Formus Labs wins clearance for AI-powered ortho surgery planning

Formus Labs today announced FDA clearance of its Formus Hip automated radiological image processing software for hip replacement pre-op planning.

The New Zealand–founded company described the clearance as the last hurdle it needed to overcome to start making Formus Hip widely available in the United States.

According to Formus Labs, its software saves time for orthopedic surgeons so that they can consistently preoperatively plan for every case. Formus’ software combines AI and computational biomechanics to provides highly accurate outputs from scan to plan in under an hour.

“Today is a huge milestone in our journey to bring cutting-edge, pre-op surgery planning tools to surgeons, not only to make their work easier and more efficient, but also has the potential to improve the outcomes for their patients,” Dr. Ju Zhang, founder and CEO of Formus Labs, said in a news release.

“FDA clearance serves as significant validation of the accuracy and r…

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NeuroOne launches Evo sEEG electrodes in the U.S.

The Evo sEEG [Photo courtesy of NeuroOne]NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that it commercially launched its Evo sEEG electrode line in the U.S.

Zimmer Biomet holds exclusive worldwide distribution rights to the Evo Cortical and sEEG product lines. NeuroOne expects the line to utilize Zimmer Biomet’s Rosa One Brain robotic surgery platform for neurosurgical procedures. Zimmer paid $3.5 million to NeuroOne under the deal in August 2022. That came after an up-front payment of $2 million in 2020. NeuroOne began shipping commercial orders in the deal in November 2022.

“The commercial launch of the Evo sEEG platform represents one of the most impactful milestones in our company’s history,” said NeuroOne CEO Dave Rosa. “Paired with Zimmer Biomet’s ROSA One Brain robotic platform and broad distribution network, we believe the Company is well positioned in the market given the synergies that exist between our novel thin film ele…

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Zimmer Biomet’s profits were 16 times greater in Q1

Zimmer Biomet (NYSE: ZBH) + saw its stock rise today on Street-beating first-quarter results and raised guidance that analysts described as impressive. 

ZBH shares were up more than 3% to $143.68 by late morning. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up slightly.

News of the strong Q1 comes a day after Zimmer Biomet announced its latest acquisition — Ossis, a maker of personalized 3D-printed implants.

ZB’s results should add to the case that this could be a boom year for the orthopedic device market. The space is benefitting from a bounce-back of procedures as the COVID-19 situation normalizes.

BTIG analysts’ note had the headline, “Orthopedics is having its moment, and ZBH is benefiting.” Along with the backlog of patients, there are easy comps and multiple technologies that provide faster recovery, according to …

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Zimmer Biomet to acquire 3D-printed implant maker Ossis

Zimmer Biomet (NYSE: ZBH) +  announced today that it reached a definitive agreement to acquire Ossis, a maker of personalized 3D-printed implants.

Ossis also offers complex hip replacements, including second-time replacements and ones involving bone tumors and trauma.

The company boasts rapid design and production of personalized implants. This aligns with ZB’s commitment to providing personalized experiences, according to a news release.

“Combining Ossis’s more than 16 years of clinical experience and engineering expertise with Zimmer Biomet’s extensive network across Asia Pacific, Europe, the Middle East and Africa demonstrates our commitment to bring transformative med tech advancements to patients in need,” said Sang Yi, Zimmer Biomet Asia Pacific group president.

ZB entered into an agreement with Ossis in July 2021. The agreement made Ossis the company’s Asia Pacifi…

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The top orthopedic device news out of AAOS 2023

Stryker’s next-gen Mako total robotic knee surgery system and more AI integration for Zimmer Biomet’s ZBEdge surgical platform topped the news at this year’s AAOS 2023.

The American Academy of Orthopaedic Surgeons 2023 annual meeting drew top medical and medtech talent to Las Vegas from March 7–11.

Here is a roundup of major news coming out of the show:

Stryker launches Mako Total Knee 2.0 surgical robotics platform The goal of Stryker’s Mako robotic-arm assisted surgery is to provide more predictable outcomes. [Image courtesy of Stryker]Stryker unveiled Mako Total Knee 2.0 at AAOS 2023. Informed by more than 500,000 procedures, Stryker said it designed the next-gen version of the robotic knee surgery system to provide an elevated user experience with customizable workflows and other key features. New features include a digital tensioner for assessing knee stability intraoperatively during total knee arthroplasty — without the need f…
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Zimmer Biomet unveils enhancements to ZBEdge platform

The Canary Medical orthopedic analytics module integrates with the Persona IQ Smart Knee. [Image from Zimmer Biomet’s website]Zimmer Biomet (NYSE:ZBH) today announced plans to unveil new enhancements to its ZBEdge Dynamic Intelligence platform.

Warsaw, Indiana-based Zimmer Biomet designed the platform to integrate its digital, robotic and implant technologies. It connects and collects objective data throughout the entire episode of care. The company aims for ZBEdge Dynamic Intelligence to transform data into insights and elevate the standard of care.

Zimmer Biomet plans to unveil enhancements this week at the American Academy of Orthopaedic Surgeons (AAOS) 2023 Annual Meeting in Las Vegas.

Enhancements include updates for the MyMobility platform, Rosa Knee, Persona IQ and more.

“Nearly two years following its introduction, ZBEdge Dynamic Intelligence continues to deliver innovations with breakthrough technologies designed to enable smarte…

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Could 2023 be a boom year for orthopedic devices?

The goal of Stryker’s Mako robotic-arm assisted surgery is to provide more predictable outcomes. [Image courtesy of Stryker]The orthopedic devices market is expected to reach nearly $50 billion this year as procedures bounce back from COVID-19, according to GlobalData.

GlobalData predicts the orthopedic surgical robotics space will be even hotter this year, growing 25.6% year-over-year to $984 million.

“Boosted by artificial intelligence (AI) and machine learning, new generations of orthopedic robots are expected to further improve clinical outcomes. Unlike the general surgery robotics market — which is dominated by only one company, Intuitive Surgical — all major orthopedic manufacturers are competing in the orthopedic robotics market,” Tina Deng, principal medical devices analyst at GlobalData, said in a news release posted Feb. 1.

In addition, Global Data noted that the pandemic has accelerated the shift of procedures to outpatient or ambulat…

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New medtech to watch for in 2023: boosting health outcomes

[Image from Pixabay]As earnings season is upon us, we’re receiving a clearer view of what new medtech could be launching this year in the medical device space.

Companies still feel hamstrung by macroeconomic pressures, supply chain issues and more. However, many pointed out that 2023 has plenty to look forward to. Several quarterly reports and earnings calls included positive outlooks for the year ahead, with plenty of companies banking on significant revenue growth and other successes.

For many, that comes down to some new medtech product launches. Here are a few picked out from earnings calls and other announcements that you might want to look out for:

Abbott

On Abbott’s earnings call last month, CEO Robert Ford pointed to product launches as a major part of its outlook for 2023.

Abbott said it expects to log adjusted EPS of between $4.30 and $4.50. Excluding COVID-19-related sales, the company expects high-single-digit revenue growth.<…

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Zimmer Biomet beats The Street in Q4, expects continued ‘macro pressures’

Zimmer Biomet (NYSE:ZBH) shares ticked up as the market opened on fourth-quarter results that beat the consensus forecast.

Shares of ZBH rose 1.7% at $129.50 apiece in the early morning. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose 14.9%.

The Warsaw, Indiana-based orthopedic device maker posted losses of $130.5 million. That amounts to 62¢ per share on sales of $1.83 billion for the three months ended Dec. 31, 2022.

Zimmer Biomet’s losses continued to slide, dipping from $84 million this time last year. However, the company recorded sales growth of 2.7%.

Adjusted to exclude one-time items, earnings per share totaled $1.88. That comes in 5¢ ahead of expectations on Wall Street. Zimmer Biomet also beat The Street on sales, as analysts projected revenues of $1.76 billion.

Highlights in the quarter included the FDA clearance of the Persona OsseoTi keel tibia for …

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Zimmer Biomet to acquire soft tissue healing company Embody

Zimmer Biomet (NYSE:ZBH) today announced it entered a definitive agreement to acquire soft tissue healing developer Embody for up to $275 million.

Through the deal, Zimmer Biomet will pay $155 million at closing and up to an additional $120 million upon Embody achieving future regulatory and commercial milestones over a three-year period. The acquisition is expected to be accretive to overall revenue growth and slightly dilutive to adjusted earnings per share in 2023.

“Embody’s differentiated products and innovative pipeline in the area of sports medicine support our continued focus on and investment in high-growth markets and underscores our commitment to bringing meaningful new advances to patients and surgeons,” Zimmer Biomet President and CEO Bryan Hanson said in a news release. “The planned acquisition of Embody is an important step in the ongoing transformation of ZB and the execution of our strategic priority to increase long-term…

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DeviceTalkers assemble for the final Newsmakers of 2022

In this episode, your diligent team of DeviceTalkers assembled to review our Top 10 events, trends and newsmakers of 2022.

Executive Editor Chris Newmarker, Pharma Editor Brian Buntz, Managing Editor Jim Hammerand, Senior Editor Danielle Kirsh and Associate Editor Sean Whooley joined me, DeviceTalks Editorial Director Tom Salemi, for the latest DeviceTalks podcast.

We’ve got some highs — robots, diabetes — and some lows — supply chain, recalls — and a whole lot of interesting things in between. All-in-all, we’re bullish on what’s to come in 2023! And we only mentioned COVID-19 once.

Companies mentioned in our wide-ranging discussion include Abbott, Abiomed, Ambu, Becton Dickinson, Boston Scientific, CMR Surgical, Dexcom, embecta, Intuitive, Johnson & Johnson Medtech, Medtronic, Neuralink, Philips, Senseonics, Stryker, Synchron, Vicarious Surgical, Zimmer Biomet, ZimVie and many more.

You can listen to other DeviceTalks Podcast Network shows at…

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Canary Medical integrates analytic module with Zimmer Biomet smart knee implant

The Canary Medical orthopedic analytics module integrates with the Persona IQ Smart Knee. [Image from Zimmer Biomet’s website]Canary Medical announced today that it introduced its first orthopedic analytic module: Canary Quantiles recovery curves.

Recovery curves utilize movement data measured by Canary Medical’s proprietary implantable Canturio TE tibial extension sensor technology. The sensor technology enables Zimmer Biomet’s Persona IQ smart knee implant.

Persona IQ with the Canturio TE tibial extension sensor technology collects activity measures and gait parameters for at least 10 years. By pooling parameters across the Persona IQ patient population, recovery curves provide population data for activity levels and knee kinematics. It also ranks each patient’s knee performance against peers. The technology does so based on age, group, gender and time since surgery, according to a news release.

Canary Medical said clinicians may n…

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