MassDevice Archives - Page 6 of 587 - Medical Design Sourcing

Philips, AWS expand partnership on digital pathology in the cloud

Philips (NYSE: PHG) + today announced an expanded partnership with Amazon Web Services (AWS) based around digital pathology in the cloud.

The two initially linked up about a year ago, inking a deal to develop generative AI applications. This partnership centered around Philips’ imaging archiving and communications system. It wasn’t the first time a medtech giant linked up with AWS, as GE HealthCare and Baxter also announced similar deals in the past.

Today’s announcement aims to unite Philips’ expertise in the digitization of pathology with AWS’ leadership in scalable, secure cloud solutions.

Together, Philips and AWS hope to advance digital pathology. They want to help labs efficiently store, manage and analyze growing volumes of digital pathology data. This would, in turn, enable the adoption of digital workflows to increase productivity.

Additionally, Philips says patholog…

SS Innovations uses surgical robot in mitral valve replacement

SS Innovations announced today that surgeons successfully performed a mitral valve replacement using its surgical robot.

The procedure marks the world’s first mitral valve replacement using the company’s Mantra surgical robot. It took place at the Narayana Hrudayalaya Institute of Cardiac Sciences in Bengaluru, India. Dr. Nitin Kumar Rajput performed the surgery, guided by Dr. Sudhir Srivastava, SS Innovations’ founder and chair.

Mantra, the first surgical robot made in India, according to a news release, offers a cost-effective option for a range of surgical applications. It already has regulatory approval in India, Indonesia and Guatemala. SS Innovations already initiated the regulatory process in the U.S. and Europe as well. It hopes for approvals in the latter half of 2024 or 2025.

The system provides capabilities for multi-specialty uses. Its uses span cardiothoracic, head and neck, gynecology, urology, general surgery and more. Th…

Recall of Abbott HeartMate comms system is Class I

The HeartMate 3 LVAD. [Image courtesy of Abbott]The FDA deemed a recall of the Abbott (NYSE: ABT) + HeartMate Touch Communication System Class I, the most serious kind of recall.

Abbott warned of the potential for its HeartMate Touch System to unexpectedly stop or start. This recall is a correction, not a product removal, according to the FDA. The company reported eight injuries and zero deaths related to this recall.

In total, the recall affects 1,560 devices in the U.S. distributed between May 7, 2020, and Dec. 18, 2023. Abbott initiated the recall on Jan. 3, 2024.

The HeartMate Touch Communication system monitors patients who have an implantable HeartMate 3 left ventricular assist device (LVAD). Abbott has previously reported that HeartMate 3 can extend the lives of advanced heart failure patients by at least five years.

HeartMate’s communications system works with a controller and includes a tablet…

Roman to move out of CEO post at 3M, successor named

3M CEO Mike Roman [Photo courtesy of 3M]3M (NYSE: MMM) + announced today that it selected William M. Brown to succeed Mike Roman as CEO.

Brown’s appointment to the corner office goes into effect on May 1, 2024. Roman will shift to the role of executive chair of 3M’s board of directors with the same effective date.

“Bill’s strong track record as a CEO for a global technology company makes him the right leader for 3M,” Roman said in a news release. “He brings a wealth of experience in strategic leadership, innovation, and operational excellence to 3M. I look forward to working with him to build on our momentum in my new role as executive chairman.”

News of the shift at the top of 3M comes at an interesting time, as the manufacturing giant prepares to spin off its Solventum healthcare business.

Brown, 61, previously served as chair and CEO at L3Harris Technologies, an a…

Fast Five: iRhythm closes offering worth more than $660M; FDA accepts Onward BCI into advisory program

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, March 12, 2024.

Fast Five by MassDevice · iRhythm closes offering worth more than $660M; FDA accepts Onward BCI into advisory program

Boston Scientific reported positive results for the agent drug-coated balloon study. Fast Five hosts Danielle Kirsh and Sean Whooley talk about the technology and the data points that stick out.

Medtronic is highlighting the global performance of its MiniMed 780G automated insulin delivery system. Hear about what the new data highlights and some of the most compelling data the company highlighted.

The FDA has cleared Pulse Biosciences’ pulsed field ablation electrode technology. Whooley talks about what the PFA electrode technology does and some of the optimism that executives have.

Onward was accepted into an FDA advisor…

Affluent Medical touts first implant of artificial urinary sphincter

A screengrab from a video demonstration of the Artus device. [Image from Affluent Medical]Affluent Medical today announced the successful first-in-human implant of its minimally invasive urinary incontinence treatment device.

Dr. Roman Zachoval completed the first implant of Artus, an artificial urinary sphincter. Zachoval, head of urology at Thomayer University Hospital in Prague, implanted Artus in a 68-year-old male patient with severe urinary incontinence.

The procedure lasted about 80 minutes and went according to plan, according to a news release. Affluent Medical plans to activate the device six weeks after implantation, after the surgical wound healing process.

“Artus is easy to prepare and implant due to its innovative design compared to the previous generation of urinary sphincters. With the positioning of the cuff around the urethra and the implantation of the control unit the different steps of the implantation were straightforward,” Zacho…

Abbott reports data that backs TAVR, LAA systems

The Amplatzer Amulet LAAO device. [Image courtesy of Abbott]Abbott (NYSE: ABT) + today reported positive study data supporting its first-generation transcatheter aortic valve system and its Amplatzer Amulet.

Abbott reported its outcomes at the Cardiovascular Research Technologies (CRT) 2024 meeting.

The company first reported a pooled analysis from three clinical studies evaluating its Portico TAVR system, the predecessor to Navitor. It showed the safety and effectiveness of Portico for severe, symptomatic aortic stenosis in patients at high and extreme surgical risk through five years.

Abbott reported excellent sustained blood flow and prevention of paravalvular leaks (PVLs) with Portico. It also reported favorable clinical event rates at a high rate of accurate valve matching due to the wide range of annulus size.

The company also had data on the Navitor system, which maintained safety and effectiveness th…

Medtronic has positive Evolut TAVR data

The CoreValve Evolut TAVR implant. [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + today reported two different datasets that support its Evolut transcatheter aortic valve replacement (TAVR) system.

A cost-effectiveness analysis demonstrated the positive economic value of TAVR using Evolut in low-risk patients. It compared Evolut to surgical aortic valve replacement (SAVR). Then, Medtronic had contemporary data from its Evolut low-risk trial reinforcing long-term TAVR outcomes compared to SAVR.

Medtronic presented data at the Cardiovascular Research Technologies (CRT) 2024 Conference. The data follows Medtronic’s TCT presentation highlighting the success of TAVR when pitted against SAVR last October.

“At Medtronic, we continue to emphasize that valve design matters. These data further exemplify Medtronic’s dedication to providing differentiated treatment options like the Evolut …

3M board approves Solventum healthcare spinoff

3M (NYSE: MMM) + announced last week that its board of directors approved the planned spinoff of Solventum, its Health Care business.

Board approval further solidifies the company’s previously announced intent to spin Solventum into a standalone company on April 1. The St. Paul, Minnesota–based manufacturing giant first announced plans to spin off its Health Care unit in June 2022. It named the standalone company, which generates more than $8 billion in annual revenue, “Solventum” in November 2023.

Following board approval, 3M applied to list Solventum on the New York Stock Exchange under the “SOLV” ticker.

Solventum will include more than 20,000 employees, led by former Zimmer Biomet CEO Bryan Hanson as its CEO. The company also landed former Insulet CFO Wayde McMillan as he takes over the same post. Carrie Cox will serve as board chair and former NuVasive CEO Christopher Barry is the new Pre…

ClearPoint Neuro reports positive laser therapy results

The ClearPoint Prism neuro laser therapy system. [Image courtesy of ClearPoint Neuro]ClearPoint Neuro (Nasdaq:CLPT) today announced preclinical results highlighting the accuracy of its Prism neuro laser therapy system.

The Prism system features the only non-cooled laser applicator on the market, the company said. Its next-generation laser applicator technology eliminates the need for external cooling. This simplifies setup, reduces power and ablation time and lessens imaging artifact for more efficient workflows.

ClearPoint Neuro currently has the Prism laser in a limited market release at select academic medical centers in the U.S. The company also recently used Prism with its recently FDA-cleared Array software version 1.2 to improve the practicality of neurolaser therapy.

Investigators published their latest results from evaluations of Prism in the Journal of Neurosurgery. Data demonstrated accurate, near-real-time brain tissue temperature readings with …

Integra LifeSciences launches MicroMatrix Flex

Integra LifeSciences today announced it launched its MicroMatrix Flex dual-syringe system for urinary bladder matrix (UBM) access.

The Princeton, N.J.-based company designed MicroMatrix Flex to enable the convenient mixing and precise delivery of MicroMatrix paste to provide more convenient access to hard-to-reach spaces in wound management.

“MicroMatrix Flex has allowed me to expand how I use UBM technology in complex wound reconstruction procedures,” said Dr. Aaron Moore, an acute care surgeon at Mercy Health St. Vincent Medical Center. “In addition to the benefits of UBM technology, the flexible delivery tip addresses the need to access hard-to-reach geometries in complex wounds.”

MicroMatrix Flex is intended to manage wounds, including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds, trauma wounds and draining wounds.

The device has a flexi…

Boston Scientific has positive Agent DCB study results

The Agent drug-coated balloon. [Image from Boston Scientific]Boston Scientific (NYSE: BSX) + reported positive investigational device exemption (IDE) trial data for its Agent drug-coated balloon (DCB).

The DCB just this month won FDA approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented vessel. Agent serves as an alternative to traditional therapies like balloon angioplasty, additional layers of stenting or radiation. The paclitaxel-coated balloon transfers a therapeutic dose of drug to the vessel wall, helping to prevent ISR reoccurrence.

The FDA approved the device, which received breakthrough designation in 2021, thanks to results from the FDA IDE trial. Data presented at TCT 2023 demonstrated statistical superiority for Agent compared to uncoated balloon angioplasty. Boston Scientific set a primary endpoin…