Major CE marked Robotics, General Surgery, Ultrasound Medical Technology: Retrospective Analysis of the sector from March 2023 until March 2024
Robotics and General Surgery sector has been rapidly growing for the last 10 years and we have witnessed an adoption of the technology throughout the globe.
From Laparoscopic surgery to the dental procedures currently there are multiple applications available.
2023 was a difficult year for MedTech industry funding overall. That being said I have decided to look retrospectively back to understand who still managed to ger CE marks from March 2023 until March 2024.
As it turns our Robotics and General Surgery market raised more than 1b USD in funding.
What happened in terms of CE marks between 2023 and now?
Robotics Surgery
Intuitive receives CE mark for da Vinci Single-Port surgical system 26 Jan 2024
Intuitive, a minimally invasive care and the pioneer of robotic-assisted surgery specialist, has received CE mark approval for the da Vinci Single-Port (SP) surgical system for endoscopic abdominopelvic, thoracoscopic, transoral otolaryngology, transanal colorectal, and breast surgical procedures.
Brain Navi’s neurosurgical robot used in 100th surgical procedure in January 2024 and plans for CE mark later this year!
Taiwan-based surgical robot firm Brain Navi has revealed that the 100th procedure has been performed using its neurosurgical navigation robot, NaoTrac. The milestone was reached during a surgery conducted by Dr. Hao-Yu Chuang, the director of the neurosurgery department at Annan hospital in Tainan, Taiwan.
NaoTrac utilises Surface Mapping Auto-Registration Technology (SMART), which combines robotics, artificial intelligence (AI) and machine vision to streamline surgical procedures with real-time images and less invasive outcomes.
Epione Robotic Platform Nabs CE Mark for Lung Tumors in September 2023
Quantum Surgical, a French medical robotics company, recently announced it has obtained expanded CE mark approval for its Epione robotic platform in the treatment of lung tumors. Epione is a robotic-assisted percutaneous ablation system that uses a robotic arm, a navigation system, and camera as an alternative to surgery in which a needle is inserted through the skin to the tumor to destroy it.
This, according to the company, makes it possible to treat particularly difficult to reach tumors, whether that be due to their size or location.
Moon Surgical wins CE mark for Maestro surgical robot in April 2023
Moon Surgical announced today that its Maestro system for surgical robotics received CE mark approval in Europe.
To date, the French-American surgical robot maker said 50 patients in Europe underwent Maestro-assisted surgery. These took place in a clinical trial led by Dr. Guy-Bernard Cadière in Brussels, Belgium.
Ultrasound Devices
Clarius wins CE mark for wireless handheld ultrasound January 17, 2024
Clarius has launched the CE-marked PAL HD3 ultrasound scanner in the European Union and the UK.Canadian Clarius Mobile Health has received a CE mark for its wireless handheld whole-body ultrasound scanner, Clarius PAL HD3.Concurrently the company has also launched the device in the European Union and the UK, as per a 17 January press release.
The Claruis’ handheld device can provide high-resolution images up to 40 cm in depth from the skin surface.The PAL HD3 device uses an eight-beamformer processing technology, a radio frequency (RF) technique that allows wireless signals to be targeted toward a specific endpoint. The beamforming technology is also used by the higher-end traditional counterparts.
Insightec’s Exablate Neuro secures second CE mark for essential tremor treatment in September 2023
Insightec’s magnetic resonance-guided focused ultrasound (MRgFUS) Exablate Neuro platform has received an additional CE mark to market its essential tremor treatment in the European Economic Area, Turkey, and the UK.
General Surgery
ProCell secures CE-marked approval for blood recovery unit in February 2024
ProCell Surgical has received CE-marked approval for its Sponge Blood Recovery Unit, allowing it to enter the European Union market.
The certification indicates that ProCell’s product complies with the EU’s Medical Devices Regulation (EU) 2017/745.The company’s patented technology modernises the process of surgical sponge-blood recovery, enhancing intraoperative autotransfusion (IAT) systems in hospitals.
Ethicon receives CE mark for haemostatic sealing patch November 16, 2023
Johnson & Johnson MedTech company Ethicon has obtained CE mark approval for its adjunctive haemostatic sealing patch, ETHIZIA.
It was approved as an adjunctive haemostat for disruptive bleeding on internal organs, except neurological and cardiovascular.
Featuring synthetic polymer technology, ETHIZIA is claimed to be the first and only haemostatic matrix that is equally productive and active on both sides.
Palliare Announces EU CE Mark Approval Under New Medical Devices Regulation in July 2023
Palliare, a leading developer of advanced insufflation technologies, has received EU CE Mark certification under the new EU Medical Devices Regulation (MDR) for its EVA15 insufflator and smoke evacuation system.
This makes it one of the first laparoscopic and endoscopic insufflators to meet the new more extensive regulatory requirements introduced in 2021 for medical devices in Europe and will now permit the company to commence shipments to the European market with immediate effect.
Creo Medical’s Speedboat Inject device gets CE mark for upper GI use in June 2023
UK-based Creo Medical has secured CE mark approval for its Speedboat Inject device for upper gastrointestinal (GI) use in Europe.
Earlier, the device received a CE mark for lower GI tract for use only within European markets but this new clearance allows the use of the device for endoscopic procedures through the complete GI tract, from the mouth down to the stomach, besides within the lower GI tract.
Aesthetic Surgery
Establishment Labs wins CE mark for aesthetic surgery tools in May 2023
Medical technology company Establishment Labs has received a CE mark for its minimally invasive surgical tools designed for use in aesthetic surgery procedures.
The approved surgical tools include the Motiva inflatable balloon, Motiva channel dissector, as well as Motiva injector.
These devices were approved under the European Medical Device Regulation (MDR).
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