V-Wave said today that the FDA has granted breakthrough device designation for its interatrial shunt for heart failure (HF). The Caesarea, Israel-based company’s minimally invasive, implanted interatrial shunt is being evaluated in a global, randomized, controlled, double-blinded, 500-patient pivotal IDE trial called RELIEVE-HF. The study is enrolling advanced heart failure patients with preserved or reduced […]
Implants
Have government scientists solved the artificial hips corrosion problem?
Argonne National Laboratory researchers tested metal alloys that ortho device companies have used in artificial hips for decades. Materials scientists at the U.S. Department of Energy’s Argonne National Laboratory usually test metal alloys for their ability to contain nuclear waste for millions of years. A couple of years ago, two of them decided […]
Cardiovascular Systems acquires Gardia Medical’s embolic protection system
Cardiovascular Systems (NSDQ:CSII) yesterday announced that it acquired the Wirion Embolic Protection System and its related assets from Gardia Medical for $5.6 million. Cardiovascular Systems paid $5.6 million for the system and $1.5 million will be held in escrow until the 12 months following a successful manufacturing transfer. The company also issued Gardia 31,493 shares of […]
Alphatec raises nearly $58m
Alphatec (NSDQ:ATEC) said last week that it succeeded in raising $57.7 million in a stock offering for its line of spine implants. The Carlsbad, Calif.-based company had said it planned to float 10.9 million shares at $4.60 apiece, for gross proceeds of $50.1 million. That number rose to $57.7 million because the flotation’s underwriters fully […]
Ocular Therapeutix’s ophthalmic device gains Medicare coverage early
Ocular Therapeutix (NSDQ:OCUL) said today that the Centers for Medicare and Medicaid Services has assigned a specific and permanent reimbursement J-code for its Dextenza ophthalmic insert, which is approved for the treatment of ocular inflammation and pain following ophthalmic surgery. The code assigned to Dextenza through the Healthcare Common Procedure Coding System will become effective on […]
Med-El USA lands first FDA approval for single-sided deafness implant
Med-El USA said today that the FDA has approved its cochlear implant for single-sided deafness and asymmetric hearing loss, a first for these indications in the U.S., according to the Durham, N.C.-based company. Med-El’s cochlear implant systems, including Synchrony and the recently FDA-approved Synchrony 2, are now indicated for individuals aged 5 years and older […]
Spinal startups Carlsmed and Precisive Surgical merge
Startup spinal implant company Carlsmed and startup spine imaging system company Precisive Surgical have completed a merger to develop a personalized surgical workflow platform. The system will combine clinical intelligence, advanced image recognition, and 3D printing to enable earlier surgical intervention delivering personalized implants to patients with complex, multi-level spinal alignment deviation, according to San Diego-based Carlsmed. The system […]
The 17 most innovative medical devices of 2019
The Galien Foundation recently announced nominees for most innovative medical devices for its 13th Annual Prix Galien USA Awards. The foundation awards the Prix Galien Award annually to examples of outstanding biomedical and technology product achievements that are designed to improve human condition. Nominees need to be FDA approved for market within the last five […]
Osseus Fusion Systems acquires SIJ Surgical
Implantable spine products maker Osseus Fusion Systems (Dallas, Texas) said it has acquired SIJ Surgical. SIJ Surgical’s SI screw system has distal cutting flutes, dual lead threads, and fenestrated, open implant architecture designed to improve osseointegration and reduce radiographic signature, according to Osseus. Get the full story on our sister site, Medical Design & Outsourcing.
FDA warns of magnetic interference involving hearing devices
The magnets in some hearing implants may interfere with the operation of programmable cerebrospinal fluid (CSF) shunt systems used to treat hydrocephalus, causing over- or under-drainage, the FDA warned yesterday. Magnetic interactions between cochlear implants, bone-conduction hearing devices or middle-ear hearing devices implanted too closely to shunt systems may “ lead to unintended changes to […]
Australia eyes ban on textured breast implants
Australia’s TGA said last week that it concluded breast implants do not need to be removed as breast implant-associated anapestic large cell lymphoma (BIA-ALCL) is rare. The regulatory body said in April that is was considering implementing a ban on textured breast implants and was seeking new data from suppliers of the implants to decide […]