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FDA greenlights Boston Scientific’s Novel Drug-Coated Balloon for Coronary In-Stent Restenosis
Boston Scientific’s AGENT™ Drug-Coated Balloon (DCB) has been granted approval by the U.S. Food and Drug Administration (FDA) for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. While advancements in percutaneous coronary intervention (PCI) technologies are ongoing, recent research indicates that ISR, the gradual re-narrowing of a previously opened coronary artery, still…
Read MoreSparrow BioAcoustics Launches Software That Turns a Smartphone into a Stethoscope
Sparrow BioAcoustics recently unveiled its StethophoneTM software, which transforms smartphones into medical-grade stethoscopes. This innovative tool enables users to capture, analyze, and share crucial heart health data with medical professionals from any location. In June 2023, Sparrow received FDA clearance for the downloadable application, making it the first FDA-cleared smartphone stethoscope software-as-a-medical-device (SaMD). The company…
Read MoreDermaSensor Unveils Study Results Demonstrating Ability to Detect Skin Cancer With Device Granted FDA Breakthrough Designation
DermaSensor Inc., a health technology company equipping primary care physicians (PCPs) with a non-invasive device for use in evaluation of suspicious skin lesions, presented a pooled analysis today from two clinical studies evaluating the performance of the company’s device in detecting skin cancer. In the DERM-ASSESS III and DERM-SUCCESS clinical studies, the device had a…
Read MoreSonorous NV Uses New Device to Treat Patients with Symptomatic Cerebral Venous Diseases
Sonorous NV, Inc. Chairman, Dave Ferrera, announced treatment of the first patients in North America with the BossStent® device designed to treat patients with symptomatic cerebral venous diseases. The single-use, implantable device acts as an endoluminal prothesis that is placed into a cerebral venous sinus stenosis to normalize blood flow and pressure gradients causing pulsatile tinnitus and/or IIH (idiopathic intracranial hypertension),…
Read MoreWhat Are You Thankful For? | Legacy MEDSearch 2022
The holiday season always brings a time of family, friends, good food, and also reflection on the year. This year as we are in the season of giving thanks, we asked our team what everyone was thankful for this holiday season. Here is what they had to say! “I’m thankful for my family; my wife…
Read MoreOlympus Introduces New Version of Troubled Gynecological Device
Can a gynecological surgical device with a bad reputation make a comeback? Olympus America Inc. hopes so. The company on Tuesday launched its new tissue-fragmenting device, called an electric morcellator, with a novel attachment: a containment bag intended to keep the machine from accidentally spreading uterine cancer. Electric morcellators, introduced in 1993, enable doctors to…
Read More3D Print-On-Demand Bone Could Quickly Mend Major Injuries
If you shatter a bone in the future, a 3D printer and some special ink could be your best medicine. Researchers have created what they call “hyperelastic bone” that can be manufactured on demand and works almost as well as the real thing, at least in monkeys and rats. Though not ready to be implanted…
Read MoreOsiris Therapeutics Adds TruSkin™ to it’s Wound Care Portfolio
COLUMBIA, Md.–(BUSINESS WIRE)–Osiris Therapeutics, Inc. (NASDAQ:OSIR), the leading cellular regenerative medicine company focused on developing and marketing products to treat conditions in wound care, orthopaedics and sports medicine, announced today the launch of TruSkin™, a cryopreserved, living skin allograft. TruSkin has been developed to provide healthcare professionals a new option for treating large, chronic wounds…
Read MoreSoftware Companies Jump Through Hoops for FDA Classification
Broadly defined, software as a medical device is any application used by providers to make clinical decisions. An increasing number of applications are now officially designated as FDA-regulated devices. Is it worth it to pursue this classification for your own software? If your objective is to make it an indispensable tool in the healthcare and…
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