Ra Medical Systems Inc., of Carlsbad, Calif., reported that the U.S. FDA has granted investigational device exemption (IDE) approval to study its DABRA excimer laser system as an atherectomy device to treat peripheral vascular stenosis.
Dublin-based Medtronic plc has snagged the U.S. FDA’s approval for its Micra AV, the world’s smallest pacemaker with atrioventricular (AV) synchrony. The company said it will begin rolling out the device at a limited number of medical centers in the upcoming weeks, with a full, nationwide launch sometime this spring. About the size of a large vitamin pill, the leadless Micra AV is indicated for the treatment of patients with AV block, a disorder that occurs when the electrical signal traveling from the atria, or upper chambers of the heart, to the ventricles, or lower chambers, is impaired.
Novocure Ltd. of St. Helier, Jersey, released preliminary fourth-quarter and full-year 2019 results, showing strong momentum with its tumor treating fields (TTF) technology, a noninvasive, antimitotic therapy delivered via the Optune device. Q4 revenue is expected to hit $99.2 million, up 42% from $69.7 million in the same period last year, with anticipated full-year revenue of $351.3 million, also up 42%. In the U.S., net revenues grew 49% to $65.9 million in the last financial quarter.
Boulder, Colo.-based startup Arpeggio Biosciences Inc. scooped up $3.2 million in seed funding in a round led by Khosla Ventures, with participation by Fundersclub, Fifty Years, TechU and Y Combinator.
The U.S. FDA has granted breakthrough device designation to Mojo Vision Inc. for its first-of-a-kind true smart contact lens. The Mojo Lens, which features “invisible computing” and a built-in display, enables people to get timely information without having to look away from what they are doing or glance at a screen.
Boulder, Colo.-based startup Arpeggio Biosciences Inc. scooped up $3.2 million in seed funding in a round led by Khosla Ventures, with participation by Fundersclub, Fifty Years, TechU and Y Combinator.
Transenterix Inc., of Research Triangle Park, N.C., said Tuesday that it has filed a 510(k) submission with the U.S. FDA for the Intelligent Surgical Unit (ISU), a machine vision system designed to work with its robotic Senhance surgical system. The new technology would equip users of the Senhance system with augmented intelligence to improve performance and surgical outcomes.
Artificial intelligence (AI) health care startup Cardiologs Technologies SAS scooped up $15 million in a series A funding round led by Alven Capital Partners. The Paris-based company, which has an artificial intelligence-based platform to quickly diagnose cardiac arrhythmias, plans to use the money to grow its sales and marketing efforts across North America and Europe. The funds will also be used to advance the platform’s capabilities. Also participating in the financing were previous investors Bpifrance, Isai, Kurma Diagnostics, Idinvest Partners and Paris Saclay Seed Fund.