Each month, BIBA Briefings compiles a list of market approvals (European or US), FDA Device Designations, and recalls. For example, in December 2019, Cryolife received CE marks for two stent grafts (E-nya and E-nside), EOS imaging received 510(k) clearance from the FDA for its new generation imaging system (EOSedge), and Aleva Neurotherapeutics was awarded the CE mark for its directSTIM deep brain stimulation (DBS) system.
CE marks—E-nside & E-nya (Cryolife)
CryoLife has received two CE marks, with one for the E-nside thoracoabdominal aortic aneurysm stent graft and one for the E-nya thoracic stent graft system. Two press releases announcing the CE marks, respectively, report that E-nside is the company’s newest proprietary endovascular stent graft for patients with thoracoabdominal aortic disease and that the E-nya thoracic stent graft system is for the minimally invasive repair of lesions of the descending thoracic aorta (including thoracic aortic aneurysms and dissection).
CE mark—multivital medical wearable sensor and software development kit (VivaLink)
VivaLNK has received a Class IIa medical device CE mark for its multivital medical wearable sensor and software development kit (SDK). According to a press release, at only 7.5grams, the reusable patch is the smallest of its kind. The press release states that the patch’s reusability factor can increase the economic value of using the patch 10X or more compared to single use devices.
CE mark—directSTIM deep brain stimulation system
Aleva Neurotherapeutics has been awarded the CE mark for its—a press release reports—flagship product, the directSTIM deep brain stimulation (DBS) system. According to the press release, Aleva’s revolutionary DBS system incorporates directional electrode technology and is designed to be more precise and efficient, with optimised stimulation that will potentially reduce side effects. At present, Aleva is the only emerging technology company to be awarded the CE-mark for DBS.
FDA approval—PMA supplement B for i-FACTOR (Cerapedics)
The FDA has granted Cerapedics a premarket approval (PMA) supplement for its i-FACTOR peptide enhanced bone graft in anterior cervical discectomy and fusion (ACDF) procedures in patients with degenerative cervical disc disease. Cerapedics requested approval for an updated package insert that incorporates the 24-month follow-up data from patients enrolled in the original clinical study.
FDA approval—Bashir endovascular catheter—Short Basket (Thrombolex)
Thrombolex has received FDA clearance for its Bashir endovascular catheter—Short Basket (BEC S-B). The indication for use of the BEC S-B is for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. A press release reports that Thrombolex provides an innovative line of endovascular catheters, which feature a unique combination of mechanical-pharmaco, expandable infusion basket for effective treatment of venous thromboembolic conditions.
FDA 510(k) clearance—EOSedge (EOS imaging)
EOS imaging has received 510(k) clearance from the FDA for its new generation imaging system, EOSedge. Receipt of FDA 510(k) clearance follows the recent commercial launch of EOSedge in Europe, Canada and Australia. A press release reports that EOSedge is the first general X-ray system powered by a high-resolution photon counting detector, delivering optimal image quality for outstanding musculoskeletal imaging exams.
FDA 510(k) clearance—i:X handheld fluorescence imaging device (MolecuLight)
MolecuLight has received FDA 510(k) clearance for its i:X handheld fluorescence imaging device for use in the detection of wounds containing bacteria. This FDA 510(k) clearance is an expansion of the original de novo clearance for the MolecuLight i:X platform, which was granted 14 August 2018. A press release reports that the MolecuLight i:X enables real time point-of-care visualisation of fluorescence in wounds and measures wounds and digitally records all images and area measurements.