New Approvals – Page 4 – media

Electrocore Releases Gammacore Therapy against Migraine and Episodic Cluster Headaches

ElectroCore, famous for bioelectronic medicines, is associating with UpScriptHealth to deliver its gammaCore treatment via direct-to-patient telemedicine program. This non-invasive stimulation therapy of vagus nerve is used to treat migraines and episodic cluster headaches among the adults.
- Source: FierceBiotech
- 777
- July 19, 2018
biotech cluster headache medtech migraine New Approvals
Siga Technologies Wins FDA Approval for Tecovirimat to Treat Smallpox

A New York-based company named Siga Technologies has won FDA approval for its oral formulation of tecovirimat, used to treat smallpox, in case there occurs an outbreak.
- Source: DrugDeliveryBusiness
- 738
- July 17, 2018
FDA New Approvals smallpox
FDA backs GSK’s Tafenoquine for Malaria Cure

Sanction of a single 300mg dose of GlaxoSmithKline’s tafenoquine in patients 16 years and above for the "radical cure" of malaria was advocated by an FDA advisory committee on finding significant evidence for its efficacy and safety.
- Source: MedPageToday
- 4,429
- July 16, 2018
FDA GSK malaria New Approvals
FDA Clearance for Echonous Vein Ultrasound

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.
- Source: The Verge
- 5,614
- July 16, 2018
FDA medical device New Approvals ultrasound
FDA Clears First Autonomous AI Diagnostic System Rolled out by University of Iowa Healthcare

The U.S. Food and Drug Administration approved the first autonomous artificial intelligence diagnostic system, IDx-DR and the University of Iowa Healthcare has become the first healthcare organization to implement it.
- Source: HealthcareIT News
- 955
- July 15, 2018
AI digital health New Approvals
Bristol-Myers Squibb’s Combo Drug gets FDA Approval

Bristol-Myers Squibb’s recent immunotherapy combo won FDA approval for patients with a rare colon cancer. The combinational medicine was formulated between an older medicine named Yervoy and a new cancer-fighter Opdivo. This combo drug focuses on repairing the mismatch gene.
- Source: FiercePharma
- 4,415
- July 13, 2018
Bristol-Myers Squibb cancer colorectal cancer New Approvals
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
- 736
- July 13, 2018
coronary arteries FDA New Approvals
Onitor Track – A Weight Loss Wearable

Onitor Track is an advanced biometric, data-driven program which aids in weight loss. Onitor Track combines a personalized weight loss and nutrition program with a dual-positioned wearable via an app.
- Source: mHealthSpot
- 2,028
- July 6, 2018
mHealth New Approvals weight loss
NHS App Invention to Book GP Appointments

NHS Digital and NHS England together have devised a free NHS app to book GP appointments in a swifter and user-friendly way. This novel NHS app will be launched in December 2018, allowing patients to access their health records in a safe and secure manner.
- Source: The Verge
- 890
- July 6, 2018
mHealth New Approvals NHS
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
- 895
- July 4, 2018
emphysema FDA medtech New Approvals

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