VisionQuest Biomedical Inc. (VisionQuest) announced today that the company has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market the Image Quality Analyzer (IQA) software, which reduces unreadable images captured in teleretinal screening programs by retinal photographers.
Sustained acoustic medicine (SAM) technology, approved by the FDA in 2013 for clinical utilization, sees re-approval for expanded indications in 2020.
DRIVEWIRE™ provides efficient access in difficult neuro and peripheral vascular procedures
Agency authorized first device indicated to treat patients with necrotic tissue resulting from complications of acute pancreatitis
Kennedy: Company Excited to Expand Generic Portfolio to Include Non-Respiratory Products
The U.S. Food and Drug Administration approved Tagrisso (osimertinib) as the first adjuvant treatment for patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation.
Slayback Pharma LLC issued the following announcement on Dec. 18.Slayback Pharma LLC announced today that it has received final approval for its Abbreviated New Drug Application (ANDA) for Merzee (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1 mg/20 mcg from the USFDA with a Competitive Generic Therapy Designation.
The U.S. Food and Drug Administration approved the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System
The U.S. Food and Drug Administration approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer.
Oral XPOVIO Now Available as a Treatment Option for Patients with Multiple Myeloma As Early as First Relapse; Significantly Expands Addressable Patient Population
Large, Randomized Controlled ADVENT Trial Designed to Establish New Gold Standard for AF Ablation
Volta Medical, a pioneering French-based HealthTech startup is pleased to announce that it has obtained FDA clearance for its revolutionary VX1 AI (artificial intelligence) software.
The COVID-19 pandemic has resulted in an immense number of deaths, disrupted economies worldwide and is a public health emergency.
Guerbet (GBT), a global leader in medical imaging, announced today that it received US Food and Drug Administration approval for the commercial sale of the Optiray® Imaging Bulk Package (IBP) in the United States, as well as FDA clearance of the LF IBP Transfer Set.
CorticoMetrics announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for THINQ™, its AI-based software for use by radiologists and neurologists providing quantitative information to augment patient assessment for a number of neurological disorders and conditions.
Radiologists can now securely collaborate in realtime from anywhere
AliveCor Paving the Way For A New Generation of AI-Powered Remote Cardiology