MassDevice Archives - Page 3 of 587 - Medical Design Sourcing

How Solventum plans to create value after spinning out of 3M

Bryan Hanson, soon-to-be CEO of 3M’s Solventum healthcare spinoff, is no stranger to major changes in medtech.

He had direct involvement in medtech’s largest spinoff, when Covidien separated from Tyco. Hanson then led the integration of Covidien into Medtronic in medtech’s largest-ever acquisition. While at Medtronic, he also led the divestiture of its Patient Recovery business to Cardinal Health.

After several years in the corner office at orthopedic giant Zimmer Biomet, he’s now tasked with leading the planned Health Care spinoff at 3M.

“I have a lot of knowledge and experience in transformation,” Hanson said during Solventum’s inaugural Investor Day event. “[They were] all different transformations, but what you’ll find is some commonality in every transformation. There are always differences, but there’s always commonality as well. So I will bring experience to make sure that this transforma…

GE HealthCare, Nvidia team up to bring AI to ultrasound

GE HealthCare (Nasdaq: GEHC) + announced that it utilized Nvidia technology to develop an AI-powered research model called SonoSAMTrack.

SonoSAMTrack combines a promptable foundation model for segmenting objects on ultrasound images called SonoSAM. It segments anatomies, lesions and other essential areas in ultrasound images. GE HealthCare also offers a streamlined version called SonoSAMLite.

The latest development builds on a long-term AI collaboration between GE HealthCare and Nvidia. Nvidia, a leader in AI computing, has worked with a number of medtech companies to incorporate AI into their technologies. Johnson & Johnson MedTech announced this week that it plans to accelerate and scale AI for surgery in partnership with Nvidia.

Asensus Surgical linked up with Nvidia last year to deliver novel clinical intelligence to surgeons in surgical robotics. Medtronic also partnered with Nvidia to enable an AI Acce…

Avail Medsystems tech sold to robotics startup founded by former Auris leaders

The Avail Medsystems telepresence console beams video, audio and information to laptops and tablets. [Photo courtesy of Avail Medsystems]Medical robotics startup Mendaera has purchased the technology of Avail Medsystems and hired some of its employees, Mendaera co-founder and CEO Josh DeFonzo said in an exclusive interview.

The deal includes “substantially all” of Avail’s assets, said DeFonzo, who offered new details on his company’s objectives as it exits stealth mode.

He declined to disclose financial terms of the deal.

Avail shut down last year for lack of funding. DeFonzo said Mendaera will support customers that were using the existing Avail technology and consoles as its R&D group works on the product roadmap regarding console size and/or features in the coming quarters. However, Avail’s partnership with Medtronic is not part of the transaction, he said.

“We certainly would be happy to work with Medtronic…

Johnson & Johnson MedTech partners with Nvidia on AI in surgery

Johnson & Johnson MedTech announced today that it plans to accelerate and scale AI for surgery in partnership with Nvidia.

The two companies paired up to support increased access to real-time analysis and global AI algorithm availability. They hope to affect surgical decision-making, education and collaboration across the connected operating room (OR).

This marks the latest medtech collaboration involving Nvidia, a leader in AI computing. Asensus Surgical linked up with Nvidia last year to deliver novel clinical intelligence to surgeons in surgical robotics. Medtronic also partnered with Nvidia to enable an AI Access platform to boost the GI Genius intelligent endoscopy module’s capabilities.

Read more on Nvidia and its use of generative AI in the pharmaceutical industry here.

According to a news release, the companies executed a memorandum of understanding to accelerate AI for Johnson & Johnson MedTech’s extensive surgical technolog…

Intuitive details da Vinci 5 launch plans with limited supply of next-gen surgical robotics systems

Intuitive Surgical’s da Vinci 5 is the device developer’s fifth-generation surgical robotics system. [Image courtesy of Intuitive Surgical]Intuitive Surgical (NASDAQ: ISRG) + is planning a phased launch of its da Vinci 5 that will stretch into next year, executives said today.

Intuitive won FDA 510(k) clearance for its next-generation surgical robotics system last week, nearly one decade after winning clearance for the da Vinci Xi system.

“We are planning for a limited launch starting in the U.S. as we optimize manufacturing and supply chains, and progressively expand our manufacturing capacity,” CFO Jamie Samath said. “We expect to be in this limited launch phase into 2025. During this period, we will be focused on customers that collaborated with us during the development period and those customers who have mature robotic programs and have a need to expand capacity.”

Others who…

Carlsmed raises $52.5M Series C for spine surgery platform

Carlsmed announced today that it raised $52.5 million in a Series C funding round co-led by B Capital and U.S. Venture Partners.

The Carlsbad, California-based AI-enabled personalized surgery company plans to use the funds to accelerate commercialization efforts. It wants to boost the commercialization of its aprevo personalized spine surgery platform for lumbar fusion procedures, in particular.

The company also hopes to put the funds toward developing aprevo for cervical fusions. Carlsmed plans to launch that offering in 2025.

Carlsmed already holds FDA breakthrough device designation for the aprevo lumbar and cervical patient-specific interbody fusion devices. Its implantable devices and software platforms hold FDA clearance for lumbar spine fusion. That includes in anterior, lateral and transforaminal approaches.

Dr. Robert Mittendorff, general partner and head of healthcare at B Capital, said in a news release that Carlsmed is “transform…

FDA clears Ventris Medical Amplify standalone bone graft putty

Ventris Medical recently received FDA 510(k) clearance for its Amplify standalone bone graft putty in the intervertebral disc space.

The Newport Beach, California-based company designed Amplify to optimize cell proliferation and bone formation. It comprises the Amplify biphasic (HA-to-βTCP) ceramic granules suspended in an alkaline oxide polymer carrier. It can be used standalone or combined with autograft bone as a bone graft extender.

“We are very pleased to receive FDA clearance for Amplify Synthetic Bone Graft Putty for the intervertebral disc space. This technology combines 2 heavily studied biphasic mineral components, which are surface activated through our patented process and suspended in our proprietary polymer carrier,” CEO Russell Cook said in a news release. In a market crowded with a plethora of commodity offerings, our company mission is to develop next-generational devices that bring excitement to the surgeon community as well as our…

Siemens Healthineers to close Fast Track Diagnostics unit

Siemens Healthineers announced today that it intends to close its Fast Track Diagnostics Unit in a move that affects just shy of 100 workers.

The business closure affects about 90 employees, mostly based in Luxembourg. The company has conversations underway with local employee representatives and plans to follow local labor regulations and guidelines in accordance with standard company practice. It expects to complete the closure by September 2024.

Fast Track Diagnostics first became a part of the Siemens Healthineers portfolio through an acquisition completed in December 2017. The collection of polymerase chain reaction (PCR) testing products comprised part of the company’s overall Diagnostics business. Siemens Healthineers said in a news release that it primarily sells this portfolio in Europe.

Since the COVID-19 pandemic’s peak, the company observed a significant decline in demand for the portfolio’s offerings. Fast Track Diagnostics…

Surgeons perform first total knee arthroplasty with Polaris mixed-reality surgical guidance tech

The Stellar Knee mixed-reality surgical guidance system. [Image courtesy of Polaris]Polaris announced today that surgeons performed the first total knee arthroplasty (TKA) during its Stellar Knee mixed-reality system.

Stellar Knee uses mixed-reality for surgical navigation and guidance. It guides TKA procedures by displaying measured and computed data overlaid directly in a 3D environment. The system acts as a spatial computer, creating continuous data exchange between the surgeon and software. Polaris says this enhances surgical decision-making while simplifying operating room workflow.

Polaris won FDA 510(k) clearance for the Stellar Knee system in November 2023 for use in TKA procedures. The first commercial case took place at New York-Presbyterian/Columbia University Irving Medical Center in New York.

“Stellar Knee represents a paradigm shift in the OR, as we aim to offer surgeons robot-like precision and real-time guidance throughout TKA procedures,” s…

Biotronik wins FDA breakthrough nod for below-the-knee resorbable scaffold

The Freesolve scaffold. [Image courtesy of Biotronik]Biotronik announced today that it won FDA breakthrough device designation for its Freesolve below-the-knee resorbable magnesium scaffold.

The company designed the Freesolve BTK RMS for individuals with chronic limb-threatening ischemia (CLTI). It recently launched the scaffold in Europe after receiving CE mark for treating coronary artery lesions.

Lake Oswego, Oregon-based Biotronik based its system on the BIOmag magnesium alloy and Orsiro drug-eluting stent coating technology. The company says it delivers proven safety, improved deliverability and optimal performance, plus vessel support during and after implantation. Previous data demonstrated 99.6% degradation of magnesium 12 months after implantation into coronary arteries.

In BTK interventions, Biotronik says the Freesolve’s characteristics can offer particular value. In these situations, vessel scaffolding in the short-term resists vessel reco…

FDA clears automated insulin delivery system from Sequel Med Tech

The twiist automated insulin delivery system. [Image courtesy of Sequel]Sequel Med Tech announced today that its partner, DEKA R&D, won FDA 510(k) clearance for its automated insulin delivery (AID) system.

The twist system, powered by Tidepool, directly measures the volume and flow of insulin delivered with every microdose. It offers the capability and flexibility to address each patient’s individual dosing needs. Sequel will market the system, which is cleared for people ages six and up with type 1 diabetes.

Sequel CEO and co-founder Dr. Alan Lotvin said clearance marks “a pivotal first step” on the company’s mission. The company expects to distribute the system through the pharmacy channel as well. That should offer a convenient, affordable way to start on an AID system, Lotvin said.

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

Titan Medical enters merger with Conavi Medical

Titan Medical announced today that it entered into a definitive amalgamation agreement to combine with Conavi Medical.

The companies aim to combine in an all-stock transaction, focusing on commercializing Conavi’s Novasight Hybrid system. Conavi designed Novasight Hybrid to guide common minimally invasive coronary procedures.

This merger comes after more than a year of uncertainty around the future at Titan Medical. In late 2022, Titan suspended a special meeting of shareholders meant to vote on a share consolidation plan. Management decided to begin a strategic review, with a sale of the company considered a possibility. Titan also announced cost-cutting measures that included the furloughing of 40 employees.

In a news release, the company said it conducted outreach to more than 40 potential counterparties and halted the development of its ENOS surgical robot in February 2023. To avoid insolvency, the company began selling assets and licensed its …