Perfuze yesterday announced that the FDA granted its Millipede CIS technology Breakthrough Device Designation. Millipede CIS is a catheter technology that removes clots from the brain after an acute ischemic stroke. The Breakthrough Device Designation was granted based on its potential to offer advantages over other alternative treatment of acute ischemic stroke, according to the […]
Alphatec launches SingleStep implant delivery system
Alphatec (NSDQ:ATEC) yesterday announced the commercial launch of its InVictus minimally invasive SingleStep K-wireless implant delivery system. SingleStep eliminates the requirement for K-wires in percutaneous pedicle fixation procedures and reduces potential complications that can occur with inadvertent K-wire advancement in traditional minimally invasive pedicle screw placement technique. Instead, the Alphatec system uses an all-in-one driver that […]
NinePoint Medical wins FDA clearance for NvisionVLE
NinePoint Medical yesterday announced that it received FDA clearance for its NvisionVLE Imaging System for use in the pancreases and bile duct. The NvisionVLE Imaging System gives physicians real-time, high-resolution volumetric images of tissue surfaces and subsurfaces, according to the company. The new clearance adds on to the already existing indications for esophageal applications in […]
Australian TGA issues final guidance on medical device and IVD cybersecurity
By Stewart Eisenhart, Emergo Group Australia’s Therapeutic Goods Administration (TGA) has implemented final guidance on pre- and post-market cybersecurity regulatory recommendations for medical device, software and IVD manufacturers and sponsors. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily […]
ExThera Medical wins CE Mark approval for blood filter
ExThera Medical yesterday said it received CE Mark approval for is Seraph 100 Microbind Affinity Blood Filter. The Seraph 100 is designed to reduce pathogens during bloodstream infections and the CE Mark allows the filter to be used as an adjunct to anti-infective therapy. ExThera’s filter quickly lowers the concentration of bacteria, viruses and fungi […]
Avanos Medical beats the Street in Q2 results
Avanos Medical (NYSE:AVNS) posted second-quarter results yesterday that beat the consensus on Wall Street and increased its sales growth outlook for the rest of 2019. The Alpharetta, Ga.-based company reported a net loss of -$8 million, or -17¢ per share, on sales of $172.2 million for the three months ended June 30, 2019. At this time […]
New European MDR guidance on medical device implant cards
By Ronald Boumans, Emergo Group The European Medical Device Coordination Group (MDCG) has adopted a guidance document on implant cards, assisting in understanding article 18 of the Medical Devices Regulation (EU) 2017/745 (MDR). Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]
FDA approves Endotronix trial for Cordella PA pressure sensor
Endotronix last week announced that it received FDA approval to begin its multi-center Proactive-HF trial of the Cordella Pulmonary Artery Pressure Sensor System. The trial is designed to help the Cordella Sensor reach pre-market approval faster and will begin enrollment in the third quarter of 2019. “We are excited to begin enrollment in this groundbreaking […]
Cardiovascular Systems acquires Gardia Medical’s embolic protection system
Cardiovascular Systems (NSDQ:CSII) yesterday announced that it acquired the Wirion Embolic Protection System and its related assets from Gardia Medical for $5.6 million. Cardiovascular Systems paid $5.6 million for the system and $1.5 million will be held in escrow until the 12 months following a successful manufacturing transfer. The company also issued Gardia 31,493 shares of […]
IceCure Medical wins Israeli AMAR approval for tumor freezing technology
IceCure Medical yesterday said it received Israeli AMAR authorization to use its freezing technology in specific indications. The approval will allow the Israel-based company to use the technology to freeze benign and malignant tumors, including breast, lungs, bones, liver, lymphatic tissue, lymph nodes and endocrine glands. “This specific approval in Israel is an important achievement […]
Brazil regulators require electronic submission of medical device FSCAs
By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA has begun requiring manufacturers and sponsors to provide field safety corrective action information via an electronic petitioning system. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect […]