1. BrainScope to develop pediatric traumatic brain injury assessment device
BrainScope announced in a Sept. 7 press release that it will immediately start creating a pediatric capability for its BrainScope One medical neurotechnology. The technology is an FDA-cleared handheld medical device that is designed to assess the full spectrum of traumatic brain injury. The company says that the pediatric version of its BrainScope One will be similar to the one that is currently available. The current device is easy-to-use and rapid and helps clinicians assess whether a patient has a structural brain injury that can be visible on a CT scan or if a patient has function brain impairment like a concussion.
2. BoneSupport inks French distribution deal
BoneSupport announced that it has signed a distribution deal with Novomedics, according to a Sept. 7 press release. The distribution deal intends to help BoneSupport gain access to the French market with its Cerament product line of bone void filler, Cerement G and Cerament V. The commercialization agreement allows for BoneSupport’s products to be sold in 8 key European markets while also directly marketing its products in five European countries in the U.K., Germany, Switzerland, Sweden and Denmark.
3. AliveCor touts Kardia study
AliveCor announced in a Sept. 6 press release the results of four clinical research presentations for its digital EKG, Kardia Mobile. Kardia is a hyperfast, 30-second digital EKG that uses artificial intelligence, mobile, cloud and microelectrode technology to help patients manage heart health. It helps patients and care teams easily, quickly and inexpensively detect and manage possible atrial fibrillation. The study found that people who used Kardia Mobile had a fourfold increase in atrial fibrillation detection. It also showed that the mobile device had an accuracy that was similar to what physicians can offer. It was able to detect more patients who had atrial fibrillation that had previously gone undiagnosed. The patients who participated in the study also reported that Kardia Mobile was easy to use.
4. Skyline Medical inks deal with Intalere for Streamway device
Skyline Medical has partnered with Intalere for Streamway System validation, according to a Sept. 5 press release. The contract states that Streamway will be incorporated into Intalere’s Innovation and New Technology category that will also indicate that Streamway demonstrates unique capabilities compared to other products on the market. The Streamway System was created by Skyline Medical and is FDA-approved for automated, direct-to-drain medical fluid disposal.
5. Delphinus launches SoftVue trial
Delphinus Medical Technologies announced in a Sept. 6 press release that it has launched its SoftVue Discover Breast Ultrasound Prospective Case Collection project and has enrolled the first patient. Those who are participating in the trial will undergo screening digital mammography and SoftVue 3D whole breast ultrasound exams. The information that is obtained from the study will compare SoftVue with digital mammography to determine how efficient SoftVue is with detecting additional cancers that can’t be seen with mammography, especially in women with dense breast tissue. The study plans to enroll 10,000 asymptomatic women who have dense breast tissue across the U.S.
6. C4 Imaging receives FDA nod for prostate cancer treatment
C4 Imaging has received FDA 510(k) clearance for its Sirius MRI Marker, according to a Sept. 5 press release. The device is designed to be a positive-signal MRI marker that is used during prostate cancer treatment with brachytherapy. The clearance allows for Sirius MRI Markers to be sterilized using ethylene oxide rather than gamma sterilization. Using ethylene oxide allows for increased convenience for customers and gives more benefits of MRI assisted brachytherapy to prostate cancer patients.
7. EOS Imaging launches spinal surgery planning software suite
EOS Imaging announced in a Sept. 5 press release that it has launched a new version of its spineEOS online 3D planning software for spinal surgery. SpineEOS uses biomechanics patient data for surgery simulation and helps physicians plan and optimize spinal treatment in patients. The planning software is based on EOS stereo radiographic 2D and 3D imaging.