ClearPoint Neuro up on FDA clearance for partner's laser therapy system

Clinical Laserthermia Systems AB

23/09/2022 17:24

** Shares of ClearPoint Neuro Inc  CLPT.O  rise 3.4% to
$10.45 in afternoon trade
    ** Co says its Swedish partner, Clinical Laserthermia
Systems (CLS), has received U.S. FDA's 510(k) clearance for its
laser that the co plans to commercialize as ClearPoint Prism
Neuro Laser Therapy System  urn:newsml:reuters.com:*:nGNX5lkhyv
    ** System is indicated for use to coagulate soft tissue
through a thermal therapy with help from magnetic resonance
imaging (MRI) in neurosurgery
    ** Under 510(k) clearance process, medical device
manufacturers need to notify FDA at least 90 days in advance of
their intent to market a device
    ** Therapy system is currently in limited market release at
select academic medical centers in the U.S.
    ** Including session's gain, stock down ~7% YTD
 (Reporting by Raghav Mahobe)
 ((Raghav.Mahobe@thomsonreuters.com;))