Beyond their altruistic and sales goals, medical device startups generally keep an eye out for the exit. Getting there requires planning, patience and persistence, according to a couple of medtech executives who’ve been through it. Martha Shadan headed Plymouth, Minn.–based Rotation Medical, a private company sold to Smith & Nephew in December 2017, just three […]
The FDA sent a warning letter earlier this month to Medtronic (NYSE:MDT) subsidiary Tyrx over problems with its process validation and quality systems. The Tyrx envelopes are designed to elute a pair of anti-microbial drugs, minocycline and rifampin, for 7 days before dissolving over a period of roughly 9 weeks. They’re cleared for use with pacemakers, implantable cardioverter-defibrillators, cardiac […]
Medtronic (NYSE:MDT) said today that it’s launching its Tyrx surgical envelope in the U.S. for use with deep-brain stimulation devices, after it won 510(k) clearance from the FDA for use of the infection-fighting envelope with implantable neurostimulators. Fridley, Minn.-based Medtronic said it’s planning to make the Tyrx device, acquired for $160 million in January 2014, available for […]
September 17, 2014 by Brad Perriello
TYRX won 510(k) clearance from the FDA to expand marketing indications for its AIGISRx N antibacterial envelope to include use with spinal cord neuromodulators.
The Monmouth Junction, N.J.-based company may now market the device as a tool to help reduce surgical site infections associated with implantable devices for both neurology and cardiology.
The FDA granted 510(k) to New Jersey-based TYRX for its next-generation AIGISRx R Antibacterial Envelope, indicated to address high infection rates after pacemaker and implantable cardioverter defibrillator implantation surgeries.
Second Sight Medical registered with the SEC for a $25 million offering of equity, debt, options and warrants as it waits for the FDA to decide whether to give the green light to its "bionic eye" retinal implant.
The Sylmar, Calif.-based medical device company filed with the securities watchdog agency yesterday, saying it has yet to sell any of the $1,000 shares in the offering.