FDA 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

Featured

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: FDA approval

First daytime treatment for obstructive sleep apnea receives De Novo authorization

OrthoSpin Gains FDA Clearance for G2 System

Imagio Opto-Acoustic Imaging for Breast Lesions

DePuy Synthes Receives 510(k) FDA Clearance for VELYS™

Cognito Therapeutics nets FDA breakthrough label for light, sound therapy for...

AI decision support tool receives FDA clearance

Quanta nets FDA clearance for its portable dialysis system

Accuray Receives 510(k) FDA Clearance for ClearRT™ Helical kVCT Imaging for...

FDA Clears Device to Remove Dead Pancreatic Tissue

Medtronic gets FDA Clearance for Midas Rex™ Drills with Mazor™ Robotic...

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