July 17, 2020 – Olympus (Center Valley, PA) has received FDA 510(k) clearance and announced the limited launch of HANAROSTENT Esophagus TTS self-expanding metal stents (SEMS) made by M.I. Tech and now distributed exclusively through Olympus in the U.S. The company says that the “Through The Scope” (TTS) esophageal stent helps to achieve luminal patency in a variety of … [Read more...]
Pfizer, Biontech granted FDA Fast Track designation for two investigational MRNA-based vaccine candidates for SARS-COV-2
Pfizer Inc. (New York, NY) and BioNTech SE announced that two of the companies’ four investigational vaccine candidates from their mRNA-based vaccine program being developed to help protect against SARS-CoV-2 (the virus that causes COVID-19), received Fast Track designation from the U.S. Food and Drug Administration (FDA). The two vaccine candidates are currently being … [Read more...]
Medtronic receives FDA clearance for LINQ II Insertable Cardiac Monitor (ICM)
Medtronic plc (Dublin, Ireland) announced it has received U.S. Food and Drug Administration (FDA) clearance and CE Mark approval for its LINQ II insertable cardiac monitor (ICM) with remote programming, which enables clinicians to optimize device settings without the need for patients to return to the office or hospital. LINQ II is a small (one-third the size of a AAA … [Read more...]
BD launches rapid point-of-care antigen test to detect COVID-19 in 15 minutes
BD (Becton, Dickinson and Company) (Franklin Lakes, NJ) announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for a rapid, point-of-care, SARS-CoV-2 diagnostic test for use with the company’s BD Veritor Plus System. This new assay delivers results in 15 minutes on an easy-to-use, highly portable instrument, which enables … [Read more...]
Abbott receives FDA approval for new heart rhythm devices featuring Bluetooth connectivity and continuous remote monitoring
Abbott (Abbott Park, IL) announced that the U.S. Food and Drug Administration (FDA) has approved the company's next-generation Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. The Bluetooth-enabled devices bring new benefits to patients with heart rhythm disorders, "including a patient-preferred design … [Read more...]
Olympus launches HookKnifeJ and TriangleTipKnifeJ
Olympus (Center Valley, PA) announced the U.S. market availability of two single-use electrosurgical knives for Endoscopic Submucosal Dissection (ESD). Olympus has introduced the 510(k) cleared HookKnifeJ for the esophagus, stomach and colon and the TriangleTipKnifeJ for the esophagus and stomach. The TriangleTipKnifeJ 510(k) clearance comes with a specific indication … [Read more...]
Masimo announces Bridge™
Masimo (Irvine, CA) announced Bridge™, an opioid withdrawal solution that uses neuromodulation to aid in the reduction of symptoms associated with opioid withdrawal. Bridge, which has been granted an FDA De Novo classification, is the first evidence-based, drug-free, non-surgical device of its kind. In clinical testing, Bridge was found to reduce opioid withdrawal symptoms … [Read more...]
FDA clears Boston Scientific insertable cardiac monitor system
The FDA has granted 510(k) clearance to LUX-Dx Insertable Cardiac Monitor (ICM) System developed by Boston Scientific. LUX-DxICM System is a long-term diagnostic device implanted in patients to detect arrhythmias related to conditions, including atrial fibrillation (AF), cryptogenic stroke and syncope. Patients are provided with a mobile device preloaded with the MyLUX app … [Read more...]
Masimo announces FDA clearance of Centroid
Masimo (Irvine, CA) received FDA clearance for Centroid, a wearable, wireless patient orientation, activity, and respiration rate sensor. According to the company, Centroid helps clinicians monitor patient position to avoid preventable pressure ulcers, and can alert clinicians to sudden movements such as fall-like events. The device also detects chest movements to continuously … [Read more...]
XPOVIO (selinexor), FDA approved for treatment of relapsed or refractory diffuse large B-cell Lymphoma (DLBCL), available at Biologics by McKesson
Biologics by McKesson, an independent specialty pharmacy specializing in oncology, rare diseases and other complex therapeutic areas, was selected by Karyopharm Therapeutics, Inc. as a specialty pharmacy provider for XPOVIO (selinexor) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (RR DLBCL), not otherwise specified, including … [Read more...]