1. FDA expands indications for RadiaDyne’s OARtrac dose monitor
RadiaDyne announced in an Oct. 24 press release that it has received additional FDA clearance for its upcoming OARtrac. The OARtrac allows physicians to routinely monitor brachytherapy radiation dose as well as being able to reuse the OARtrac Plastic Scintillating Detector sensor cable no more than five times on one patient.
2. FDA clears Ortek’s electronic cavity detection system
Orktek Therapeutics has received FDA 510(k) clearance for its Ortek ECD, according to an Oct. 24 press release. The ECD is a lightweight tabletop device that is used as an aid for dental professionals to diagnose and monitor dental cavities in molar and premolars. The system has been shown to detect the earliest forms of mineral loss in enamel before a cavity was able to form.
3. Michael J. Fox Foundation, Tau Consortium partner to develop imaging tools for neurodegenerative diseases
The Michael J. Fox Foundation and Tau Consortium announced their new partnership in an Oct. 24 press release. The partnership is designed to accelerate the development of positron emission tomography (PET) imaging tracers to detect alpha-synuclein and tau proteins in the brain. Detection of these proteins will help improve clinical care and speed up drug development for neurodegenerative diseases like Parkinson’s disease, Lewy body dementia, multiple system atrophy and more.
4. Varian launches HyperArc in U.S.
Varian announced in an Oct. 24 press release that it has launched its HyperArc High Definition Radiotherapy (HDRT) by treating its first five patients with the device. HyperArc is a new type of radiosurgery, according to the company, that is designed to automate and simplify treatments like stereotactic radiosurgery (SRS) while making it more available to more people around the globe.
5. Alcyone gets CE Mark for Alivio ventricular cath
Alcyone Lifesciences has received CE Mark approval for its Alivio Ventricular Catheter and Flusher System that is designed to treat Hydrocephalus, according to an Oct. 24 press release. The system combats common cerebrospinal fluid shunt problems like ventricular catheter obstructions.
6. Implanet receives CE Mark for Jazz Passer spine implant
Implanet announced in an Oct. 19 press release that it has received CE Mark in Europe to market its new Jazz Passer, which also recently received FDA 510(k) clearance. The European clearance allows the company to offer its technology in Europe’s estimated $800M spinal surgery market.
7. NuVasive launches Modus titanium implant
NuVasive has launched its newest 3D printed porous titanium implant, according to an October 18 press release. The Modulus XLIF titanium implants are designed to support lateral spine procedures. The 3D printing that is used to create the implants helps make an organic, porous architecture that is similar to the porosity and stiffness of bones for reduced stress shielding.