Dublin-based Medtronic plc’s Micra pacemaker was a groundbreaking device when the FDA approved the leadless pacemaker in 2016, thanks to the elimination of the hazards associated with pacemaker leads. However, the FDA said recently that the risks associated with cardiac perforation with leadless pacemakers, such as tamponade or death, might be higher with the Micra than with pacemakers with leads.
LONDON – The first commercial implantations of Istar Medical SA’s minimally invasive Miniject supraciliary glaucoma drainage device have taken place in Germany, following European CE approval for the product.
Assure Tech (Hangzhou) Co. Ltd. made its debut on the Shanghai Stock Exchange Star Market and raised ¥1.2 billion (US$188 million) in the IPO. Its shares increased 19.28% in the middle of the first trading day but closed 6.73% lower the second day.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Datar Cancer Genetics.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bruker, Hls Therapeutics, Ion Beam Applications, Molecubes, Mynd Diagnostics, Saladax.
Sense Biodetection Ltd. closed a $65 million series B investment round on a high note with an additional $15 million pouring in from previous investors. The Abingdon, England-based company raised $50 million in a first tranche of the round in April. Koch Disruptive Technologies LLC, a subsidiary of Koch Industries Inc., led both parts of the round.