Regulatory Approvals

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

April 15, 2025

Axena secures new HCPCS code for Leva Pelvic Health System

March 5, 2024

Axena Health has announced that its Leva Pelvic Health System received a new Healthcare Common Procedure Coding System (HCPCS) Level II code from the...

FDA Clears AIOMEGA’s AIO Breathe, for Treatment of Obstructive Sleep Apnea

March 1, 2024

AIOMEGA, a Texas biomedical company, announced that AIO BREATHE, their medical device that treats Obstructive Sleep Apnea, has been cleared by the Food and...

New Soldier® High Flow Microcatheter Granted FDA Clearance

March 1, 2024

Embolx Inc., a leading medical technology company developing microcatheters for arterial embolization procedures, is thrilled to announce that the U.S. Food and Drug Administration...

Spectral AI’s DeepView software secures UKCA authorisation

February 27, 2024

Spectral AI has received UK Conformity Assessed (UKCA) authorisation for its DeepView AI-Burn predictive software. The authorisation allows the system to aid in burn wound...

Virtual Incision secures FDA authorisation for MIRA Surgical System

February 27, 2024

Virtual Incision has received the US Food and Drug Administration (FDA) marketing authorisation of the MIRA Surgical System (MIRA) for colectomy procedures in adults. MIRA...

SeaStar’s device granted humanitarian exemption approval for children with AKI

February 27, 2024

Following positive clinical results, the US Food Drug Administration (FDA) has granted SeaStar Medical a humanitarian device exemption (HDE) approval for its Quelimmune selective...

IMRIS, Deerfield Imaging Receives FDA Clearance for the InVision 1.5 Surgical Theatre

February 26, 2024

IMRIS, Deerfield Imaging, the global leader in intraoperative imaging, announced that the company has received 510(k) clearance from the U.S. Food and Drug Administration...

Momentum scores FDA clearance for remote monitoring scoliosis app

February 22, 2024

Canadian company Momentum Health has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Momentum Spine app for remote monitoring...

CALCIVIS® to Launch Revolutionary New Bioluminescent Dental Imaging System in the US After Securing Final Stage Food and Drug Administration Pre-Market Approval

February 20, 2024

Calcivis is launching its groundbreaking new preventive dental technology in the United States. The business filed a PMA supplement with the FDA for enhancements...

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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

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