Becton Dickinson & Co. (NYSE:BDX) said today that the FDA granted pre-market approval for its Venovo stent for treating iliofemoral venous occlusive disease. Franklin Lakes, N.J.-based BD touted Venovo as the first on the U.S. market approved to treat obstructed blood flow in the iliac and femoral veins. “The FDA pre-market approval of the Venovo venous […]
Featured
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 […]
Medtronic’s Covidien to pay $20m to settle ClosureFast kickback allegations
Medtronic‘s (NYSE:MDT) Covidien has agreed to pay approximately $20 million to resolve kickback allegations related to the sale and promotion of its ClosureFast radiofrequency ablation catheters. The Fridley, Minn.-based company agreed to pay approximately $17.5 million to the U.S. to settle alleged violations of the False Claims Act and an additional $1.5 million to California […]
FDA issues ‘leap-frog’ guidance on brain/computer interfaces
FDA has issued draft guidance for developers of devices to help amputees and people with paralysis regain mobility or their sense of touch. FDA defines brain/computer interface (BCI) devices as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities. The guidance proposes that non-clinical device testing can be used […]
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 […]
Boston Scientific wins CE Mark for Watchman FLX anti-stroke implant
Boston Scientific (NYSE:BSX) said today that it won CE Mark approval in the European Union for the next iteration of its Watchman anti-stroke heart implant. The Marlborough, Mass.-based medical device maker said the Watchman FLX is designed to be easier to implant during procedures to occlude the left atrial appendage and is re-capturable and re-positionable intraprocedurally. […]
Think Surgical raises $134m for TSolution One robotic joint replacement device
Think Surgical yesterday reported a funding round worth $134 million for the robot-assisted orthopedic surgery device it makes. The Fremont, Calif.-based company’s TSolution One is designed for knee and hip arthroplasties. It’s approved in the U.S. and Europe for total hip procedures; in December 2017 the company won CE Mark approval for a total knee […]
Medacta IPO on track for Q2
Swiss medical device maker Medacta Group is reportedly on track for an initial public offering during the second quarter. The company would issue a limited amount of shares into public trading, maintaining the founding Siccardi family’s control intact, according to Reuters. The IPO would also include an over-allotment option, the newswire reported. Rumors of the […]
NCI head Sharpless tapped to lead FDA
National Cancer Institute head Dr. Norman Sharpless will serve as acting commissioner of the FDA, according to a statement from HHS Secretary Alex Azar. Though he has yet to be formally nominated, the move will likely position Sharpless as an official successor to Dr. Scott Gottlieb, who is slated to depart in April. “Ned is […]
Exactech acquires XpandOrtho
Exactech (NSDQ:EXAC) said today that it acquired knee replacement surgery instrument maker XpandOrtho for an undisclosed amount. Gainesville, Fla.-based Exactech said that it plans to incorporate XpandOrtho’s soft tissue balancing technology into its ExactechGPS computer-assisted surgery system designed to support shoulder and knee replacements. “This allows our technology, which has been in development for more than […]
Neovasc advances warrant exchange from CardiAQ case
Neovasc (NSDQ:NVCN) said today that it inked an exchange deal for the last of the warrants it issued as part of a $65 million funding round to cover the damages from litigation with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve. The Vancouver-based replacement heart valve developer said it plans to exchange the Series A and Series E warrants it […]