Regulatory Approvals

Waypoint Orthopedics seeks FDA 510(k) approval for smart bone awl

The system provides visual feedback regarding the location of the probe and reduces radiation exposure during surgery. Spinal instrumentation firm Waypoint Orthopedics has submitted an application seeking...

DyAnsys receives US FDA approval for First Relief neurostimulation device

First Relief is placed behind the ear and provides continuous pulses of low-level electrical current. DyAnsys has received US Food and Drug Administration (FDA) approval for its...

FDA clears Healthy.io’s smartphone-based AI test for early-stage kidney disease

At-home diagnostics have been a crucial weapon in the war against the COVID-19 pandemic, and after proving their mettle on that battlefield, they’re now...

Ancora Heart Receives Breakthrough Device Designation from FDA for the AccuCinch® Ventricular Restoration System

Ancora Heart, Inc., a company developing a novel device-based therapy to address heart failure, announced that the U.S. Food and Drug Administration (FDA) has...

Stereotaxis Announces CE Mark Submission for Robotically Navigated MAGiC Catheter

Stereotaxis has announced the CE Mark submission for its MAGiC™ catheter. The MAGiC catheter is a robotically navigated magnetic interventional ablation catheter for minimally invasive...

Nyxoah receives FDA approval to begin Genio system trial

The trial will assess the use of the Genio system to treat moderate to severe OSA and CCC in adult patients. Medical technology firm Nyxoah...

Renovia receives FDA clearance for leva® Pelvic Health System as first-line treatment for chronic fecal incontinence

Renovia Inc. ("Renovia"), a developer of non-surgical, treatments for female pelvic floor disorders and an advocate for women's health, announced that the U.S....

Ra Medical Systems Receives FDA 510(k) Clearance for the DABRA 2.0 Catheter

Ra Medical Systems, Inc. (NYSE American: RMED)(“Ra Medical” or the “Company”), a medical device company focusing on developing its excimer laser system to treat...

ResApp gets 510(k) clearance for mobile sleep apnoea test SleepCheck

It has been approved as a prescription-only software-as-a-medical device in the US. ASX-listed ResApp Health has received the US Food and Drug Administration's 510(k) clearance...
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