BD wins FDA nod for breast biopsy, tissue removal system
January 15, 2026
BD (NYSE: BDX)+
announced today that the FDA granted 510(k) clearance for its EnCore EnCompass breast biopsy and tissue removal system.
BD (NYSE: BDX)+
announced today that the FDA granted 510(k) clearance for its EnCore EnCompass breast biopsy and tissue removal system.
EndoQuest Robotics announced today that the FDA approved the initiation of the next and final stage of its PARADIGM trial.
IotaMotion announced today that it received FDA 510(k) clearance for expanded pediatric use of its iotaSoft insertion system.
Boston Scientific (NYSE: BSX)+
announced that it received CE mark approval for its Embold detachable coil system.
A Boston Scientific (NYSE: BSX)+
executive said on social media that the company received FDA approval for its Farapoint pulsed field ablation (PFA) catheter.
AliveCor announced today that it received FDA clearance for the next generation of its AI technology for the Kardia 12L ECG system.
Minneapolis-based Imricor Medical Systems (ASX:IMR) said it won 510(k) clearance from the FDA for its Vision-MR Diagnostic Catheter.
SINGAPORE, Jan. 6, 2026 /PRNewswire/ — Spectrumedics Medical (hereinafter “Spectrumedics”) is pleased to announce that its Sonico-CX Intravascular Lithotripsy (IVL) System has obtained CE Mark certification under the European Union Medical Device Regulation (EU MDR). The system comprises the Sonico-CX Coronary Intravascular Lithotripsy Catheter and the Intravascular Lithotripsy Generator.
SAN JOSE, Calif., Jan. 15, 2026 /PRNewswire/ — LEADOPTIK, Inc. today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its Last Inch Assessment™ (LIA) system, the world’s first system to use silicon photonics imaging technology and software designed to improve the accuracy of lung biopsy procedures.
CORAL SPRINGS, Fla., Jan. 12, 2026 /PRNewswire/ — Neurolief Inc., a medical device company focused on neuromodulation therapies for neuropsychiatric conditions, today announced that the U.S. Food and Drug Administration (FDA) has approved Proliv™Rx, the first prescription, physician-directed, at-home brain neuromodulation therapy as an adjunctive treatment for adults with Major Depressive Disorder (MDD) who failed to achieve satisfactory improvement from at least one previous antidepressant medication.