Regulatory Approvals

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

April 15, 2025

FDA clears Epitel remote monitoring tech, AI detection platform

April 24, 2024

Epitel announced received FDA 510(k) clearance for two new patient-focused brain health offerings. The FDA cleared the Remi remote EEG monitoring system for ambulatory...

Pantheon meets with FDA to discuss PMA submission for corneal implants

April 22, 2024

Pantheon Vision has completed two pre-submission meetings with the US Food and Drug Administration (FDA) as the company looks to advance its corneal implants...

FDA approves Lumicell’s breast cancer visualization system

April 22, 2024

Lumicell today announced it received FDA approval for its LumiSystem direct visualization system for breast cancer removal. According to the company, the LumiSystem allows surgeons...

FDA approves XStim spine fusion stimulator

April 17, 2024

Xstim announced today that it received premarket approval from the FDA for its Xstim spine fusion stimulator device.Irving, Texas-based Xstim designed its capacitively coupled...

Adherium’s Smartinhaler gains clearance for use with AstraZeneca devices

April 16, 2024

Adherium has obtained US Food and Drug Administration (FDA) clearance for the use of its Hailie Smartinhaler with AstraZeneca’s Airsupra and Breztri inhalation devices. This...

IceCure submits final breast cancer cryoablation data to FDA

April 16, 2024

IceCure Medical announced it submitted final data to the FDA requesting marketing authorization for its ProSense system. Caesarea, Israel-based IceCure designed ProSense to deliver...

Onkos Surgical Announces First FDA De Novo Approval of an Antibacterial Coating for Tumor and Revision Orthopaedic Implants

April 11, 2024

Onkos Surgical, an orthopaedic company founded to address the complex clinical challenges associated with bone loss due to tumor, trauma, and revision surgery, announced that...

FDA issues 510(k) clearance for twiist insulin system

April 10, 2024

DEKA Research & Development has received 510(k) clearance from the US Food and Drug Administration (FDA) for the twiist automated insulin delivery (AID) system. The...

FDA clears first over-the-counter wearable glucose tracker, with Dexcom’s Stelo

April 10, 2024

The FDA has cleared its first over-the-counter wearable blood sugar tracker, with Dexcom’s slimmed-down Stelo continuous glucose monitor. Related: Orthobond wins FDA de novo approval...

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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