Robotics & Automation News

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EndoQuest Robotics applies for FDA approval for its new robotic surgery device

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EndoQuest Robotics, a privately held medical device company and pioneer in the development of flexible endoluminal robotic technologies, has submitted an Investigational Device Exemption (IDE) application for its pivotal colorectal clinical study.

EndoQuest says its mission is to “transform surgical outcomes for minimally invasive surgery” (MIS) with its groundbreaking flexible robotic system.

This IDE will enable EndoQuest to begin their Prospective Assessment of a Robotic-Assisted Device in Gastrointestinal Medicine (PARADIGM) study, which is a prospective, multi-center, open-label study. [Read more…] about EndoQuest Robotics applies for FDA approval for its new robotic surgery device

US FDA grants authorization for Distalmotion surgical robot

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Distalmotion has been granted De Novo approval by the US Food and Drug Administration (FDA) to market the Dexter Surgical Robot for adult inguinal hernia repair.

This significant milestone marks another step forward in Distalmotion’s mission to empower robotic surgery excellence by expanding access and improving care with robotic assisted surgery in the hospital outpatient and ambulatory surgery centers (ASC’s) where over 90 percent of inguinal hernia repairs are currently performed in the United States.

With more than 1,300 patients successfully treated in Europe, Distalmotion’s extensive experience has paved the way for bringing this innovation to the US market. [Read more…] about US FDA grants authorization for Distalmotion surgical robot

MMI completes first Symani microsurgeries in the US following FDA authorization

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Medical Microinstruments, a robotic surgery company, has completed its first clinical cases in the United States using the Symani Surgical System.

Both robotic-assisted microsurgical procedures were performed at the Department of Orthopaedic Surgery at Penn Presbyterian Medical Center.

The historic first US procedures were reconstructive extremity microsurgeries. In one case, the team performed a “free bone transfer” procedure on a patient who suffered a traumatic injury; the procedure involved transferring a segment of bone and skin from their leg to a damaged bone in their forearm. [Read more…] about MMI completes first Symani microsurgeries in the US following FDA authorization

Levita Magnetics wins FDA clearance for its robotic surgery system

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Levita Magnetics, whose mission is to help more patients get access to better surgery, says it has received US Food and Drug Administration (FDA) clearance for its MARS platform.

The Levita MARS system is a first-of-its-kind minimally invasive surgical platform aimed at the high-volume abdominal surgery market.

Harnessing the power of both magnets and machines, MARS reduces the number of incisions and enables surgeons to have complete control during laparoscopic procedures, all in a compact footprint designed to fit into existing operating rooms. [Read more…] about Levita Magnetics wins FDA clearance for its robotic surgery system

Think Surgical’s miniature robotic system developed with Sagentia gains FDA clearance

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Think Surgical’s Tmini Miniature Robotic System has received 510(k) clearance from the US Food and Drug Administration (FDA).

Think Surgical chose R&D consultancy Sagentia Innovation, a market-leading advanced surgical robotics developer, to support key aspects of the Tmini system’s development.

The Tmini system includes a wireless robotic handpiece that assists surgeons in performing total knee replacement. Following a CT based three-dimensional surgical plan, the Tmini robotic handpiece automatically compensates for surgeon hand movement to locate bone pins along precisely defined planes. [Read more…] about Think Surgical’s miniature robotic system developed with Sagentia gains FDA clearance

Think Surgical’s miniature surgical robotic system developed with Sagentia gains FDA clearance

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Think Surgical says its TMINI Miniature Robotic System has received 510(k) clearance from the US Food and Drug Administration (FDA).

Think Surgical chose R&D consultancy Sagentia Innovation, a market-leading advanced surgical robotics developer, to support key aspects of the TMINI system’s development.

The TMINI system includes a wireless robotic handpiece that assists surgeons in performing total knee replacement. Following a CT based three-dimensional surgical plan, the TMINI robotic handpiece automatically compensates for surgeon hand movement to locate bone pins along precisely defined planes. [Read more…] about Think Surgical’s miniature surgical robotic system developed with Sagentia gains FDA clearance

Distalmotion raises $150 million for its robotic surgery system

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Distalmotion has raised $150 million in new financing.

The company says this “significant fundraise reinforces the confidence” of its existing investors led by Revival Healthcare Capital.

Dexter, Distalmotion’s robotic platform, is in day-to-day clinical use in Europe, successfully treating patients across a multitude of complex and high-volume procedures in general surgery, gynecology, urology. [Read more…] about Distalmotion raises $150 million for its robotic surgery system

Noah Medical receives FDA clearance for its robotic surgery system

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Medical robotics innovator Noah Medical has received FDA clearance for its Galaxy System. The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

The majority of potentially cancerous lesions are located in the outer third of the lung, which is more difficult for doctors to reach for biopsy. Current technologies are limited in their ability to both reach and then precisely target these suspect lesions.

The Galaxy System’s advanced imaging technologies provide real-time location updates, and are designed to improve tool-in-lesion and diagnostic yield. [Read more…] about Noah Medical receives FDA clearance for its robotic surgery system

Galen Robotics closes oversubscribed $15 Million Series A funding round

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Galen Robotics, which describes itself as a “digital-surgery-as-a-service pioneer”, has completed the first close for an oversubscribed Series A round with $15 million in funding, including investment from Ambix Healthcare Partners, from Menlo Park, California.

Galen Robotics has submitted a new collaborative soft tissue surgical robot, intended to address unmet needs in the market, to FDA for consideration.

Galen plans to level the surgical playing field by erasing large capital expenditures associated with today’s surgical robots. Galen Robotics will be the first surgical robotics company to launch as “as-a-service” using the per-usage disposable model. [Read more…] about Galen Robotics closes oversubscribed $15 Million Series A funding round

Think Surgical receives FDA clearance for new robot

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Think Surgical has received clearance from the US Food and Drug Administration for its second-generation “active robot”.

Think Surgical is an innovator in the field of orthopedic active robot surgery, and says the FDA has cleared the its robotic system called TSolution One Total Knee Application.

The system features an active robot for total knee replacement, providing fully automated bone preparation, and gives surgeons a choice of implant options. [Read more…] about Think Surgical receives FDA clearance for new robot