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Popular Posts

Report: SEC probes GE Healthcare, Philips, Siemens in Chinese bribery scheme

June 4, 2019 By Brad Perriello

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, […]

Filed Under: Featured, Legal News Tagged With: GE Healthcare, General Electric, Philips, Popular Posts, Siemens

Edwards Lifesciences warns against below-market mini-tender offer

June 4, 2019 By Fink Densford

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 […]

Filed Under: Business/Financial News, Featured, Wall Street Beat Tagged With: Edwards Lifesciences, Popular Posts

J&J’s Ethicon files ITC complaint against Intuitive Surgical

June 4, 2019 By Brad Perriello

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 […]

Filed Under: Featured, Robotics, Surgical, Wall Street Beat Tagged With: Ethicon, Intuitive Surgical, Johnson and Johnson, Popular Posts

Auris Health loses motion to move Intuitive Surgical patent suit from Del. to Cali.

June 3, 2019 By Fink Densford

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 […]

Filed Under: Featured, Legal News, Patent Infringement, Robotics Tagged With: aurishealth, Intuitive Surgical, Johnson and Johnson, Popular Posts

Enable Injections inks deal with Sanofi for drug delivery platform

June 3, 2019 By Danielle Kirsh

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 […]

Filed Under: Drug-Device Combinations, Featured Tagged With: Enable Injections, Popular Posts, Sanofi

FDA panel recommends stiffer regulation of some surgical staplers

June 3, 2019 By Nancy Crotti

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), News Well, Surgical Tagged With: FDA, FDA advisory panels, Popular Posts

Saluda Medical touts Evoke closed-loop SCS studies

June 3, 2019 By Fink Densford

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 […]

Filed Under: Clinical Trials, Featured, Pain Management, Spine Tagged With: Popular Posts, saludamedical

AdvaMed head Whitaker lauds FDA, ignores recent device issues in NYT Op-ed response

May 13, 2019 By Fink Densford

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 […]

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: AdvaMed, Popular Posts

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