Boston Scientific wins FDA nod for intravascular ultrasound system

The Avvigo multi-modality guidance system. [Image courtesy of Boston Scientific]Boston Scientific (NYSE: BSX) + announced today that the FDA cleared its Avvigo+ multi-modality guidance system.

The next-generation system provides intravascular ultrasound (IVUS) and fractional flow reserve (FFR). It uses advanced software and hardware to provide high-quality IVUS vessel imaging and physiology experience. The system’s uses include percutaneous coronary intervention (PCI) procedures.

Boston Scientific’s PCI business continues to grow, particularly in China. The company touched on that and much more at its Investor Day last week — read more here.

Building upon the company’s Avvigo guidance system II, the technology helps to inform treatment decisions. It enables faster, more efficient procedures, such as angioplasties and atherectomies for patients with coronary artery disea…

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Know Labs prices $7M public offering

The Gen 1 prototype device. [Image courtesy of Know Labs]Know Labs (NYSE:KNW) announced today that it priced an underwritten public offering worth about $7 million in proceeds.

Seattle-based Know Labs, which develops a non-invasive glucose monitor, is offering 28 million shares of common stock. It priced the offering at 25¢ per share, with aggregate gross proceeds expected to total $7 million.

The company expects the offering to close on or about Sept. 29, subject to customary closing conditions. Know Labs also granted underwriters a 30-day option to purchase up to 4.2 million additional shares of common stock. Those shares cover over-allotments at the 25¢ per share public offering price.

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

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NIH to locate ARPA-H’s Catalyst Hub in Massachusetts

An agency within the National Institutes of Health (NIH) tabbed Massachusetts as the host of its Investor Catalyst Hub.

The federal Advanced Research Projects Agency for Health (ARPA-H) selected Massachusetts as the hub. It supports ARPA-H’s mission to foster collaboration among researchers, entrepreneurs and investors. The agency aims to accelerate innovative ideas that transform healthcare.

In a press briefing, ARPA-H Director Dr. Renee Wegrzyn announced the selection of Massachusetts. This formally launched ARPANET-H, a nationwide health innovation network comprised of three hubs across the U.S. ARPA-H chose Hadley, Massachusetts-based VentureWell to run and manage the Massachusetts-based hub. It will focus on helping the agency navigate the business and regulatory landscape and provide resources to bring ideas to market.

“This is a huge win for Massachusetts and an opportunity to bring economic development while strengthening our role as a nati…

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Onward announces first-in-human implant of stimulator with BCI

The Onward ARC-IM neurostimulation device. [Image courtesy of Onward]Onward Medical announced today that it completed the first-in-human implant of its ARC-IM stimulator for restoring upper extremity function.

Eindhoven, The Netherlands-based Onward designed the stimulator to restore function after spinal cord injury (SCI). The patient also received a wireless brain-computer interface (BCI) for initiating thought-driven movement when paired with ARC-IM.

Onward’s ARC-IM delivers targeted, programmed therapy to the spinal cord to restore movement and other functions after SCI. Multiple feasibility studies demonstrated restored mobility and stabilized blood pressure with the device.

Last month, Dr. Jocelyne Bloch performed two procedures at Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland. The ARC-IM implant took place on Aug. 14 and Bloch implanted the WImagine BCI from CEA-Clinatec nine days later.

The BCI works …

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Report: Edwards is cooperating with EU amid antitrust scrutiny

According to reports, Edwards Lifesciences (NYSE: EW) + is the company under scrutiny in Europe for potential antitrust activity.

Reuters reports that the company is working with EU antitrust regulators on the matter. The European Commission said last week that it conducted a surprise inspection at an undisclosed medtech company. It listed that company as active in the cardiovascular space, an area in which Edwards operates. Edwards is one of the market leaders in replacement heart valves, including transcatheter aortic valve replacement (TAVR) technology.

The report says Edwards confirmed itself to Reuters as the company inspected by the European officials. Edwards’ statement to the outlet said it is cooperating with the European Commission and remains confident in its business practices. The company also reportedly told Reuters that it remains committed to healthy, fair competition.

According to a news r…

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Fast Five: ZimVie wins FDA IDE for Mobi-C study, Moon Surgical announces first clinical cases with surgical robot

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, September 27, 2023.

Fast Five by MassDevice · ZimVie wins FDA IDE for Mobi-C study, Moon Surgical's first U.S. clinical cases with surgical robot

Senseonics this week announced it completed a 365-day CGM study cohort. Fast Five hosts Sean Whooley and Danielle Kirsh explain what the study evaluated and what were some of the most important results from that study. Read more here>>

iRhythm has launched its next-generation Zio monitor that has enhanced long-term monitoring. Hear some of the details about Zio and the company’s launch strategy. Read more here>>

MMI has announced that its surgical robot has surpassed 500 clinical cases. Whooley details the surgical robot, what kind of regulatory backing it has and how some of the procedures went. Rea…

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Galen Robotics wins FDA de novo nod for ear, nose, throat surgical robot

[Image from the Galen Robotics website]Galen Robotics announced today that the FDA granted it de novo classification for its Galen ES robotic surgery system.

The de novo nod authorizes the use of Galen ES in rigid microlaryngeal procedures.

Baltimore-based Galen Robotics designed the system as a cooperatively powered surgical assistant for ear, nose and throat (ENT) surgery. It facilitates ENT procedures, including instrument placement, in conjunction with microlaryngeal alligator forceps.

According to a news release, the device works in tandem with surgeons’ movements. It assists with the precise and stable positioning of an instrument while maintaining direct physical control.

“Our team is incredibly proud the Galen ES Robotic System was granted FDA clearance in record time,” said Bruce Lichorowic, president & CEO of Galen Robotics. “With our de novo granted, Galen looks forward to further advancing the field of surgical…

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Siemens Healthineers’ Varian acquires oncology solutions company Aspekt Solutions

Varian, a Siemens Healthineers company, announced today that it acquired oncology solutions provider Aspekt Solutions.

Aspekt Solutions provides medical physics, dosimetry and strategy consultation services. The acquisition aims to expand Varian’s advanced oncology solutions (AOS) offerings. Palo Alto, California-based Varian wants to increase the ability to address the rising demand for customized services and standardized care.

Varian provides support for every step of the chance care journey, from screening to survivorship. Its offerings include imaging and radiation therapy, plus software and services and interventional radiology.

Through AOS, Varian offers tailored engagements harnessing technology and combining it with professional support. These support teams collaborate with cancer centers to realize their unique goals. The company says it helps them expand, upgrade or standardize operations while implementing global best practices in cance…

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Exactech promotes from within to fill CEO spot

New CEO Darin Johnson. [Image courtesy of Exactech]Exactech announced today that it promoted Darin Johnson, the company’s president, to the position of CEO.

Johnson took over as interim CEO for the Gainesville, Florida-based orthopedic implant maker in March 2023. He now succeeds Jeffrey Binder, chair of Exactech’s board of directors.

Since joining Exactech in 2002, Johnson has held a number of executive-level leadership roles. As president, he oversaw all of the company’s business units, as well as human resources and information technologies functions. Before that, Johnson led the extremities business unit.

Over his stint at Exactech, Johnson’s experience includes building nad leading cross-functional, global teams. Those teams include orthopedic surgeons, product managers, engineers and sales professionals.

Binder highlighted Johnson’s “excellent job guiding Exactech over the past six months.” He cited yea…

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Covalon announces CEO departure, search for permanent replacement

Covalon Technologies (TSXV:COV) announced today that it named Amir Boloor as interim CEO following the departure of Brian Pedlar.

Boloor serves as chair of the company’s board. As he takes on an executive role, the board appointed Joseph Cordiano to serve as lead independent director.

Mississauga, Ontario-based Covalon commenced a search for a permanent CEO. Pedlar remains on the company’s board of directors.

“On behalf of the entire board, I would like to sincerely thank Brian for his leadership during his more than 13-year tenure, including the company’s evolution from a research and development-centric company to a product-centric company. He set the stage for Covalon’s next phase of growth,” said Boloor. “We look forward to receiving his continued advice and wish him much success in his future endeavors.”

Martin Goldfarb, board member and one of Covalon’s largest shareholders, said Boloor brings a “deep understanding…

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Senseonics completes 365-day CGM study cohort

The Eversense E3 system. [Image from Ascensia/Senseonics]Senseonics (NYSE:SENS) announced today that it completed its ENHANCE pivotal clinical study adult cohort for its 365-day Eversense CGM.

Germantown, Maryland-based Senseonics’ ENHANCE study recorded the completed 365-day visit for the final study patient. The study evaluates the year-long implantable continuous glucose monitor in adults. It also has a pediatric cohort (ages 14 to 18), which saw its first patient insertion in April.

ENHANCE evaluates the safety and accuracy of Eversense over one year. More than 165 adult subjects received Eversense insertions across four U.S. centers. The company completed enrollment in September 2022. Senseonics also used data from the study to support its FDA submission for integrated continuous glucose monitoring (iCGM) designation this year.

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

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First U.S. clinical cases performed with Moon Surgical’s Maestro surgical robot

The Maestro surgical robot. [Image courtesy of Moon Surgical]Moon Surgical announced today that a hospital in Florida performed the first U.S. clinical procedures with its Maestro surgical robot.

The procedures took place at Baptist Health in Jacksonville, Florida. Dr. Steven Hodgett, Dr. Craig Morgenthal and Dr. Alexander Rose performed the surgeries. They conducted sleeve gastrectomies, the most common bariatric (weight loss) surgery.

Moon Surgical’s latest U.S. milestone comes around nine months after it received FDA clearance for Maestro in December 2022.

“The Maestro System is an asset to my laparoscopy practice,” said Hodgett, medical director, Baptist Center for Bariatric and Reflux Surgery. “During procedures, the two co-manipulative arms provided me with stable vision and dependable organ retraction, allowing me to give more focus to my surgical case and perform at my best.”

More about Moon Surgical and Maestro

Paris-based Moon Surgica…

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