Posts by cstephenson@legacymedsearch.com
Stryker Makes Takeover Approach to Boston Scientific
Boston Scientific shares rose nearly 7 percent Monday after the Wall Street Journal reported rival medical device manufacturer Stryker approached it with a takeover bid. A deal would combine two medical device giants into a powerhouse with a combined value of more than $110 billion, The Wall Street Journal reported, citing people familiar with the matter. Sources told…
Read MoreInsightec’s MR-Guided Focused Ultrasound Wins Medicare Coverage in 10 States
INSIGHTEC®, a global medical technology innovator of incisionless surgery, today announced that Medicare benefit coverage is available to patients in 10 U.S. states for MR-guided focused ultrasound (MRgFUS) for the treatment of essential tremor (ET). Six more states will follow on July 1, 2018. Additional Medicare Administrative Contractors (MAC) have issued positive Draft Local Coverage Determination…
Read MoreMIT Team Creates Wireless System to Power Implanted Devices
Researchers from the Massachusetts Institute of Technology (MIT) have collaborated with local Brigham and Women’s Hospital to create a new system that can wirelessly power and communicate with medical devices inside the body. The new In Vivo Networking (IVN) system employs radio frequency waves to power implanted devices. This is expected to eliminate the need…
Read More5 new deaths from liquid-filled intragastric balloons prompt FDA warning
The FDA today released a notice warning of five new patient deaths related to two liquid-filled intragastric balloon systems used to treat obesity, produced by Apollo Endosurgery (NSDQ:APEN) and ReShape Lifesciences (NSDQ:RSLS). The additional deaths bring the total number of deaths worldwide from the Orbera intragastric balloon and ReShape integrated dual balloon system up to 12 since 2016, the…
Read MoreMauna Kea Cellvizio Laser Receives Expanded Clearance for Neurological Procedures
Mauna Kea‘s (Paris, France) Cellvizio 100 series F400 and F800, with a new Confocal Miniprobe called CranioFle, has been granted FDA clearance to be used in neurological procedures targeting brain and spinal tumors. The confocal laser endomicroscopy system allows clinicians to analyze the cellular structure and characteristics of tissues right in the operating room. The…
Read MoreLayoffs at IBM Watson Health Spark Concerns
IBM has laid off approximately 50 to 70 percent of staff this week in its Watson Health division, according to inside sources. The axe, we’re told, is largely falling on IBMers within companies the IT goliath has taken over in the past few years to augment Watson‘s credentials in the health industry. These include medical data…
Read MoreFDA Approves First Artificial Iris
A German company has become the first to score FDA approval for a stand-alone prosthetic iris in the United States. The agency said Wednesday afternoon that it approved the CustomFlex Artificial Iris, made by Erlangen, Germany-based HumanOptics. The device, which is surgically implanted, is approved to treat adults and children whose iris is completely missing or damaged…
Read MoreTransEnterix Announces FDA Clearance for Expanded Indications for Senhance Surgical System
RESEARCH TRIANGLE PARK, N.C.–TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced that the Company has received FDA 510(k) clearance for expanded indications of its Senhance Surgical System. The Company received FDA 510(k) clearance for laparoscopic inguinal hernia…
Read MoreClass I Recall Issued by FDA for Abbott’s HeartMate 3 Heart Pump
The FDA issued a Class I recall for Abbott’s HeartMate 3 left ventricular assist device due to possible twisting of the outflow graft that could result in a persistent low-flow alarm, which normally signals potential safety risks including low blood flow or clotting that could lead to serious injury or death. The regulatory agency recommends that patients experiencing…
Read MoreFDA Permits Marketing of First Autonomous Artificial Intelligence-Based Medical Device
On April 11, 2018, the U.S. Food and Drug Administration (“FDA”) permitted marketing of the first device to use artificial intelligence (“AI”) autonomously to detect a medical condition. The device, called IDx-DR, utilizes an AI algorithm to screen for diabetic retinopathy. The device is unique in that its results do not require additional review by…
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