The U.S. Securities & Exchange Commission is reportedly investigating three of the world’s largest medical device makers for their alleged participation in a bribery scheme in China. The SEC probe involves Siemens (NYSE:SI), Royal Philips (NYSE:PHG) and GE Healthcare (NYSE:GE), which allegedly used local middlemen to bribe Chinese government and hospital officials to buy their medical equipment, Reuters reported, […]
Edwards Lifesciences warns against below-market mini-tender offer
Edwards Lifesciences (NYSE:EW) yesterday advised its investors against joining in an unsolicited “mini-tender offer” by TRC Capital Corporation, which is looking to purchase approximately 1 million shares of the company’s stock. The Irvine, Calif.-based company said it does not endorse the offering and recommended that its stockholders “reject the offer” either by doing nothing in response […]
J&J’s Ethicon files ITC complaint against Intuitive Surgical
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon wants the U.S. International Trade Commission to stop Intuitive Surgical (NSDQ:ISRG) from importing robot-assisted surgical staplers it makes in Mexico, alleging that they infringe a quintet of Ethicon patents. In a complaint filed with the ITC last week, Ethicon accused Intuitive’s EndoWrist and SureForm endocutters of infringing five of its […]
Auris Health loses motion to move Intuitive Surgical patent suit from Del. to Cali.
Newly Johnson & Johnson acquired (NYSE:JNJ) Auris Health has lost a bid to move a patent infringement it faces from competitor Intuitive Surgical (NSDQ:ISRG) from Delaware to California. In the case, filed last August, Sunnyvale, Calif.-based Intuitive Surgical claims that Auris’ Monarch robotic surgical platform infringes on eight of Intuitive’s patents. Auris Health filed a motion looking […]
Enable Injections inks deal with Sanofi for drug delivery platform
Enable Injections said today that it inked a partnership with Sanofi for its enFuse drug delivery platform. Cincinnati-based Enable Injections developed the enFuse device to enable patient-administered subcutaneous delivery of high-volume therapeutics outside of the hospital. The on-body drug delivery platform has a self-contained drug transfer system that is compatible with standard syringes and vial […]
FDA panel recommends stiffer regulation of some surgical staplers
An FDA panel has recommended that surgical staplers for internal use be reclassified to a more highly regulated status. The General and Plastic Surgery Devices Panel met last week following a March alert the agency issued about internal-use surgical staplers. The devices have seen an uptick in concern over the past few months, with the FDA […]
Saluda Medical touts Evoke closed-loop SCS studies
Saluda Medical today released data from two studies of its Evoke ECAP-controlled closed-loop spinal cord stimulator. The Evoke SCS system is designed to measure the spinal cord’s response to stimulation and adjust on every pulse to maintain activation within the patient’s therapeutic window, the Australian company said. Results from both the Evoke and Avalon studies […]
AdvaMed head Whitaker lauds FDA, ignores recent device issues in NYT Op-ed response
AdvaMed prez & CEO Scott Whitaker shot back at a New York Times op-ed published earlier this month pushing for tighter FDA regulations, calling the federal watchdog “the gold standard the world over” while avoiding commenting on any of the issues raised in the original piece. Last week, the Times cited a number controversial devices […]
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