Regulatory Approvals

FDA clears Atreon’s bioresorbable synthetic implant for rotator cuff repair

February 24, 2025

RedDrop Dx wins FDA approval for RedDrop One blood collection device

March 25, 2024

US-based medical equipment manufacturer RedDrop Dx has received the US Food and Drug Administration (FDA) 510(k) approval for its advanced blood collection device, RedDrop...

Elixir Medical wins FDA breakthrough designation for DynamX BTK implant

March 22, 2024

Elixir Medical today announced it received FDA breakthrough device designation for its DynamX BTK system for treating chronic limb-threatening ischemia. The Milpitas, California-based company...

Butterfly Network wins CE mark for IQ+ handheld ultrasound tech, hopes for next-gen nod this year

March 21, 2024

Butterfly Network (NYSE:BFLY) announced today that it garnered CE mark approval for its Butterfly iQ+ ultrasound system.The company obtained European Union Medical Device Regulation...

inHEART Receives FDA Clearance for Advanced AI-driven Software Module That Optimizes the Creation of 3D Models of the Heart

March 21, 2024

inHEART, a privately-held medical device company delivering the world's most advanced, AI-driven digital twin of the heart, announced today that it has received FDA...

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OrganOx completes $142m equity financing led by HealthQuest Capital

Trinity Capital provides $15m in growth capital to Cagent Vascular

Valencia Technologies raises $35m for coin-sized neuromod device

VitalConnect reels in $100m investment to expand patient monitoring products

WhiteSwell has positive data for its fluid removal system eLym

MicroTransponder Vivistim nerve stim tech delivers positive stroke outcomes

Wellumio’s portable MRI device trial enrols first subject in Australia

ScreenPoint’s AI breast cancer screening tool hits detection success in new study

UroMems reports positive outcomes in first-ever female-only study of smart implant for incontinence

BetaGlue enters exclusive global agreement with Artivion for BioGlue

Plexāā secures manufacturing deal for breast cancer surgery prep device

Fractyl Health to focus on Revita and Rejuva Programs

FDA clears Atreon’s bioresorbable synthetic implant for rotator cuff repair

CathVision’s ECGenius system gains CE Mark, enabling European distribution

QuantalX’s brain health assessment device gains CE MDR approval

Neuvotion wins FDA 510(k) clearance for NeuStim neuromod wearable

Globus Medical to acquire Nevro for $250m to expand treatment options

Zimmer Biomet announces definitive agreement to acquire Paragon 28

Kaneka acquires EndoStream Medical

Boston Scientific to acquire remaining ownership stake in Bolt Medical for $664m

Regulatory Approvals

FDA clears Atreon’s bioresorbable synthetic implant for rotator cuff repair

Siemens Healthineers and Sectra strike radiology partnership

OrganOx completes $142m equity financing led by HealthQuest Capital

UroMems reports positive outcomes in first-ever female-only study of smart implant for incontinence

Trinity Capital provides $15m in growth capital to Cagent Vascular

Siemens Healthineers and Sectra strike radiology partnership

OrganOx completes $142m equity financing led by HealthQuest Capital

UroMems reports positive outcomes in first-ever female-only study of smart implant for incontinence

Trinity Capital provides $15m in growth capital to Cagent Vascular

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