Search Results for “FDA” – Page 58 – media

FDA Warns of Unapproved Vaginal ‘Rejuvenation’ Procedures

The US-FDA has warned against medical device manufacturers for developing cosmetic vaginal rejuvenation procedures to treat vaginal atrophy, laxity, itching/dryness, pain during sex or urination and reduced sexual sensation.
- Source: Medpagetoday
- 845
- August 1, 2018
FDA Policies
Endomag Breast Cancer Device Gains FDA Approval

Endomag received premarket approval from the FDA for Magtrace, the novel non-radioactive dual-tracer for lymphatic plotting in breast cancer patients which facilitates the implementation of magnetic detection during sentinel lymph node biopsy procedures to spot sentinel lymph nodes for surgical excision.
- Source: The Verdict
- 780
- August 1, 2018
cancer FDA medical device New Approvals
NuVasive gets FDA Approval for Pulse Spinal Surgical Automation Platform

The San Diego-based company NuVasive has announced US-FDA 510(k) clearance for its Pulse spinal surgical automation platform. The platform includes 2D and 3D navigation and smart imaging capabilities, with implemented surgical planning, neuromonitoring, patient-specific rod bending tech and radiation reduction.
- Source: MassDevice
- 188
- July 31, 2018
FDA medical device New Approvals
Contamination of Synthetic Cannabis with Rat Poison Affects Blood Supply

Various synthetic cannabis products such as “spice” and K2 have been contaminated with a rat poison ingredient that affects the blood supply. Hundreds of people in 10 states in the USA have been diagnosed with symptoms like seizures and severe bleeding after using these products, as declared by US-FDA.
- Source: NBC News
- 844
- July 30, 2018
FDA Policies
FDA Approves Healthy.io Smartphone Camera-based Home Urine Analysis

Healthy.io, of Israel, gains FDA 510(k) approval for Dip.io, it's domestic urinalysis kit that transforms a smartphone into a clinical-standard diagnostic machine. It is the first and only smartphone-based urine analysis to be cleared as a Class 2 device.
- Source: MobiHealthNews
- 586
- July 27, 2018
FDA mHealth New Approvals
Siemens gets FDA Clearance for Troponin Assay

Siemens Health received US-FDA (US-Food and Drug Administration) clearance for two highly sensitive troponin assays, which detect protein levels released into the bloodstream during a heart attack allowing them to be made available in the U.S.
- Source: FierceBiotech
- 1,021
- July 27, 2018
blood test heart attacks New Approvals troponin assay
Valsartan Based Drugs Recalled by FDA

At the beginning of this month, the U.S. Food and Drug Administration (FDA) announced to withdraw drugs containing valsartan, which treat high blood pressure and heart failure. The drugs were withdrawn due to the presence of N-nitrosodimethylamine (NDMA), which might lead to cancer.
- Source: HealthLine
- 865
- July 26, 2018
blood pressure cancer FDA heart failure Policies
Mersana’s Lead Cancer ADC Held Up by FDA for Patient’s Death

The FDA held up Mersana’s top antibody-drug conjugate (ADC), XMT-1522 over safety issues following a patient’s death in phase 1 trial, causing a descent in the company’s shares.
- Source: FierceBiotech
- 196
- July 25, 2018
cancer Clinical Trial FDA
Karyopharm Seeks FDA Approval for Selinexor Drug for Multiple Myeloma

The Newton Massachusetts-based company, Karyopharm Therapeutics, who developed a new class of drugs to treat multiple myeloma, is in the process of submitting a new drug application to the FDA for their selinexor drug.
- Source: MedCityNews
- 410
- July 24, 2018
cancer CAR-T therapies FDA 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
- 725
- July 17, 2018
FDA New Approvals smallpox

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.