HistoSonics receives CE mark for Edison histotripsy system for liver tumors

Regulatory Approvals
HistoSonics has received CE mark approval for its Edison histotripsy system, enabling the commercial launch of its non-invasive ultrasound platform for the treatment of liver tumors across Europe. The image-guided system uses focused ultrasound to...

HistoSonics receives CE mark for Edison histotripsy system for liver tumors

Regulatory Approvals
HistoSonics has received CE mark approval for its Edison histotripsy system, enabling the commercial launch of its non-invasive ultrasound platform for the treatment of...

Claria Medical earns FDA nod for integrated hysterectomy tissue extraction system

Regulatory Approvals
Claria Medical has received FDA De Novo authorization for its Claria System, an integrated tissue containment and removal device designed for minimally invasive hysterectomy...

Zeta Surgical receives FDA clearance for robotic TMS stereotactic system

Regulatory Approvals
Zeta Surgical has received FDA 510(k) clearance for its TMS Robotic System as a stereotactic instrument, expanding its portfolio of robotic technologies for transcranial...

Spiro Robotics earns FDA clearance for image-guided system for tracheal intubation

Regulatory Approvals
Spiro Robotics has received FDA 510(k) clearance for Spiro-VISTA, its handheld, dual image-guided robotic system designed to assist with tracheal intubation in adult hospital...

Get Weekly Newsletter

[hubspot type=form portal=25601863 id=e07d0241-001f-4840-8c08-6e5a4f7af710]

Finance

Funding

Clinical Trials

Nyra Medical enrolls first patient in mitral valve repair early feasibility study

Nyra Medical has enrolled the first patient in its ENHANCE early feasibility study evaluating the investigational CARLEN transcatheter cardiac leaflet enhancer for patients with...

AtaCor enrolls first patient in EV-ICD pivotal study with Abbott

AtaCor Medical has enrolled the first patient in the ALARION-EV pivotal trial evaluating its next-generation extravascular implantable cardioverter-defibrillator (EV-ICD) system, developed in partnership with...

First patient enrolled in study of Reflow Medical’s Spur system

Reflow Medical has enrolled the first patient in the DEEPER CHALLENGE study evaluating its Spur Peripheral Retrievable Scaffold System for below-the-knee treatment in patients...

Francis Medical announces publication of VAPOR 2 pivotal trial results

Francis Medical has published the initial report of its VAPOR 2 pivotal clinical study in The Journal of Urology, showcasing highly positive results for...

Innovation

Regulatory Approvals

HistoSonics receives CE mark for Edison histotripsy system for liver tumors

HistoSonics has received CE mark approval for its Edison histotripsy system, enabling the commercial launch of its non-invasive ultrasound platform for the treatment of...

Claria Medical earns FDA nod for integrated hysterectomy tissue extraction system

Claria Medical has received FDA De Novo authorization for its Claria System, an integrated tissue containment and removal device designed for minimally invasive hysterectomy...

Zeta Surgical receives FDA clearance for robotic TMS stereotactic system

Zeta Surgical has received FDA 510(k) clearance for its TMS Robotic System as a stereotactic instrument, expanding its portfolio of robotic technologies for transcranial...

Spiro Robotics earns FDA clearance for image-guided system for tracheal intubation

Spiro Robotics has received FDA 510(k) clearance for Spiro-VISTA, its handheld, dual image-guided robotic system designed to assist with tracheal intubation in adult hospital...

M&A

Archives

Latest articles

Load more

Popular categories

Funding1169Regulatory Approvals1045Innovation657Clinical Trials534Mergers & Acquisitions515GS Funding Tracker57