EchoNous announced that it has been granted FDA 510(k) clearance for its EchoNous Vein ultrasound device which could improve peripheral IV catheter placements. This system could provide real-time clear mages of superficial and deeper veins.
Kibbutz Shefayim from an Israel-based startup company named Zebra Medical Vision announced that it has successfully received FDA clearance for an algorithm, which could aid physicians to quantify a patient’s coronary artery calcification.
The FDA sent a warning letter to Sichuan Friendly Pharmaceutical after listing it in the import alert list due to its abysmal performance during a fall inspection. The FDA was not pleased with the manufacturing methods it saw at the Chinese API maker’s facility.
The premarket approval of Pulmonx’s Zephyr Endobronchial Valve to treat severe emphysema has green-lighted by the FDA. Zephyr is a pencil eraser-sized device delivered directly to the lung in a minimally invasive procedure. After the successful delivery, the device stops air from entering diseased parts of the lung during breathing. This mechanism prevents the air from getting trapped by damaged alveoli and stops the breathing difficulties.
Epidiolex, also known as purified cannabidiol was approved to treat Lennox-Gastaut syndrome and Dravet syndrome specifically in patients aged 2 and older. Both these conditions start during childhood. Recurrent seizures pose a huge risk of death.
The inject is developed to achieve the natural outflow of aqueous humor by making two patent bypasses through the trabecular meshwork, glaucomatous eyes the main source of resistance resulting in multi-directional flow through Schlemm’s canal
The U.S. healthcare system and the FDA have been affected by manufacturing issues at one of the largest U.S. drugmakers, Pfizer. The company’s Hospira unit is the largest producer of injectable opioid analgesics used in hospitals.
The Food and Drug Administration (FDA) has granted approval for a request made by DreaMed regarding their artificial intelligence-enabled diabetic software, which is exclusively meant for the providers, who are managing Type 1 diabetes patients.
Healthcare industry stakeholders say the FDA should consider a type of measuring stick when evaluating a vendor’s cybersecurity culture to decide whether it meets the requirements for the agency’s proposed fast-past program for premarket approval of "software as a medical device" products (SaMD). Until the end of the last month, the FDA accepted proposals on its working model for a SaMD pre-approval program
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