Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. — ARROW INTERNATIONAL, LLC · Class I · Ongoing · 348,684
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices. — Abiomed, Inc. · Class I · Ongoing · 10,297 units
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. — ARROW INTERNATIONAL, LLC · Class I · Ongoing · 444,943
Firm observed oily and sticky substance on direct food contact surface packaging of finished product. — United States Bakery · Class II · Completed · 10,447 cases
Product requires refrigeration but the label is missing a "Keep Refrigerated" statement — Fairhope Roasting Company · Class II · Terminated · 15 gallons
At a time when energy security and affordability have risen to the top of the development agenda, 655 million people globally still lack access to electricity, and two billion use polluting fuels and technologies for cooking putting their health and well-being at risk.
Interim update to the guidance on the most effective methods of prevention and control of Clostridioides difficile infection. This guidance is currently under review.
As a federal court mulls a case that could result in significant restrictions on a pill used in most abortions, providers say they have alternatives to preserve access even in states with bans in place.
Massachusetts passed laws and joined lawsuits to protect access to gender-affirming care for minors. But faced with the Trump administration’s threats, some hospitals voluntarily stopped care. Families are outraged.
The biotech IPOs window is now open, but that doesn’t mean every company can go through it. A panel at the BIO Convention in San Diego discussed the steps biotech companies should take if they’re considering a public listing. The post The Things to Think About Before Taking Your Biotech Company Public appeared first on MedCity News .
Cadence raised $100 million in Series C funding to scale its AI-powered chronic care platform, which monitors patients at home and adjusts their medications in real time. The startup, now valued at $1.23 billion, partners with health systems to treat patients with heart failure, hypertension and diabetes. The post Cadence Rakes In $100M to Automate Chronic Care at Scale appeared first on MedCity News .