Avalign and its Instrumed International subsidiary agreed to pay $9.5 million to settle federal charges that it sold medical devices that weren’t cleared for the U.S. market. The case, which has already cost Instrumed distributor CareFusion $3.3 million, involves devices that Instrumed claimed as pre-amendment devices that were exempt from FDA regulations instituted in May 1976. […]
Ex-Bard CEO Ring surfaces with $30m medtech fund for low-resource areas
Tim Ring, who led C.R. Bard to a $24 billion acquisition by Becton Dickinson (NYSE:BDX) nearly two years ago, is the co-founder of a new $30 million fund aimed at medical device companies developing products for low-resource geographies. TEAMFund – the “TEAM” stands for “Transforming Equity and Access for Medtech” – is the brainchild of Ring […]
Danaher dental spinout Envista prices $589m IPO
Envista (NYSE:NVST), the dental business spinout from Danaher (NYSE:DHR), yesterday priced its initial public offering at $589 million, sending its overall valuation well above the $3 billion mark. The spinout, announced in July 2018, will unite the Nobel Biocare, KaVo Kerr and Ormco dental brands under the Envista umbrella. The nearly 26.8-million-share flotation, at $22 per share, is for […]
Zimmer Biomet warns on Rosa Brain robot software issue
Zimmer Biomet (NYSE:ZBH) last week warned of a software glitch with its Rosa Brain 3.0 devices for robot-assisted neurosurgery procedures. No long-term adverse events were reported from the problem, in which a sequence workflow can trigger “a discrepancy between initial skin marking on the skull and instrument trajectory,” the Warsaw, Ind.-based company said. “In all […]
KFx defeats Stryker challenge to shoulder anchor patent
UPDATED Sept. 18, 2019, with additional inter partes win for KFx. KFx Medical yesterday defeated a challenge by Stryker (NYSE:SYK) to one of its patents covering orthopedic suture anchors when the U.S. Patent Trial & Appeals board declined to initiate an inter partes review. U.S. patent no. 7,585,311, covering a “System and method for attaching […]
Bayer leads One Drop’s $40m Series B, inks deal to expand past diabetes
Bayer (ETR:BAYN) led a $40 million Series B round for glucose monitor maker One Drop, licensed its platform for treating conditions beyond diabetes and put its pharma president on the One Drop board. New York City-based One Drop developed a compact blood glucose monitor, pairing it with an app designed to provide behavioral cues and one-on-one coaching. […]
CMR Surgical drums up another $243 million for Versius robotic surgery device
CMR Surgical said today that it raised some $243 million in a Series C round it plans to use to commercialize its Versius robot-assisted surgery device. The Cambridge, U.K.-based company said the £195 million round (worth about $242.8 million) is Europe’s largest private medtech financing to date. CMR Surgical, formerly known as Cambridge Medical Robotics, […]
Danaher dental spinout Envista preps $600m IPO
The dental business spinout at Danaher (NYSE:DHR), Envista, is gearing up for a $600 million initial public offering this week. The spinout, announced in July 2018, will unite the Nobel Biocare, KaVo Kerr and Ormco dental brands under the Envista umbrella. The newly public company, which employs some 12,000 workers, is headquartered in Brea, Calif. Envista […]
Medsil warns on aspiration risk with intragastric balloon
Medsil last month warned of the risk of fluid aspiration if its intragastric balloon isn’t deployed according to its instructions for use. The Russian company sent a letter to physicians dated August 20 indicating that the silicon used to make the balloon can degrade if exposed too long to the stomach’s hydrochloric acid. The device […]
Saluda Medical wins CE Mark for Evoke closed-loop SCS
Saluda Medical said today that it won CE Mark approval in the European Union for its Evoke closed-loop spinal cord stimulation device. Australia- and Bloomington, Minn.-based Saluda, which is backed by both Boston Scientific and Medtronic, said the first commercial implantations have already occurred, in Holland. The Evoke device is designed to measure the response […]
Innoblative taps ex-Lumicell chief Londy for CEO | Personnel Moves, Sept. 13, 2019
Innoblative Designs last week named former Lumicell chief executive Kelly Londy as its new CEO. Apart from her two-year stint at the Lumicell helm, Londy was COO at Accuray (NSDQ:ARAY) and worked at GE Healthcare and Philips Healthcare. “Innoblative’s Sira RF ablation device offers unique capabilities that address shortcomings in the current advanced energy surgical market,” […]
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