FDA – Page 4 – media

FDA Clearance for Algorithm that Quantifies Coronary Artery Calcification

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.
- Source: MobiHealthNews
- 724
- July 13, 2018
coronary arteries FDA New Approvals
FDA Rebukes Chinese API maker Sichuan Friendly Pharmaceutical in Warning Letter

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.
- Source: FiercePharma
- 739
- July 9, 2018
FDA pharmaceutical company Policies
FDA Approves Pulmonx’s Zephyr Device to Treat Emphysema

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.
- Source: FierceBiotech
- 884
- July 4, 2018
emphysema FDA medtech New Approvals
FDA Approval for Cannabis Based Epidiolex Medicine Against Seizures

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.
- Source: FiercePharma
- 566
- June 27, 2018
FDA Medical marijuana New Approvals
Glaukos Corporation to receive Pre-Market approval for Next-Gen iStent

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
- Source: BioSpectrumAsia
- 552
- June 26, 2018
FDA medtech New Approvals Optometry
Shortage in Drug Supplies, According to FDA

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.
- Source: FiercePharma
- 793
- June 22, 2018
FDA Market Views Pfizer
FDA Approval for AI Enabled Diabetes Software

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.
- Source: MobiHealthNews
- 856
- June 20, 2018
AI digital health FDA New Approvals type 1 diabetes
FDA Gives OK for mHealth Wearable to Combat Opioid Addiction

DyAnsys’ Drug Relief, a wearable that is worn around the patient’s ear, is a neurostimulation therapy that helps to relieve the symptoms of opioid withdrawal such as depression, anxiety and cravings.
- Source: mHealth Intelligence
- 757
- June 15, 2018
FDA mHealth New Approvals opioid
FDA Considering Comments on SaMD Precertification Program

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
- Source: Healthcare Info Security
- 729
- June 14, 2018
digital health FDA Market Views medical device
FDA Seeks Help From Social Media Giants To Help Stop Illegal Opioid Distribution

Scott Gottlieb, FDA Commissioner is looking for help from Facebook and Twitter to slow down the unauthorized opioid sales in the US. Gottlieb invited the two social media giants, among others, to participate in the FDA Online Opioid Summit which is set for June 27.
- Source: Fierce Pharma
- 572
- June 11, 2018
Company Insight digital health FDA opioid

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