7 medtech stories we missed this week: Oct. 27, 2017

October 27, 2017 By Danielle Kirsh

[Image from unsplash.com]

From RadiaDyne’s FDA expansion to NuVasive launching its new implants, here are seven medtech stories we missed this week but thought were still worth mentioning.

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.

Here’s what we missed last week.

Switchback Medical adds ‘sandbox approach’ to device testing
Contract manufacturer Switchback Medical (Maple Grove, Minn.) today announced that it has added a new division. Switchback BioSim Innovations offers functional dynamic biosimulator model development, cell culture services and physician training, according to the company. Biosimulator models use animal and human tissue to create functional models, such as a pumping heart with working valves to… […]
Smith College team wins ventilator design challenge
A team of Smith College engineering alumnae, staff and faculty has won the CoVent-19 Challenge to design a rapidly deployable ventilator to address shortages caused by the COVID-19 pandemic, particularly in developing countries. A dozen anesthesiology resident physicians from Massachusetts General Hospital kicked off the public challenge April 1, attracting 200 entries. The 30-person team… […]
FDA gives certain device makers more time to add UDIs
The FDA said today that it will grant manufacturers of Class 1 and unclassified medical devices and certain others more time to add unique device identifiers (UDIs) to their products. These companies will now have until Sept. 24, 2022 to comply with the agency’s UDI rule, including standard date formatting, labeling and Global Unique Device… […]
Eurofins launches 10-minute COVID-19 exposure testing device
Eurofins (Paris:ERF.PA) announced today that it launched its rapid point-of-care testing devices to identify past exposure to COVID-19. The serology-based, finger-prick tests detect antibodies with a sensitivity of 94.5% from 19 days following the onset of symptoms, with results coming in just 10 minutes, according to a news release. Get the full story at our sister site,… […]
How is RF technology shaping the future of medtech?
RF technology, including microwaves, isn’t just about wireless communications or military radar these days. Times Microwave Systems experts point out that it is increasingly important when it comes to medtech. Many medical electronics systems such as magnetic resonance imaging (MRI) systems for cancer detection rely on RF/microwave technology. Times Microwave Systems (Wallingford, Conn.) is hosting… […]
Medical device litigation and COVID-19: What you need to know
The COVID-19 pandemic is creating a new set of medical device litigation challenges — but also a chance for an industry reset. One of Greenberg Traurig’s top medtech litigation lawyers shares her insights. Sara Thompson doesn’t take any guff when she tells people that she defends medical device and pharmaceutical companies from lawsuits. “I say,… […]
Mayo Clinic needed to engineer its way through COVID-19: Here’s what they did.
The health system’s medical and engineering staffs had to devise their own solutions for lab gear, PPE and operating room air decontamination. As COVID-19 settles into several regions of the U.S., healthcare systems that once sat on the sidelines likely will find themselves in the same situation as their counterparts in the Northeast did earlier… […]
Xenco Medical launches porous spinal implant
Xenco Medical this week said it launched its Cancellex porous titanium lumbar interbodies. The injection-molded titanium foam spinal implants are designed to be pre-attached to disposable, composite polymer instruments. They feature interconnected porosity throughout each implant and are designed to promote bone apposition and facilitate vascularization Each implant is sterile packaged and comes pre-attached to… […]
Applied Plastics adds VP of sales
Applied Plastics (Norwood, Mass.) — maker of PTFE-coated products for advanced catheter systems — announced today that Michael Brown has joined the company as VP of sales and marketing. Brown will be responsible for global sales and marketing, including Applied Plastics’ new online store, which offers shipment within the U.S. and Europe. The company recently… […]
Heraeus Medical Components opens new Collaboration Hub outside Minneapolis
Heraeus Medical Components recently announced that it has opened a new nearly 67,000-square-foot Collaboration Hub in the Minneapolis-St. Paul medtech cluster. The Collaboration Hub — a completely new location near the Heraeus’ existing Fridley, Minn. facility — is meant to provide the company’s customers with the opportunity to work on-site with Heraeus Medical component R&D… […]
Pantheon Surgical acquires sacroiliac screw system
Pantheon Surgical recently announced its acquisition of the Topaz/Compressive sacroiliac screw system. Pantheon Surgical acquired the technology from Osseus Fusion Systems, which will continue to distribute the Blue Topaz/Compressive system. Financial terms of the deal were undisclosed. “I’m excited about the transfer acquisition of the Blue Topaz/Compressive system into the Pantheon armamentarium. I look forward… […]