Search Results for “FDA” – Page 13 – media

【EXPERT Q&A】What is the relationship between FDA registration and 510K registration for medical devices and what is the difference?

Drugdu.com expert’s response: The relationship between FDA registration and 510(k) clearance for medical devices involves overlap but also key distinctions. Relationship: 1.FDA Registration: This encompasses the process of submitting product information to the U.S. Food and Drug Administration (FDA) and obtaining FDA approval. It includes various types of registrations, such as 510(k) clearance, Premarket Approval (PMA), among others. 2.510(k) Clearance: This is a specific certification process within FDA’s regulatory framework, typically applicable to certain medical devices for which there are similar existing products on the market. In the 510(k) clearance process, manufacturers need to demonstrate that their product is substantially equivalent to an existing marketed device and does not pose an unreasonable risk to the user. Differences: 1.FDA registration is a broader concept encompassing various registration pathways, of which 510(k) clearance is one. 2.Within FDA registration, if a medical device can demonstrate substantial equivalence to a predicate device and meets ...
- Source: drugdu
- 173
- April 30, 2024
Exo adds FDA-cleared AI tools to handheld ultrasound system

Dive Brief Exo has made new artificial intelligence tools available on its Iris handheld ultrasound system, the company said Tuesday. The Food and Drug Administration cleared Exo’s AI tools for analyzing ultrasound images of the heart and lung last year. Exo sees the new capabilities as particularly beneficial for health systems and caregivers in rural and under-resourced settings because they simplify the collection and interpretation of images. Dive Insight Exo received a 510(k) nod for its original Iris device in 2021 and added imaging modes and indications to the clearance the following year. The clearances cover handheld portable diagnostic ultrasound systems, similar to Butterfly Network’s iQ, that enable healthcare professionals to measure body structures and fluids in adults and children. Users can view the images on smartphone screens. In 2023, Exo gained additional FDA clearances for AI products. One clearance covered software that uses machine learning to help quantify bladder ...
- Source: drugdu
- 111
- April 28, 2024
FDA Approves Utility Therapeutics’ Pivya to Treat Uncomplicated Urinary Tract Infections in Adult Females

Don Tracy, Associate Editor Pivya has shown efficacy against bacteria strains such as Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus. The FDA announced that it has approved Pivya (pivmecillinam), for the treatment of uncomplicated urinary tract infections (UTIs) in adult females. According to the agency, the approval supports a communal health issue, with close to half of all women experiencing at least one UTI in their lifetime. Before reaching approval, Pivya, which is now available, was given Priority Review and Qualified Infectious Disease Product designations. As part of its support against UTIs, Pivya was designed to fight specific bacteria strains such as Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus. The FDA based their approval on positive results from three different clinical trials comparing various Pivya dosing regimens to placebo, a different oral antibacterial drug, and ibuprofen. In all three trials, Pivya demonstrated a higher level of effectiveness in treating UTIs ...
- Source: drugdu
- 101
- April 28, 2024
FDA Drug Approval Marks a New Day for Treating Pediatric Brain Cancer

Day One Biopharmaceuticals drug Ojemda is now FDA-approved for advanced pediatric low-grade glioma, the most common type of brain cancer in children. The regulatory decision for Ojemda covers a broader swath of patients than a drug combination from Novartis approved for treating this childhood cancer. By Frank Vinluan on April 24, 2024 One quirk of the most common type of pediatric brain cancer is that as a child gets older, the tumors eventually stop growing. The reasons for this tumor senescence aren’t fully understood, but pediatric low grade glioma, or pLGG, still wreaks plenty of havoc until then, says Sam Blackman, a pediatric oncologist and the co-founder and head of R&D for Day One Biopharmaceuticals. “Whether it’s the tumor pressing on an optic nerve creating blindness, damage to the hypothalamus or pituitary gland causing profound endocrine disorders, or pressure on motor structures in the brain causing hemiparesis or loss of ...
- Source: drugdu
- 80
- April 26, 2024
FDA Approves Amneal’s Naloxone Hydrochloride Nasal Spray as an OTC Treatment for Opioid Overdose

Don Tracy, Associate Editor Company aims to provide affordable emergency treatment from overdoses of heroin, fentanyl, and prescription opioids. Amneal Pharmaceuticals announced that the FDA has approved its OTC Naloxone Hydrochloride (HCI) nasal spray for use in counteracting opioid overdoses. As a generic of Narcan, this nasal spray has also been shown to neutralize overdoses caused by heroin, fentanyl, and prescription opioids. With Naxolone officially available, the company stated that this action provides another affordable option to prevent overdoses, which causes more death in people under the age of 50 years than any other cause.1 “With today’s launch, Amneal is proud to help address this public health emergency by providing naloxone nasal spray at an affordable price and without a prescription. Our business is deeply rooted in a commitment to helping others. By enhancing access to naloxone nasal spray, we hope to get this affordable emergency treatment into the hands ...
- Source: drugdu
- 78
- April 26, 2024
FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery

ImmunityBio therapy Anktiva is now FDA approved for treating patients with non-muscle invasive bladder cancer. The novel immunotherapy works by sparking activity from three types of immune cells. By Frank Vinluan Immunotherapy is already a treatment option for bladder cancer, but in many cases, these therapies fail or the cancer comes back. When it returns, the next option is removing the bladder. FDA approval of a novel immunotherapy gives bladder cancer patients an alternative to surgical removal of the organ. The FDA has approved ImmunityBio’s therapy, Anktivo, for the treatment of non-muscle invasive bladder cancer (NMIBC), which is cancer found only on the inner layer of the bladder wall. The regulatory decision announced late Monday covers adults whose disease is unresponsive to Bacillus Calmette-Guérin (BCG), a standard of care immunotherapy for bladder cancer. BCG is a benign type of bacteria. Delivered to the bladder via a catheter, the bacteria induce ...
- Source: drugdu
- 78
- April 25, 2024
FDA Approves Novartis’ Lutathera for Pediatric Patients with Gastroenteropancreatic Neuroendocrine Tumors

Davy James Lutathera is the first FDA-approved treatment for younger patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. The FDA has approved Novartis’ Lutathera (lutetium Lu 177 dotatate) to treat patients aged 12 years and older with somatostatin receptor (SSTR)–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs. The regulatory action makes Lutathera the first therapy specifically approved to treat GEP-NETs in a pediatric patient population.1 “Lutathera is now the very first therapy approved specifically for children with GEP-NETs, offering new hope to young patients living with this rare cancer,” Tina Deignan, Novartis therapeutic area head, Oncology US, said in a press release. “Radioligand therapies (RLTs) have extraordinary potential to shape the future of cancer care. With this approval, we have taken another vital step toward fulfilling that vision, strengthening our commitment to researching and developing the RLT platform across multiple cancer types and treatment settings.” NETs, which are ...
- Source: drugdu
- 140
- April 25, 2024
GenFleet Therapeutics Announces FDA’s Clinical Trial Approval for GFH925 (KRAS G12C Inhibitor) Monotherapy in Phase III Registrational Study Treating Metastatic Colorectal Cancer

SHANGHAI, April 19, 2024 /PRNewswire/ — GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced US Food and Drug Administration (FDA) has granted the clinical trial approval for GFH925 (KRAS G12C inhibitor) in a multi-center, open-label, randomized and controlled phase III study treating refractory metastatic colorectal cancer (CRC) patients. It is the first phase III trial of KRAS G12C inhibitor monotherapy targeting CRC patients worldwide, with GFH925 being the first G12C inhibitor that received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for previously treated advanced CRC. GFH925 was also granted BTD and New Drug Application acceptance with Priority Review Designation by NMPA for previously treated advanced non-small cell lung cancer（NSCLC）patients with G12C mutation. The trial (GFH925X0301) will enroll refractory metastatic CRC patients harboring KRAS G12C mutation who have progressed or experienced disease recurrence on or after at least two prior ...
- Source: drugdu
- 118
- April 24, 2024
FDA Approves Takeda’s Subcutaneous Form of Entyvio as a Maintenance Therapy in Adults with Moderately to Severe Crohn Disease

Don Tracy, Associate Editor Approval was based on positive data from Takeda’s Phase III VISIBLE 2 study, which displayed long-term clinical remission in approximately half of patients with Crohn disease receiving Entyvio. The FDA has approved Takeda Pharmaceuticals’ subcutaneous (SC) form of Entyvio (vedolizumab) as a maintenance therapy for adults with moderately to severely active Crohns disease (CD) following initial intravenous (IV) induction therapy. The expanded approval for an SC form of the drug was based on results from the randomized, double-blind, placebo-controlled Phase III VISIBLE 2 trial, which evaluated 409 patients who were treated with an injection of Entyvio or placebo every two weeks. At the end of the trial, 48% of patients treated with Entyvio experienced clinical remission.1,2 “Crohn’s disease is a complex and usually progressive disease for which an appropriate management plan is critical. My primary goal as a clinician is always to get patients to achieve ...
- Source: drugdu
- 104
- April 23, 2024
Vertex’s pain drug suzetrigine advances in FDA approval process

Vertex Pharmaceuticals’ suzetrigine, previously named VX-548, is steadily advancing along its rolling submission approval pathway okayed by the US Food and Drug Administration (FDA) for moderate-to-severe acute pain. The company announced its plans to submit an NDA following positive Phase III results from two clinical trials investigating the drug in patients who had undergone bunionectomy (NCT05553366) or abdominoplasty (NCT05558410) surgery. Both trials met the primary endpoints, and suzetrigine demonstrated a favourable safety profile with no serious adverse events reported. Vertex has started the rolling submission process and aims to finish by Q2 2024. With FDA fast track and breakthrough therapy designations already secured for the drug to treat acute pain, Vertex is now focusing on neuropathic pain, where positive Phase II results have been achieved. Following a successful end-of-Phase II meeting with the FDA, Vertex is planning a Phase III pivotal programme for patients with diabetic peripheral neuropathy (DPN) later ...
- Source: drugdu
- 85
- April 23, 2024

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.