Regulatory Approvals

FDA grants 510(k) clearance to TaeWoong Medical for Spaxus EUS stent

May 5, 2026

Cardio Flow receives US FDA clearance for FreedomFlow platform

October 20, 2023

Cardio Flow has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its FreedomFlow Orbital Atherectomy Peripheral Platform. The platform deploys a...

Praxis Medical Announces FDA Clearance of the EndoCore EBUS-TBNA Biopsy Device

October 18, 2023

Praxis Medical announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of the EndoCore EBUS-TBNA fine needle biopsy device. Endobronchial ultrasound with...

Heidelberg’s ANTERION platform gets US FDA approval

October 18, 2023

Ophthalmic imaging company Heidelberg Engineering has secured US Food and Drug Administration (FDA) clearance for its ANTERION platform. ANTERION is an all-in-one upgradeable platform to transform...

FDA grants 510(k) clearance to Werfen for Aptiva CTD Essential reagent

October 18, 2023

Werfen has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Aptiva Connective Tissue Disease (CTD) Essential reagent. A fully automated multi-analyte system,...

Masimo gets de novo approval from FDA for ORi

October 17, 2023

Masimo has received de novo approval from the US Food and Drug Administration (FDA) for ORi, its noninvasive, continuous parameter that delivers additional insight into a patient’s...

FDA clears Establishment Labs’ magnetic-free breast tissue expander

October 17, 2023

The US Food and Drug Administration (FDA) has cleared Establishment Labs’ tissue expander for breast reconstruction surgery. In a statement announcing the news, the US-headquartered company said...

FDA creates new advisory committee for digital health and AI

October 13, 2023

As the wave of digitalisation sweeping across healthcare becomes more prevalent, the US Food and Drug Administration (FDA) has established a new advisory committee...

Device utilising sound to destroy tumors gets greenlight from FDA

October 13, 2023

US-based histotripsy therapy firm has been given the green light by the US Food and Drug Administration (FDA) to bring its device that uses...

TechMah CMF’s new tmCMF Solution receives US FDA clearance

October 12, 2023

TechMah CMF has received US Food and Drug Administration 510(k) clearance for its new medical device, the tmCMF Solution. The new device includes personalised product solutions for...

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FDA grants 510(k) clearance to TaeWoong Medical for Spaxus EUS stent

Agitated Solutions wins CE mark for cardiac microbubble generator device

Motif Neurotech wins FDA IDE to evaluate brain implant for treating depression

BrioHealth gets conditional FDA nod for pediatric ventricular assist device study

MMI completes first robotic-assisted procedure in Alzheimer’s patient

CVRx enrolls first patient in study of Barostim therapy for heart failure

Sensome reports positive findings for clot-sensing guidewire

CorTec’s Brain Interchange BCI system enables stroke patient to control computer with his mind

Neuvotion to launch neurostim for post-stroke recovery

Reflow Medical launches next-gen microcatheters

Egg Medical unveils new radiation protection system for clinical use

Starlight Cardiovascular reports first baby treated with Lifeline system

CareDx sharpens precision medicine focus with $260M Naveris acquisition

Stereotaxis announces definitive agreement to acquire Robocath

Sectra completes Oxipit acquisition, accelerating autonomous AI in radiology

Avanos Medical agrees to be acquired by American Industrial Partners

Apollo investment supports vVARDIS’s global Curodont expansion

Senseonics announces $80M public offering

Trinity Capital provides $30M in growth capital to Iantrek

Hypervision raises $23M Series A for hyperspectral surgical imaging tech

Regulatory Approvals

FDA grants 510(k) clearance to TaeWoong Medical for Spaxus EUS stent

MMI completes first robotic-assisted procedure in Alzheimer’s patient

Apollo investment supports vVARDIS’s global Curodont expansion

FDA grants 510(k) clearance to TaeWoong Medical for Spaxus EUS stent

CVRx enrolls first patient in study of Barostim therapy for heart failure

MMI completes first robotic-assisted procedure in Alzheimer’s patient

Apollo investment supports vVARDIS’s global Curodont expansion

FDA grants 510(k) clearance to TaeWoong Medical for Spaxus EUS stent

CVRx enrolls first patient in study of Barostim therapy for heart failure

Guided Solutions Celebrates 25 Years of Transforming Executive Search in MedTech

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