Regulatory Approvals Archives

Regulatory Approvals

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

April 15, 2025

Hologic gets CE mark for Genius digital diagnostics system

November 19, 2020

The platform is designed to help cytotechnologists and pathologists detect pre-cancerous lesions and cancer cells in women Genius digital diagnostics system for cervical cancer...

Nanowear Receives FDA 510(k) Clearance for SimpleSENSE

November 16, 2020

SimpleSENSE provides a continuous, simultaneous, and synchronous assessment of the heart, lungs, and upper vascular system without the need for an in-person doctor's visit. Nanowear www.nanowearinc.com,...

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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

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

Regulatory Approvals

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

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

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