Surgical Information Sciences (SIS), a medical device company focused on improved targeting for deep brain stimulation (DBS) surgery, announced it recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market new visualization capabilities.
VivaQuant, a digital health company with powerful technology to accurately and efficiently identify and report cardiac arrhythmias, has received FDA clearance for its RX-1 wearable device.
Provides Priority Regulatory Review of AI-Enabled Diagnostic for Fast-Progressing Kidney Disease
The FDA will have a hearing on scientific data and information about products containing cannabis or cannabis-derived compounds on May 31 from 8 a.m. to 6 p.m.
The Regulatory Education for Industry Annual Conference will be held May 29-30 at the Revere Hotel, 200 Stuart St., Boston.
A bill proposing the right to try adult stem cell treatments was introduced in the North Carolina House on April 22.
Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the U.S. Food and Drug Administration (FDA) for MagicTouch, its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of coronary in-stent restenosis (ISR).
Hi-Tech Pharmaceuticals sued the FDA May 2nd, 2019 in Federal Court- Case 1:19-cv-01268, claiming the agency bypassed standard rule-making procedures in favor of a campaign of intimidation to try to force companies to destroy their products containing 2-Aminoisopheptane, or DMHA.
The Food and Drug Administration this week updated its list of which drugs are in short supply in the nation and which previous drug shortages have been resolved.
LENSAR® Laser System with Streamline® IV Capabilities Expands to Include Micro Radial Incisions, Allowing Surgeons to Treat Additional Corneal Conditions
Abiomed (NASDAQ: ABMD) announces that, on April 26, the FDA approved initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial.
OnKure, Inc., the epigenetics-focused drug discovery and development company that is advancing the first Largazole-derived, histone deacetylase inhibitor into Phase 1 clinical trials, announced that its lead drug, OKI-179, has cleared the FDA IND regulatory hurdle to start Phase 1 trials.
Legislation that would allow terminally ill patients to access stem cell treatments not yet signed off by the U.S. Food and Drug Administration now is in the North Carolina state Senate after unanimously passing the House last week.
Vizient, Inc. today submitted comments to the Food and Drug Administration (FDA) in response to its published draft guidance on the nonproprietary naming of biological products.
Whistleblowers are claiming that pharmaceutical companies are bribing doctors to sell their drugs so they can raise the prices on them.
Statement from Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on policies designed to capture more data to better understand effects of prescription drugs in pregnant and nursing women
The first generic version of Penicillamine Capsules USP is now approved in the U.S.
Regis Technologies, a contract development and manufacturing organization for small molecule active pharmaceutical ingredients, earned perfect results from its April 2019 FDA inspection.
