Vicarious Surgical still expects to submit surgical robot to FDA in 2026

The Beta 2 surgical robotics system. [Image courtesy of Vicarious Surgical]Vicarious Surgical (NYSE:RBOT) management offered an update on the development timeline of its surgical robot as part of its fourth-quarter earnings.

Previous expectations earmarked mid-2024 for first-in-human trials and fiscal 2025 for de novo clearance submission. However, CEO Adam Sachs pushed V1.0’s timeline back in November 2023. The company outlined plans for a build and integration in fall 2024. Then, he earmarked early- to mid- 2026 for that de novo submission.

BTIG analyst Ryan Zimmerman issued a report noting that the company maintained its expectations for the robot’s regulatory submission. It still plans to have its Version 1.0 (V1.0) system ready for an FDA submission by early- to mid-fiscal 2026. Zimmerman said the company expects to begin cadaveric testing in the spring ahead of final software and hardware refinements. Integration remains on track for the fall. Read more

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Vicarious Surgical picks former Olympus exec as president

Vicarious Surgical President Randy Clark [Image courtesy of Clark’s LinkedIn page]Vicarious Surgical (NYSE:RBOT) announced that it appointed Randy Clark as its new president, effective today, Jan. 29.

The Waltham, Massachusetts-based surgical robot developer established the new role as it prepares for its next phase of growth. This role aims to fortify organizational alignment and focus on the company’s long-term needs and objectives.

Clark reports to CEO Adam Sachs and assumes responsibility for the day-to-day oversight of core business functions. Those include product development, operations, commercial strategy, clinical, regulatory and quality affairs and human resources.

The appointment comes as Vicarious prepares to finalize Version 1.0 of its surgical robotic system.

“We are thrilled to announce Randy’s addition to the Vicarious Surgical team, especially during this pivotal phase for the company as we approach the final…

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Vicarious Surgical has more layoffs, pushes back regulatory timeline for surgical robot

[Beta 2 surgical robotics system image courtesy of Vicarious Surgical]Vicarious Surgical (NYSE:RBOT) pushed back expectations on the timeline for its surgical robot as it trimmed its headcount for the second time this year.

Shares of RBOt fell 10.1% at 35¢ apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose nearly 2%.

In April, Vicarious completed a design freeze for its Version 1.0 (V1.0) surgical robotic system. The company said in its second-quarter earnings results that it planned for integration and the build of system units for this fall. Having received some input from the FDA, Vicarious Surgical had expectations to begin first-in-human trials in mid-2024. The company then planned to file for de novo clearance in fiscal 2025.

However, in the company’s third-quarter earnings results, co-founder and CEO Adam Sachs outlined a new timeline f…

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Vicarious Surgical faces NYSE delisting

[Beta 2 surgical robotics system image courtesy of Vicarious Surgical]Vicarious Surgical (NYSE:RBOT) announced that it received a notice regarding its compliance with the New York Stock Exchange (NYSE).

The Waltham, Massachusetts-based surgical robot maker received the notice on Sept. 20. It alerted the company that it is not in compliance with Section 802.01C of the NYSE Listed Company Manual. Vicarious Surgical’s average closing price of Class A common stock fell below $1 per share over a consecutive 30-trading-day period.

Vicarious said in a news release that the notice does not result in immediate delisting from the NYSE. It intends to respond to the exchange within 10 business days of receipt of the notice. The company said it intends to cure the stock price deficiency and return to compliance.

Adam Sachs, Vicarious Surgical CEO, will speak on a panel at DeviceTalks West next month. Learn more at<…

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Two-armed surgical robot prototype targets pediatric brain tumors

The endoscopic brain robot’s arms are each 2.8 mm in diameter and 35 mm long when fully extended. Together, they offer a 43 mm diameter workspace. [Image courtesy of Boston Children’s Hospital]

Researchers say they’ve developed a surgical robot for removing brain tumors in children, and that it could also offer a less invasive, safer option for adult neurosurgery and other procedures.

The trick is using hollow, nitinol robot arms to allow neurosurgeons to swap tools during a tumor resection procedure, said Pierre DuPont. He’s the chief of pediatric cardiac bioengineering at Boston Children’s Hospital, and the corresponding author of a new research paper detailing the potential advantages of a two-armed neuroendoscopic robot.

In an interview with Medical Design & Outsourcing, DuPont traced the project back to conversations with Dr. Jim Drake, chief of neurosurgery at Sick…

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Vicarious Surgical announces a new hospital system partnership

[Beta 2 surgical robotics system image courtesy of Vicarious Surgical]Vicarious Surgical (NYSE:RBOT) announced today that it signed a strategic development agreement with Intermountain Health.

Intermountain, a leading nonprofit healthcare system, features 33 hospitals, 385 clinics and 4,300 employed physicians in the U.S. Its more than one million members range across locations in Utah (headquarters), Colorado, Idaho, Kansas, Montana and Nevada.

Waltham, Massachusetts-based Vicarious said its agreement offers it access to the Intermountain Health network. It plans to collaborate directly with the system’s team of experienced robotic surgeons and integrated, managed-care business. The partnership leverages Intermountain’s expertise to identify and evaluate drivers of adoption, implementation and utilization of the Vicarious Surgical robotic system. It also aims to assess the potential for clinical outcome improvements and administrative efficiencies in …

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Vicarious Surgical looks to raise $45M from public offering

[Beta 2 surgical robotics system image courtesy of Vicarious Surgical]Vicarious Surgical (NYSE:RBOT) announced that it priced an underwritten public offering worth approximately $45 million in proceeds.

Waltham, Massachusetts–based Vicarious’ offering includes 45 million shares of its Class A common stock priced at $1 per share. Additionally, the company granted underwriters a 30-day option to purchase up to an additional 6.75 million shares of common stock.

Before deducting discounts, commissions and expenses, Vicarious expects $45 million in proceeds, assuming no exercise of that option. The company expects the offering to close on or about Aug. 7, 2023, subject to customary closing conditions. Morgan Stanley & Co. LLC and Cowen and Company, LLC serve as joint book-running managers for the offering, according to a news release.

The surgical robot developer did not disclose its intended use of the proceeds. Vicarious Surgical’s approach uses prop…

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Vicarious Surgical plans for in-human surgical robot trials next year, posts Q2 EPS miss

[Beta 2 surgical robotics system image courtesy of Vicarious Surgical]Vicarious Surgical (NYSE:RBOT) shares dipped this morning on second-quarter results despite a positive update on its surgical robot.

Shares of RBOT fell 2.9% to $1.69 apiece in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — stayed even.

The company failed to beat Wall Street expectations but shared good news on the regulatory process for its surgical robot platform. Vicarious Surgical’s approach uses proprietary human-like surgical robots. It transports surgeons inside the patient to perform minimally invasive surgery.

In April, Vicarious completed a design freeze for its Version 1.0 (V1.0) system. Integration and the build of system units remain on track for fall 2023.

Having received some input from the FDA, Vicarious Surgical expects to begin first-in-human trials in mid-2024. The c…

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Q&A with John Mazzola, Vicarious Surgical’s first chief operations officer

Vicarious Surgical Chief Operating Officer John Mazzola [Photo courtesy of Vicarious Surgical]

Capping off a medtech career spanning more than three decades, John Mazzola had only been retired from Becton Dickinson for about a week when Vicarious Surgical co-founder and CEO Adam Sachs hired him to lead strategic manufacturing planning.

One year later, the surgical robotics developer has promoted Mazzola to the newly created position of chief operating officer, covering product development, manufacturing, supply chain, quality, clinical, regulatory, IT, people and culture.

Related: Surgical robotics trends and how to accelerate adoption

Mazzola spoke with Medical Design & Outsourcing about the latest from Waltham, Massachusetts-based Vicarous Surgical (NYSE: RBOT), its plans for manufacturing and outsourcing, the company’s recent layoffs and lessons learned about developing and launching …

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They said it at DeviceTalks Boston 2023

Medical device industry leaders from Boston Scientific, Abbott, ZimVie, Medtronic, Stryker and more met at DeviceTalks Boston to share lessons learned and their perspectives on industry trends, device design and medtech innovation.

BD Chair, CEO and President Tom Polen (right) at DeviceTalks Boston with DeviceTalks Editorial Director Tom Salemi [Photo by Jeff Pinette for Medical Design & Outsourcing]

Bidding farewell to DeviceTalks Boston 2023, we look back at an exceptional two-day medical device conference teeming with insights from over 100 top industry leaders.

These experts unfolded many complexities of the medtech industry in more than 35 sessions, walking attendees from the medical device product development continuum through the latest medical innovations and strategies to tackle regulatory challenges, prototyping, manufacturing, product launches and more.

Between the high-profile keynote int…

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Vicarious Surgical promotes John Mazzola to COO

[Image from John Mazzola on LinkedIn]Vicarious Surgical (NYSE:RBOT) announced that it promoted John Mazzola to the role of chief operating officer (COO).

Mazzola joined the Waltham, Massachusetts-based surgical robotics company in March 2022 as SVP of operations. He brings with him more than 35 years of experience in the medical device industry. That includes involvement in more than 25 medical device product launches, according to a news release.

Before joining Vicarious, Mazzola spent 13 years in senior executive roles and product development leadership positions at BD. That included serving as VP of operations for BD’s surgery business. There, he oversaw 10 manufacturing sites, a business planning and procurement organization, an advanced manufacturing engineering team and the business’ environmental health and safety responsibilities.

Over the past year, Mazzola led strategic manufacturing plans for the Vicarious Surgical robotic system. In …

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Layoffs in medtech: These companies recently reduced their workforce

[Image courtesy of Nastuh Abootalebi on Unsplash] The workforce reduction trend has swept the economy recently, and unfortunately, the medtech space is not immune to layoffs.

You’ve probably read about the ongoing layoffs sweeping the tech industry, media and more.

For instance, Yahoo, Disney, Zoom and more all reported workforce reductions as companies across industries grapple with economic pressures. Think inflation, supply chain challenges and more.

Medtech has shown some resilience in the present environment. Some major medical device companies released positive earnings.  However, others announced headcount reductions, citing macroeconomic headwinds. Others felt the weight of regulatory issues and restructuring efforts.

Here are a few companies across medtech that enacted layoffs over the past several months.


In 3M’s fourth-quarter earnings report, the company announced that it plans to reduce its global manufacturing workforc…

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