Vicarious Surgical details its regulatory plans with FDA

[Image courtesy of Vicarious Surgical]Vicarious Surgical (NYSE:RBOT) announced in its quarterly earnings report that it set its FDA regulatory process in motion with a pre-submission.

CEO Adam Sachs said in a news release that the robotic surgery technology developer, which just completed its first quarter as a publicly-traded company, filed a “detailed regulatory plan” in the form of a pre-submission to the FDA as it looks to move toward 510(k) approval for its robotic surgical platform.

“This quarter marks our entry into the public markets, and I am incredibly proud of our teams and employees for their contributions to our company’s growth to date,” Sachs said in the release. “We are well-positioned to continue development of our next generation robotics system and are also pleased to announce that we have just filed a detailed regulatory plan in the form of a pre-submission to the FDA. We remain committed to transforming outcomes for sur…

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Vicarious Surgical stock continues to rise

[Image courtesy of Vicarious Surgical]It’s so far, so good for Vicarious Surgical (NYSE:RBOT) during its first week of trading as a public company.

The robotic surgery company’s shares were up more than 19% to $15.05 by midday today. During the company’s first day of trading yesterday, shares rose 2% to $12.60 apiece, even as the Dow Jones Industrial Average fell about 600 points.

In April, the surgical robotics company announced that it would go public through a $1.1 billion merger with the special purpose acquisition corporation D8 Holdings — a deal that the SPAC’s shareholders approved on Sept. 15. The roughly $220 million in proceeds from the SPAC merger is expected to fund the further development and planned commercialization of the single-incision Vicarious system, which received FDA breakthrough device designation in 2019.

Vicarious’ robot includes features such as arms that replicate human motion, and it boasts 9 degrees of f…

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DTW Weekly Podcast – Digging Deeper into Cleerly Health $43 million round

In this week’s DeviceTalks Weekly Podcast, we talk with Dr. James Min, the founder and CEO of Cleerly Health, a potentially disruptive diagnostics company that raised $43 million last week. Dr. Min explains how Cleerly Health formed from his work at Weill Cornell Medicine. But, more importantly for entrepreneurs and executives, he walks listeners through the steps he took to prepare for the fund-raising. In our next episode we’ll talk with two VCs who invested in the company to hear why Cleerly’s pitch worked.

We also talk with Jeremy Maniak, the CEO of Minnetronix, which is celebrating its 25th year in business. Maniak shares why medtech is such a draw for quality engineers who want to work for a purpose and work with the top technology. He also takes us through the process that led to Minnetronix creating its own medical device. Maniak, an electrical engineer himself, says Minnetronix will partner with OEMs to sell the device.

Chris Newmarke…

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MedTech 100 roundup: Nearing new highs once again

Having hit a downturn as the summer neared, the medtech industry is now consistently on the rise as June comes to a close.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the week (June 25) at 113.42 points, producing a 2.5% rise from the 110.64-point mark set one week prior (June 18). In all, the industry has risen 5.9% over the past three weeks.

The recent upswing shows no signs of slowing after the industry’s progress came to a halt with a -1.4% dip earlier this month. The index looks set to close in on the 114.58-point mark set in April, marking the industry’s all-time best performance.

Even with some recent setbacks, 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 22.9% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus a 82.6% increase from the mid-pandemic low …

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Vicarious Surgical opens new corporate HQ in Massachusetts

[Image courtesy of Vicarious Surgical]Vicarious Surgical announced today that it established a new corporate headquarters in Waltham, Mass.

The company, which seeks to bring robotics and virtual reality to minimally invasive surgery, said in a news release that the new headquarters will expand its core business functions and house approximately 250 employees.

With what the company describes as a “rapidly growing team,” Vicarious leased a 42,000 square-foot facility at 78 Fourth Avenue in Waltham. The facility will house a full-scale operating room for robotics testing, along with research and development capabilities and company operations.

Vicarious Surgical said it is also expanding its manufacturing capabilities with the development of a comprehensive manufacturing facility, including a clean room, within the new headquarters.

In April, the surgical robotics company announced that it would go public through a $1.1 billion merger with D…

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MedTech 100 roundup: Industry skies to all-time high

The medtech industry hit a slight lull in the early stages of 2021 and, after signs of a rebound, it has soared beyond levels ever before seen.

MassDevice‘s MedTech 100 Index had been building up steam in the month of April, rising from 102.16 points at the beginning of March all the way to 109.39 to end the week before last (April 9). Having only set its previous all-time best of 110.96 on Feb. 15, the industry’s topsy-turvy run gave no indication of which direction it was heading next.

However, after the rise over the past couple of weeks, the industry rode that wave to a new all-time high of 112.25 to end last week on April 16. That represents a 2.6% rise from the previous week’s tally.

Improvements continue to shine a light on the strong position the industry has settled into a year on from the height of the COVID-19 pandemic’s impact on medtech, as the industry has produced an 21.6% rise from the pre-pandemic high of 92.32 (set on Feb. 1…

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DTW Podcast: How is Zimmer Biomet waging the ortho data war? Do medical devices carry physics-based biases?

This week’s DeviceTalks Weekly Podcast guests

In this week’s DeviceTalks Weekly Podcast,  Liane Teplitsky, vice president and general manager of worldwide robotics at Zimmer Biomet, shares her excitement for the burgeoning data business emerging in orthopedics.

Teplitsky, an engineer who built her medtech career in cardiac R&D and sales at St. Jude and Abbott, walks us through the interconnected offerings of Zimmer’s ZB edge suite of digital and robotics technologies.

In a separate interview, we talk with Achuta Kadambi, assistant professor at the UCLA Samueli School of Engineering, about a column he contributed to Science suggesting physics may be causing medical devices to perform at varying levels in people of different races.

Kadambi explains his own work in the field and suggests how medical device developers may want to move forward in the future.

See our initial report in Medical Design and Outsourcing here.

Chris New…

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Vicarious Surgical to go public in $1.1B SPAC deal

[Image courtesy of Vicarious Surgical]Vicarious Surgical will go public through a $1.1 billion special purpose acquisition company (SPAC) deal, the robotic surgery pioneer announced today.

Vicarious, which has sought to bring robotics and virtual reality to minimally invasive surgery, will trade on the New York Stock Exchange under the symbol RBOT after the merger with D8 Holdings.

Hong Kong–based D8 Holdings’ acquisition of Vicarious Surgical will add more than $425 million in cash to Vicarious’s balance sheet upon the deal’s close, including a $115 million private investment in public equity (PIPE) priced at $10 per share. Pipe investors include strategic investor BD, new institutional investors and existing investors including Bill Gates, Vinod Khosla’s Khosla Ventures, Eric Schmidt’s Innovation Endeavors, and Philip Liang’s E15 VC.

The SPAC deal comes nearly a year and a half after FDA provided breakthrough device des…

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DTW Podcast: Vizient on PPE, Vicarious on VR-aided robotics and let’s all hope for pumpernickel

This week’s episode of DeviceTalks Weekly is brought to you by the later V, as in Vizient and Vicarious Surgical.

Bharat Sundaram, COO and president of Vizient, will share how the healthcare supplier is strengthening the supply of PPE for hospitals. He’ll also reveal when the company expects to see US hospitals running at pre-COVID levels. Hint: It’ll be a while.

Adam Sachs, CEO of Vicarious Surgical, tells us how the company will put a new round of capital from high-powered investors including Bill Gates and Vinod Khosla to work in developing to develop a surgical system employing robotic and virtual reality technologies. How does the start-up expect to compete with the established leaders in the robotics space?

Co-host Chris Newmarker, executive editor, life sciences, will walk us through the five biggest newsmakers on the MassDevice site involving C.R. Bard, Theranos, and Medtronic. Number one may surprise you, but given the time, perhaps …

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Vicarious Surgical raises $13.2M toward commercializing surgical robotics, VR

Vicarious Surgical raises new round of funding

Vicarious Surgical Inc. last week announced that it has raised $13.2 million in funding. The Cambridge, Mass.-based company said the latest investment will help it develop and commercialize its product, which applies robotics and virtual reality to minimally invasive surgery.

In 2014, Adam Sachs and Sammy Khalifa co-founded Vicarious Surgical along with Dr. Barry Greene, a board-certified bariatric and general surgeon. The company has patented its virtual reality robot-assisted surgical system.

Get the full story at our sister site, The Robot Report.

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