Zebra Medical Vision, the deep-learning medical imaging analytics company, announced today its sixth FDA 510(k) clearance for its mammography solution, HealthMammo, which has already received a CE mark. Zebra Medical’s algorithm empowers breast radiologists by priori.. Read the news
The price for U.S. private insurance companies will be $520 per vial, the drugmaker said, which equates to $3,120 per patient for a treatment course using 6 vials of remdesivir.This is below the $5,080 per course recommendation by U.S. drug pricing research group, the I.. Read the news
SFA Therapeutics, Inc. is pleased to announce that the US FDA has provided approval to conduct a clinical trial (officially referred to as an IND) for the treatment of "the appearance of the structure of skin with plaques due to psoriasis." SFA plans to expand the .. Read the news
Nordic Nanovector is evaluating the opportunity to develop Betalutin® as a single-agent treatment for MZL, a rare type of non-Hodgkin's lymphoma (NHL). Betalutin® has demonstrated a very promising clinical effect in nine MZL patients in the Phase 1/2a LYMRIT 37-01.. Read the news
Grifols, a global firm for development of therapies with plasma-derived proteins with a track record of more than 100 years dedicated to enhancing people's health and well-being, today announced the start of production of its anti-SARS-CoV-2 hyperimmune immunoglobu.. Read the news
GeneQuantum Healthcare focuses on the research and development of various innovative bioconjugate drugs via its innovative LDC technology and the international first-class iLDC platform. The company's iLDC platform utilizes an enzyme-catalyzed intelligent continuou.. Read the news
MIVI Neuroscience, a developer, and marketer of precision stroke therapy devices utilized by neurointerventionists around the world, announced today that the FDA has determined the company has provided sufficient data to support initiation of a human clinical study of t.. Read the news
Ascend, the dialysis testing laboratory, has begun performing antibody testing for COVID-19. Ascend is one of the first to offer COVID-19 total antibody testing on the Siemens high throughput platform, which can be combined with a patient's regularly scheduled tes.. Read the news
Hikma Pharmaceuticals PLC (Hikma), the multinational generic pharmaceutical company, has launched Dicyclomine Hydrochloride Oral Solution, USP, 10 mg/5 mL, an AA-rated version of Bentyl®1 Oral Syrup, 10 mg/5 mL in the United States through its US affiliate, Hikma.. Read the news
4DMedical, an Australian medical technology company specializing in medical imaging innovation software, announced today it has received clearance from the U.S. Food & Drug Administration to market its XV Technology™, a patented four-dimensional lung imaging proce.. Read the news
Hikma Pharmaceuticals PLC (Hikma), the multinational generic pharmaceutical company, has announced that its wholly owned U.S. subsidiary Hikma Pharmaceuticals USA Inc. has received approval from the US Food and Drug Administration (FDA) for its Icosapent Ethyl Capsul.. Read the news
Approval of the HeartLight X3 System came as a result of a comprehensive submission, including outcomes from the study of 60 HeartLight X3 patients. In this pivotal confirmatory study, the X3 System achieved very rapid pulmonary vein isolation (PVI), in as few as three .. Read the news
Viracor Eurofins, Inc. (Viracor) an infectious disease testing laboratory for more than 35 years, announced the launch of its antibody assays for Coronavirus (COVID-19) SARS-CoV-2. The CAP-accredited and CLIA/NY State-certified laboratory has been at the forefront o.. Read the news
Diverse Biotech, Inc. www.diversebiotech.com has announced the U.S. Food & Drug Administration (FDA) has granted an orphan-drug designation request for one of its investigational new therapies for treatment of newly diagnosed glioblastoma, in conjunction with standard.. Read the news
BioReference Laboratories, Inc., an OPKO Health company, announced that beginning today it will offer antibody blood tests to detect an immune response after infection with the COVID-19 virus. Antibody testing and molecular diagnostic testing for COVID-19 are available .. Read the news
On April 8, 2020, Shanghai Green Valley Pharmaceuticals, China received the formal decision letter from the US Food and Drug Administration (FDA) on the Investigational New Drug (IND) application for the GV-971 international multi-center Phase III clinical study... Read the news
Lubrication Specialties Inc. (LSI) announces the immediate production and availability of an 80% alcohol, non-gel hand sanitizer formulated to the specifications of the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Availab.. Read the news
The Miami Distilling Company, best known as the producer of ultra-premium Toast™ vodka, announced today that they have begun producing and shipping hand sanitizer to meet the growing local and national demand in response to the novel coronavirus pandemic. The compan.. Read the news
A new clinical trial is being announced today that could significantly increase the rate of recovery for COVID-19 patients with underlying health conditions and save lives! Circularity Healthcare's trial will help some of the most at-risk patients suffering from .. Read the news
Sea Buckthorn Farm is launching a complete premium quality sea buckthorn oil blend – a whole bundle of nutrition, more than any isolated source can provide. Its seeds and berry pulp contain approximately 190 bioactive substances, the majority of which are e.. Read the news
According to the website of the U.S. Food and Drug Administration ("FDA"), Shanghai Fosun Pharmaceutical (Group) Co., Ltd ("Fosun Pharma"; Stock Code: 600196.SH, 02196.HK) has received emergency use authorization (EUA) from FDA for its COVID-19 RT-PCR detection kit.T.. Read the news
RELIEF THERAPEUTICS Holding AG (SIX: RLF) "Relief", together with NeuroRx, a Delaware Corporation, have filed an Investigational New Drug (IND) Application with the US FDA for a phase 2 trial of RLF-100 (Aviptadil) in the treatment of Acute and Moderate Respiratory Dist.. Read the news
Tesla bought hospital ventilators in China and shipped them to the United States, CEO Elon Musk said on Tuesday.Tesla’s purchase comes as governments across the globe appeal to automakers and aerospace companies help procure or make ventilators and other medical equip.. Read the news
Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) today announced topline results from a clinical study evaluating the safety and pharmacokinetics of Caldolor® (ibuprofen) Injection in children ranging from birth to six months of age. Topline results from this study .. Read the news
A large number of people across the people are unaware about the symptoms atrial fibrillation, which is one of the most common type of heart disorder. And thus the condition is left untreated and lead to the possibility of stroke. According to report by Eastern AHSN, th.. Read the news
TheraLight, LLC, an FDA-registered manufacturer and distributor of cutting-edge light therapy products, recently announces it has acquired the assets from Theralight, Inc., a manufacturer of phototherapy devices. The assets acquisition includes a portfolio of product.. Read the news
One of the key reason that probably interests cybercriminals to healthcare industry is patients’ personal data including name, age, date of birth, number, etc. The hackers use these data for stealing the identity of any patient, which is also referred to as identity t.. Read the news
Geneyork Pharmaceutical, a privately held specialty pharmaceutical company which develops, contract manufactures, and sells pharmaceutical finished products, today announced the U.S. launch and commercial shipment of generic version of Deltasone® (Prednisone) Tablets w.. Read the news
Blue Cross Blue Shield of Massachusetts ("Blue Cross") today launched a pilot program to offer members suffering from knee and low back pain an at-home treatment device designed to reduce pain and improve quality of life. The pilot entails eligible members using Apos.. Read the news
The increasing cost of medicine for consumers of the U.S. came back in focus in 2018, as soon as President Trump’s government revealed an extensive policy proposal challenging drug prices, facilitating to reignite the deliberation over the amount patients are paying f.. Read the news
Luye Pharma Group has announced submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for LY03005, a new chemical drug for the treatment of major depressive disorder. It is also the second U.S. FDA NDA submission in the central nervou.. Read the news
Dova Pharmaceuticals, Inc., a wholly owned subsidiary of Swedish Orphan Biovitrum AB (publ) (Sobi™) has been granted Orphan Drug Designation[1] (ODD) by the US Food and Drug Administration (FDA) for avatrombopag for the potential treament of Chemotherapy-Induced Thro.. Read the news
The EU’s new MDR that is expected to get live by the mid of 2020, has major consequences for labelling in every single form.Usually, manufacturers of medical devices get their labelling including Instructions-For-Use (IFU) flyers & content of their website done by se.. Read the news
Elekta (EKTA-B.ST) today announced that it has received 510(k) premarket notification from the U.S. Food and Drug Administration for the use of diffusion-weighted MR images (DWI) obtained with Elekta Unity to be interpreted by a trained physician. This expands the clini.. Read the news
CBD is being advertised in various types of product, such as capsules, oil drops, syrups, food products like chocolate bars & teas as well as topical lotions & creams. A few have publicized it having several homeopathic properties like anxiety, relieving pain and even b.. Read the news
3D Systems (NYSE:DDD) announced that its new biocompatible denture material, NextDent® Denture 3D+, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The combination of this new dental 3D printing material, NextDent 5100 dental 3D prin.. Read the news
Out of an abundance of caution, Johnson & Johnson Consumer Inc. (JJCI) announced that it is initiating a voluntary recall in the United States of a single lot of its Johnson's Baby Powder in response to a U.S. Food and Drug Administration (FDA) test indicating the.. Read the news
Subtle Medical, a healthcare technology company focused on improving the quality, efficiency, and accessibility of medical imaging, announced today 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market SubtleMRTM. SubtleMR is an image processing so.. Read the news
Narcolepsy Market To Account To US$ 4,537.9 Million By 2027 From US$ 2,026.8 Million In 2018. Jazz Pharmaceuticals, Inc., Novartis AG and TEVA Pharmaceuticals Industries - Notable Market Participants in Narcolepsy Market. The narcolepsy market is highly competitive in.. Read the news
The exon is part of a genome which is responsible for making 1 or 2 percent of the entire genome of a person. All of the exon in a genome are together known as the exome. And thus, sequencing is of these is known as whole-exome sequencing. The whole-exome sequencing all.. Read the news
The incidence of fungal infections due to numerous diseases has increased over the last few decades. Furthermore, bloodstream infection incidence is bimodal, with adult people and premature babies having the maximum risk. Cancer treatment using chemotherapy and radiatio.. Read the news
CENTOGENE is the leading rare disease organization focusing over the transformation of genetic, biochemical and clinical data to medical solutions for their patients. Also, they are very much focused at getting rational decisions in terms of treatment along with adva.. Read the news
In the recent years, urinary catheters market has progressed significantly. The global market for urinary catheters is anticipated to grow from US$ 2,526.8 Mn in 2017 to US$ 4,811.0 by 2025 at a CAGR of 8.6%. The increasing prevalence of urinary incontinence backed by r.. Read the news
According to a new market research study titled ‘Helicobacter Pylori Non-Invasive Testing Market to 2027 – Global Analysis and Forecasts by Test Type, Test Method, End User and Geography. The global Helicobacter pylori non-invasive testing market is expected to rea.. Read the news
Progressive growth of Sports Medicine is Expected to Accelerate the Soft Tissue Repair Market from 2018 to 2025.In recent years, there has been a rise in the cases of sport injuries and Road As per the data published by the Ministry of Justice, UK, there is a rise in th.. Read the news
The global food safety and hygiene compliance market is accounted to US$ 9.1 Bn in 2018 and is expected to grow at a CAGR of 6.0% during the forecast period 2019 - 2027, to account to US$ 15.3 Bn by 2027.The food safety and hygiene compliance market is experiencing high.. Read the news
The market for nuclear medicine/radiopharmaceuticals is expected to grow, owing to factors such as rising prevalence of chronic diseases, alpha radioimmunotherapy-based targeted oncology treatment and advancement in imaging technologies using radiopharmaceuticals play v.. Read the news
Ortho Clinical Diagnostics, a global leader in vitro diagnostics, announced that it’s VITROS Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (VITROS HIV Combo test) was granted pre-market approval by the U.S. Food and Drug Administration for use on Ort.. Read the news
Increasing incidence of lifestyle diseases is expected to drive the growth of the market. However, strict government guidelines is expected to hamper the growth of the market. Over the past few decades, human microbiome is related to lifestyle diseases like cancer, diab.. Read the news
The breast implants market is highly competitive in nature with considerable number of players, having a high level of consolidation overall revenue share. Most of the companies operating in the breast implants market are present globally and have wide distribution and .. Read the news
There has been a gradual increase in the number of preterm births from last few years. As per the World Health Organization (WHO), premature birth is a leading cause of death among the child below 5 years of age. It may be due to early induction of labor or caesarean bi.. Read the news
The gastric balloon is a niche market in nature with limited number of players, having considerable revenue in the market. Most of the companies operating in the gastric balloon market are offering their products in the European and the Middle East region, whereas, only.. Read the news
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