GI Dynamics (ASX:GID) said a retrospective study of its EndoBarrier device for patients with type 2 diabetes and obesity shows a significant reduction in HbA1c, weight, liver fat and cardiovascular disease (CVD) risks as well as a reduction in the need for insulin in some patients. The EndoBarrier device is a plastic gut sleeve designed to […]
FDA ramps up scrutiny of materials in medical devices
The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances. It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts […]
10 orthopedic products from AAOS 2019 you need to know
The American Academy of Orthopaedic Surgeons (AAOS) annual meeting in Las Vegas is abuzz about robotics, according to industry analysts from SVB Leerink. While the SVB Leerink analysts termed Stryker’s (NYSE:SYK) Mako platform “best-in-class,” it’s an expanding category. Other major orthopedics companies are using this week’s AAOS meeting to introduce new offerings or tout updates to existing […]
Miach Orthopaedics touts results of two-year study on ACL repair
Miach Orthopaedics said that a study of its bio-engineered implant for autograft anterior cruciate ligament (ACL) repair revealed results similar to those achieved by traditional ACL repair surgeries two years post-procedure. The non-randomized, two-arm study conducted at Boston Children’s Hospital enrolled 10 patients treated with Miach Orthopaedics’ bridging scaffold-enhanced ACL repair (BEAR) implant with hamstring autograft […]
Smith & Nephew acquires Brainlab assets, teases next-gen robotic surgical platform
Smith & Nephew (NYSE:SNN) said yesterday that it acquired Brainlab‘s orthopedic joint reconstruction business and teased the unveiling of a next-generation surgical robotics platform for later this year. The London-based company said that its acquisition of Brainlab’s orthopaedic joint reconstruction business included its associated salesforce, which it plans to fold into its surgical robotics division. It […]
Surgical staplers and staples linked to 41K+ injury or malfunction reports
FDA said today that it has received more than 41,000 adverse event reports — including 366 deaths — associated with surgical staplers and staples for internal use, and that it may require stricter product review of the devices. The agency’s ongoing analysis of stapler- and internal-staple-related adverse event reports from Jan. 1, 2011 to March […]
Cultivate(MD) buys into Embody and its ortho injury implant
Genesis Innovation Group‘s Cultivate(MD) Capital Fund II said that it has invested in Embody, a startup that has developed a collagen-based microfiber implant designed for use in Achilles’ and rotator cuff repairs. Embody (Norfolk, Va.) based its Tapestry implant on research on collagen-accelerating recellularization by growing new aligned tissue over surgical repairs. The company previously […]
FDA warns against robot-assisted breast cancer surgeries
FDA has issued a warning against the use of surgical robots in mastectomies and other surgeries for the treatment or prevention of cancer. The safety and effectiveness of surgical robots have not been established for use in mastectomies or for surgeries to prevent or treat breast and other cancers, according to the agency, which said […]
Vertos Medical’s spinal stenosis treatment wins CE mark
Vertos Medical said it has received CE mark approval for its lumbar spinal stenosis (LSS) treatment device kit. Aliso Viejo, Calif.-based Vertos said its Mild device kit enables a minimally invasive procedure to remove the cause of stenosis through a portal the size of a baby aspirin. The procedure requires no stitches, general anesthesia, implants or overnight hospital stays, […]
Apollo Endosurgery touts results of stomach-stapling study
Apollo Endosurgery (NSDQ:APEN) has reported key data from 1,000 patients who underwent endoscopic gastroplasty using the company’s OverStitch device. Published in the journal Gastrointestinal Endoscopy, the data include a mean total weight loss of 14.8%±8.5% at 18 months. Three months following surgery, the impact on obesity-related comorbidities included the complete remission of: 13 of 17 cases […]
Intuitive Surgical wins FDA clearance for robotic-assisted lung biopsy system
Intuitive Surgical (NSDQ:ISRG) said today that FDA has cleared its Ion system — a robotic-assisted, catheter-based platform meant to enable minimally invasive biopsy deep within the lung. Sunnyvale, Calif.–based Intuitive plans to start selling the Ion system in the U.S. in a measured fashion; it’ll start shipping to customers in coming months. The Ion system includes an […]
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