 2019. Newton holds the interim position while the company’s board appointed a special committee to conduct a search for a new CEO.

The search committee includes chairperson M. Kathleen Behrens, as well as James Bierman and William A. Hawkins III. MiMedx will retain an executive search firm to support the process, too.

“On behalf of the entire MiMedx board of directors, I thank Tim for his contributions during an important time in MiMedx’s history and wish him all the best in his future endeavors,” Behrens said in a news release. “As we work to accelerate our performance, renew our focus on execution and capitalize on the significant opportunity within our wound care & surgical and regenerative medicine & biologics Innovatio…

Neuspera Medical appoints new CEO

Implantable neuromodulation technology developer Neuspera Medical announced today that Steffen Hovard joined the company as CEO.

Hovard most recently served as president of Coloplast’s interventional urology arm. He had leadership responsibilities across four business areas within urological devices. At Coloplast, he oversaw 900 employees across 19 countries.

According to a news release, Hovard also serves as a board member for a number of medical device companies.

“I am delighted to have Steffen join and lead Neuspera as we look to bring our therapy platform to patients struggling with debilitating conditions such as UUI [urinary urgency incontinence],” said Mudit Jain of Treo Ventures, an investor in Neuspera. “He is an accomplished executive with an impressive record of leading multiple functions and driving significant growth in the urology space.”

Hovard joins just after Neuspera began enrollment for the second p…

Study backs RejuvenAir treatment for bronchitis from CSA Medical

CSA Medical announced today that study data support the use of its RejuvenAir system for treating chronic bronchitis.

Boston-based CSA Medical designed its metered cryospray (MCS) treatment using the RejuvenAir System. RejuvenAir, a proprietary interventional liquid nitrogen spray cryotherapy system, utilize software-driven dosimetry and specialty catheter.

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

European Commission blocks Illumina’s Grail acquisition, company to appeal

Illumina (Nasdaq:ILMN) announced today that the European Commission issued a decision prohibiting its planned acquisition of Grail.

San Diego-based Illumina said it is reviewing the order and intends to appeal the decision. The new hurdle in Europe follows last week’s U.S. Federal Trade Commission ruling in favor of the acquisition moving forward. An administrative law judge in the U.S. rejected the FTC’s argument that the $8 billion acquisition of Grail is anti-competitive.

The much-scrutinized acquisition of Grail, a cancer detection technology developer, has met a series of roadblocks along the way. In September 2020, Illumina agreed to acquire Grail, a startup that initially spun out from the company in 2016.

Illumina completed the acquisition in August 2021. However, Illumina agreed to hold Grail as a separate company as the European Commission conducted a regulatory review. Illumina argued Grail has no business in Europe. The company said the…

FDA approves expanded label for Boston Scientific Watchman FLX

The Watchman FLX [Image from Boston Scientific]Boston Scientific (NYSE:BSX) announced today that the FDA approved expanded labeling for its Watchman FLX LAAC device for stroke prevention.

The approval includes labeling with a 45-day dual anti-platelet therapy (DAPT) option for the left atrial appendage closure device (LAAC). DAPT represents an alternative to 45-day oral anticoagulation (OAC) plus aspirin for post-procedural treatment of non-valvular atrial fibrillation (NVAF) patients.

Dr. Ian Meredith, global CMO for Boston Scientific, said in a news release that the approval represents a significant step forward. “This revised labeling provides physicians more flexibility to exercise their clinical judgment based on individual patient characteristics to determine the most appropriate post-procedural antithrombotic medication regimen.”

Meredith added that the legacy Watchman and current-generation Watchman FLX tech’s robust safety and eff…