Regulatory Approval Archives

Bruno Vision Care receives FDA approval for Deseyne Contact Lens with FusionTechnology

April 15, 2025

FDA grants 510(k) clearance to Turbett Surgical’s Instrument Pods

April 15, 2025

FDA clears first stapler for single-port robotics from Intuitive

April 15, 2025

Innoblative wins FDA IDE for electrosurgical device for breast cancer treatment

April 14, 2025

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FDA clears NeurAxis’ self-inflating balloon device RED

January 30, 2025

Guided Solutions Appoints Marco Müller as New Managing Director Germany to Drive Strategic Growth

November 6, 2024

Guided Solutions Appoints Manu Chhokra as Managing Director for Switzerland

October 16, 2024

FDA clears portable blood, IV fluid warmer from Mequ

June 10, 2024

Newsletter

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SecondWave secures $7m in funding for ultrasound device

Neuranics secures $8m for TMR magnetic sensing technology growth

Puzzle Medical Devices raises $30 million for heart pump

OSSTEC landed £2.5m to develop 3D-printed partial knee implants

Fire1 heart failure system performs well in first-in-human study

Data backs Cala neurostim for treating essential tremor

Anaconda Biomed enrolls first patient in study of funnel catheter for treating stroke

Study backs Median Technologies’ AI lung cancer screening software

Elixir Medical launches the LithiX hertz contact IVL system in Europe

Surmodics launches Pounce XL thrombectomy system

Voom Medical Devices to launch single-use sterile Revcon Screw System

Okami Medical launches SENDERO MAX Delivery Catheter

Bruno Vision Care receives FDA approval for Deseyne Contact Lens with FusionTechnology

FDA grants 510(k) clearance to Turbett Surgical’s Instrument Pods

FDA clears first stapler for single-port robotics from Intuitive

Innoblative wins FDA IDE for electrosurgical device for breast cancer treatment

Kandu Health and Neurolutions merge into BCI company targeting stroke care

Alcon agrees to acquire Lensar and its robotic cataract laser system

TOOsonix and Consultronix to introduce ultrasound skin therapy in Poland

Labcorp Announces Acquisition of Select Assets of BioReference Health’s Innovative Oncology and Related Clinical Testing Services Businesses

Tag: Regulatory Approval

Q’Apel Medical Secures U.S. Patent for its SelectFlex™ Technology

joimax® Receives FDA Clearance to Market EndoLIF® Delta-Cage and DoubleWedge-Cage in...

Guided Therapeutics Receives Notification of Successful Clinical Trial Regulatory Review and...

Asensus Surgical Receives FDA 510(k) Clearance for Articulating Instruments

NuVasive receives CE Mark for Pulse platform and begins global clinical...

Elekta radiotherapy system designed for changing cancer landscape now available for...

Quidel Receives Amended Emergency Use Authorization for New Sofia® Q Rapid...

Empatica gets CE mark for EmbracePlus medical smartwatch

Chemence Medical’s redesigned skin closure system approved by FDA

LimFlow Receives Japan PMDA Approval for Clinical Study of Minimally-Invasive Technology...

Bruno Vision Care receives FDA approval for Deseyne Contact Lens with FusionTechnology

FDA grants 510(k) clearance to Turbett Surgical’s Instrument Pods

FDA clears first stapler for single-port robotics from Intuitive

Innoblative wins FDA IDE for electrosurgical device for breast cancer treatment

FDA clears NeurAxis’ self-inflating balloon device RED

Guided Solutions Appoints Marco Müller as New Managing Director Germany to Drive Strategic Growth

Guided Solutions Appoints Manu Chhokra as Managing Director for Switzerland

FDA clears portable blood, IV fluid warmer from Mequ