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Fast Five: Former Stimwave CEO convicted of healthcare fraud; GE HealthCare establishes foundation to advance access to care

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, March 14, 2024.

Fast Five by MassDevice · Former Stimwave CEO convicted of healthcare fraud; GE HealthCare establishes charitable foundation

Sooma raised $5.5 million for its depression-treating neuromodulation technology. Fast Five hosts Sean Whooley and Danielle Kirsh talk about what the company’s technology does and what it plans are for the funds.

SetPoint Medical won FDA breakthrough designation for its nerve stimulation technology for multiple sclerosis. Hear more about the technology and the executives’ optimism about the future of the technology.

Abbott is launching its latest Navitor TAVI system in the U.S. Whooley talks about the technology and Abbott’s TAVR market history.

GE Healthcare has established a foundation to advance acce…

Edwards reports ‘excellent’ outcomes with Sapien TAVR

The Sapien 3 transcatheter heart valve (Image from Edwards Lifesciences)

Edwards Lifesciences (NYSE: EW) + announced positive results from two real-world studies evaluating its Sapien transcatheter aortic valve replacement (TAVR) system.

Results came from the TVT Registry data and continued to demonstrate strong outcomes. Edwards presented the data at Cardiovascular Research Technologies (CRT) 2024.

A study of the latest TAVR technology, the Sapien 3 Ultra Resilia valve found lower rates of paravalvular leak (PVL) at 30 days when compared to the Sapien 3 and Sapien 3 Ultra valves. Results also showed lower echo-derived gradients and larger effective orifice areas across all valve sizes.

Edwards’ second study showed that its small Sapien TAVR valves demonstrate equal outcomes at three years compared to larger Sapien valve sizes.

“These real-world data further add to the robust body of evidence on the…

Former Stimwave CEO convicted of healthcare fraud

The U.S. Justice Dept. announced last week that a jury found former Stimwave CEO Laura Perryman guilty of healthcare fraud.

Damian Williams, U.S. Attorney for the Southern District of New York, last week announced the jury’s verdict. It found Perryman guilty on two counts of an indictment charging her with conspiracy to commit healthcare fraud and wire fraud and substantive healthcare fraud.

The jury convicted her of one count of healthcare fraud, which carries a maximum sentence of 10 years in prison. It also found her guilty of one count of conspiracy to commit healthcare fraud and wire fraud. That carries a maximum sentence of 20 years. The actual sentencing remains to be determined by the judge, DOJ said.

This verdict marks the latest development in a long-running case against Perryman. She founded and served as CEO of Florida-based Stimwave until her termination in 2019. The issues stem from the creation and sale of a fake medical device compo…

Abbott is launching its latest Navitor TAVI system in the U.S.

A screengrab of the Navitor Vision TAVI system from an Abbott video on LinkedIn. [Image from Chris Waddell on LinkedIn]Abbott (NYSE: ABT) + is launching the latest generation of its Navitor heart valve technology in the U.S., according to one company official.

In a post on LinkedIn, Chris Waddell, Abbott’s U.S. VP for transcatheter aortic valve implantation (TAVI), shared the news of the launch. The latest version — called the Navitor Vision — features a range of enhancements compared to the previous version.

“I’m excited to share Abbott is launching the latest generation of Navitor in the U.S.-Navitor Vision,” Waddell wrote in the post. “Abbott is going big in TAVI!”

Waddell shared that the features include stable and precise delivery, excellent hemodynamics and low paravalvular leak (PVL) rates. Abbott built the system upon a proven, durable platform with a future-ready design,…

BD names new president of BD Surgery

President of BD Surgery Rian Seger [Image courtesy of BD]BD this week announced it appointed Rian Seger as president of BD Surgery, effective April 1.

Seger will be responsible for driving the global strategic, operational and commercial performance of BD Surgery and will report to EVP and President of Interventional Rick Byrd. He replaces Brooke Story who is stepping down to focus on personal matters.

Before becoming president of BD Surgery, Seger was VP and general manager of BD’s Medication Delivery Solutions business unit within the BD Medical segment.

“Rian has more than 20 years of executive experience with proven leadership capabilities that help address unmet needs in health care,” Byrd said in a news release. “Re-joining BD Surgery strongly aligns with Rian’s passion for driving better outcomes for surgeons and patients. With his wealth of experience and a proven track record of delivering results and developing teams, he will be well-suited …

Inari Medical has positive ClotTriever data

The ClotTriever system. [Image from the Inari Medical website]Inari Medical (Nasdaq: NARI) + announced positive two-year interim results from the CLOUT registry evaluating its ClotTriever system.

Principal investigator Dr. David Dexter of Sentara Vascular Specialists in Norfolk, Virginia, presented the data at the American Venous Forum.

Results represent the largest prospective, multi-center, two-year dataset in deep-vein thrombosis (DVT) since the ATTRACT trial, Inari said in a news release. Data demonstrates the safety, effectiveness and long-term outcomes of ClotTriever in real-world DVT patients.

Inari designed ClotTriever to capture and remove large clot burden from big vessels. Treating patients in one single session, it eliminates the need for thrombolytic and a stay in the intensive care unit. The company hopes to make it the standard of care for DVT patients.

Patients showed a low incidence of indep…

SetPoint Medical wins FDA breakthrough nod for nerve stim tech for multiple sclerosis

[Image from the SetPoint Medical website]SetPoint Medical announced today that received FDA breakthrough device designation for its novel neuroimmune modulation platform.

Valencia, California–based SetPoint designed its nerve modulation technology for people with relapsing-remitting multiple sclerosis (RRMS). Breakthrough designation enables more communication and priority regulatory review with the FDA. Plus, it supports reimbursement and patient access upon approval.

This isn’t the first breakthrough nod for SetPoint’s technology. It picked up the designation in 2020 to treat rheumatoid arthritis (RA). The company continues evaluating the investigational platform in a pivotal clinical trial for the treatment of RA.

However, the latest breakthrough nod helps the company explore the technology for yet another condition. SetPoint’s platform features a miniaturized stimulation device placed on the vagus nerve. Once placed through a small inc…

GE HealthCare establishes foundation to advance access to care

GE HealthCare (Nasdaq: GEHC) + today announced the formation of a philanthropic entity to focus on advancing equitable access to healthcare.

The company established the GE HealthCare Foundation as a charitable organization, incorporated separately from GE HealthCare itself. It supports nonprofit organizations hoping to make healthcare more accessible, personal, human and flexible.

Ultimately, according to a news release, the Foundation wants to remove barriers blocking underserved communities from care. Its initial focus centers on improving maternal health outcomes around the globe.

“The GE HealthCare Foundation was born out of GE HealthCare’s legacy of delivering access to care, and a desire to advance health equity by reducing the limits and barriers faced by those in underserved communities,” said Danielle Halstrom, president of the GE HealthCare Foundation. “When we looked at where we could focus the Founda…

Fast Five: Recall of Abbott HeartMate comms system is Class I; Roman to move out of CEO post at 3M, successor named

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, March 13, 2024.

Fast Five by MassDevice · Recall of Abbott HeartMate comms system is Class I; Roman to move out of CEO post at 3M

GE HealthCare and Mass General are bringing artificial intelligence to imaging. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the partnership and how it can transform healthcare.

Ascensia and Senseonics have announced new CGM cost savings. Hear more about some of the cost saving initiatives and the devices that are included in the initiatives.

SS Innovations has used its surgical robot in mitral valve replacement procedures. Whooley talks about what the robot does and what people think about its performance.

3M CEO Mike Roman is stepping down as CEO and a successor has been named. Learn who is taking over the corner offic…

Sooma raises $5.5M for depression-treating neuromod

A patient uses the tDCS therapy at home. [Image courtesy of Sooma Medical]Sooma Medical announced today that it raised €5 million ($5.5 million) to support its at-home brain stimulation technology.

Nordic early-stage investor, Voima Ventures, led the funding round. Singapore-based Verge HealthTech Fund and existing investor Stephen Industries also participated. The funding marks a new phase of growth for Sooma in its mission, the company said in a news release.

Helsinki, Finland-based Sooma develops a flexible and accessible treatment solution called transcranial direct current stimulation (tDCS). Using a portable neuromodulation device, tDCS delivers a mild electrical current to stimulate the brain. Sooma designed it to alleviate depression symptoms without the need for pharmaceuticals.

Sooma’s treatment targets the brain and relieves symptoms without causing systemic side effects associated with antidepressants. The prescription-only therapies can p…

Ascensia, Senseonics announce new CGM cost savings

The Eversense E3 system. [Image from Ascensia/Senseonics]Ascensia Diabetes Care and Senseonics today announced an extension to their Eversense Payment Assistance and Simple Savings (PASS) program.

The program aims to help people in the U.S. access the Eversense E3 continuous glucose monitor (CGM) more affordably. It offers major savings for eligible individuals looking to experience the benefits of the long-term, implantable CGM.

Eversense E3, a 180-day CGM, requires two sensor insertion and removal procedures per year. It offers a mean absolute relative difference (MARD — an accuracy metric for CGMs) of 8.5%. The system features predictive on-body alerts to never miss a critical event. Senseonics develops the sensor and Ascensia serves as the global exclusive distributor for Eversense E3.

Senseonics also has the regulatory wheels in motion for Eversense E3 with a 365-day wear time. The company expects an “imminent” submission to the FDA.

GE HealthCare, Mass General bring AI to imaging

GE HealthCare (Nasdaq: GEHC) + announced today that it plans to expand its AI partnership with Mass General Brigham.

The two began work on AI solutions after announcing a 10-year commitment in 2017. They set out to explore AI across a broad range of diagnostic and treatment paradigms through sustainable AI development.

In September, they announced an effort to co-develop an AI algorithm to increase operations effectiveness and productivity. Today’s announcement highlights a plan to integrate medical imaging foundation model into their AI research work. The partnership also features a strong focus on responsible AI practices.

Dr. Keith Dreyer, Mass General Brigham’s chief data science officer, said the “next wave of AI innovation” already reshaped the building, integration and use of AI. Dreyer says GE HealthCare and Mass General already helped accelerate the introduction of AI into a rang…