xDot Medical can begin FDA IDE study of vascular closure device

Regulatory Approvals
xDot Medical has received FDA investigational device exemption (IDE) approval to begin a pivotal clinical trial of its Access Management System (AMS) for closing large-bore femoral arterial and venous access sites following catheter-based procedures. The...

xDot Medical can begin FDA IDE study of vascular closure device

Regulatory Approvals
xDot Medical has received FDA investigational device exemption (IDE) approval to begin a pivotal clinical trial of its Access Management System (AMS) for closing...

Movmedix gets FDA nod for third-gen synthetic shoulder implant

Regulatory Approvals
Movmedix has received FDA 510(k) clearance for its third-generation LARS ACJ synthetic ligament implant, marking the company's first U.S. regulatory approval and enabling the...

Neo Medical launches access platform for minimally invasive spine surgery

Innovation
Neo Medical has launched its Neo Instant MIS Access platform in the United States, expanding its minimally invasive spine surgery offering for thoracic, lumbar,...

First patient enrolled in study of Reflow Medical’s Spur system

Clinical Trials
Reflow Medical has enrolled the first patient in the DEEPER CHALLENGE study evaluating its Spur Peripheral Retrievable Scaffold System for below-the-knee treatment in patients...

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Clinical Trials

First patient enrolled in study of Reflow Medical’s Spur system

Reflow Medical has enrolled the first patient in the DEEPER CHALLENGE study evaluating its Spur Peripheral Retrievable Scaffold System for below-the-knee treatment in patients...

Francis Medical announces publication of VAPOR 2 pivotal trial results

Francis Medical has published the initial report of its VAPOR 2 pivotal clinical study in The Journal of Urology, showcasing highly positive results for...

Coherence Neuro begins first clinical study for BCI

Coherence Neuro has initiated its first clinical study of the investigational Cipher brain-computer interface (BCI), marking its transition into human testing. The study, led by...

Imperative Care reports SYMPHONY-PE trial data for pulmonary embolism

Imperative Care has reported results from a post-hoc analysis of the SYMPHONY-PE trial, evaluating the impact of early mechanical thrombectomy in patients with intermediate-risk...

Innovation

Regulatory Approvals

xDot Medical can begin FDA IDE study of vascular closure device

xDot Medical has received FDA investigational device exemption (IDE) approval to begin a pivotal clinical trial of its Access Management System (AMS) for closing...

Movmedix gets FDA nod for third-gen synthetic shoulder implant

Movmedix has received FDA 510(k) clearance for its third-generation LARS ACJ synthetic ligament implant, marking the company's first U.S. regulatory approval and enabling the...

Neo Medical launches access platform for minimally invasive spine surgery

Neo Medical has launched its Neo Instant MIS Access platform in the United States, expanding its minimally invasive spine surgery offering for thoracic, lumbar,...

First patient enrolled in study of Reflow Medical’s Spur system

Reflow Medical has enrolled the first patient in the DEEPER CHALLENGE study evaluating its Spur Peripheral Retrievable Scaffold System for below-the-knee treatment in patients...

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