Lumicell said it completed enrollment in a Phase C feasibility clinical trial for its intraoperative breast cancer imaging system. The Newton, Mass.-based company expects results later this year and plans to start a pivotal trial by the end of 2019 before it applies for FDA approval. Lumicell’s imaging system is designed to enable surgeons to […]
CVRx’s Barostim Neo system earns FDA approval
CVRx said today it won FDA approval for its Barostim Neo system, the world’s first heart failure neuromodulation device. The Minneapolis-based company’s device is designed to improve symptoms in patients with advanced heart failure who are not suited for other heart failure devices by electrically activating the baroreflex to reduce sympathetic activity and increase parasympathetic […]
FDA approves Zimmer Biomet’s pediatric spinal tether for scoliosis
Zimmer Biomet (NYSE:ZBH) said it received the first FDA approval for a spinal tether device intended to correct pediatric scoliosis. Warsaw, Ind.-based Zimmer Biomet’s tether is an anterior vertebral body tethering solution that uses a flexible cord as an alternative to metal rods. The cord is designed to pull on the outside of a scoliosis […]
Nexxt Spine wins clearance for Matrixx stand-alone cervical implant
Nexxt Spine said last week that it won 510(k) clearance from the FDA for its Nexxt Matrixx stand-alone cervical system. The anterior cervical interbody fusion system is used for the treatment of degenerative disc disease. The device will be used with the bone screw fixation provided and requires no additional fixation. Nexxt Spine said it’s […]
Hearing Industries Assn. protests FDA clearance of Bose self-fitted hearing aid
The Hearing Industries Assn. conveyed its concerns with the FDA’s approval of Bose Corp.’s self-fitting hearing aid. In October 2018, the FDA granted Bose de novo clearance for the over-the-counter device billed as the first of its kind on the U.S. market, according to the FDA’s Center for Devices & Radiological Health. In a May […]
SofWave Medical closes $8.4 million financing round, announces Louis Scafuri as CEO
SofWave Medical secured an $8.4 million financing round, led by co-founder and chairman Shimon Eckhouse and XT Hi-Tech, as the Israeli-based company develops non-invasive fractional ultrasound technology for skin tightening. “This financing round of SofWave Medical will enable us to execute aggressively on our plan to build and position the company as a leader in […]
Ascyrus Medical wins breakthrough for dissection stent graft
Ascyrus Medical said today that it received breakthrough device designation from the FDA for the stent graft it developed to treat abdominal aortic dissections. The AMDS device is designed to treat acute Type A aortic dissections, in which the lining of the abdominal aorta becomes detached from the wall of the vessel. Ascyrus won CE […]
Medtronic readies device to rival Intuitive Surgical’s da Vinci SP
Medtronic (NYSE:MDT) is reportedly developing a soft tissue surgical device to rival the da Vinci SP robot-assisted surgery platform made by Intuitive Surgical (NSDQ:ISRG). Bernstein analyst Lee Hambright, writing today in a note to investors, said Fridley, Minn.-based Medtronic is slated to reveal the device during its Sept. 24 analyst day, according to Seeking Alpha. The […]
Tevosol closes $1.5 million in new round of seed funding
Tevosol said yesterday that it added another $1.5 million in seed financing for the portable organ perfusion device it’s developing. Edmonton, Alberta-based Tevosol said the proceeds from the C$2 million round are earmarked for a proof-of concept human trial at the University of Alberta for its ex-vivo organ support system, expansion of its engineering, industrial […]
ZipLine Medical touts Zip incision closure studies
ZipLine Medical touted a pair of studies highlighting the positives of its noninvasive Zip surgical skin closure device as an alternative to traditional staples. The first study, by Dr. Roger Emerson of the Texas Center for Joint Replacement in Plano, compared 65 total knee arthroplasty patients treated with the Zip device with 65 subjects treated […]
Second Heart Assist picks up $4m
Second Heart Assist yesterday filed an SEC Form D revealing that it sold more than $4 million in equity. The filing, which totaled approximately $4.1 million, was classified as a new notice, with the first sale made Dec. 31, 2016. Second Heart Assist labeled both the total offering amount and the total remaining to be […]
