News by subject: FDA

According to Prophecy Market Insights "Generic Sterile Injectables Market accounted for US$ 68.7 billion in 2019 and is estimated to be US$ 196.2 billion by 2029 and is anticipated to register a CAGR of 11.2%" What is the Overview of Generic Sterile...

MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare Compliance,...

Singlera Genomics, a company focused on the application of novel DNA methylation technologies to genetic diagnosis, today announced that it had received Breakthrough Device Designation from the Food and Drug Administration (FDA) for its PDACatch...

HAPPE Spine, a medical device company focused on bringing innovative materials to orthopaedic implants, announces that the company's INTEGRATE-Ctm Interbody Fusion System has received 510k clearance from the FDA....

Suzhou GenAssist Therapeutic Co.,Ltd recently announced its pre-IND application of their first base editing product, GEN6050 and the acceptance by the FDA.   GEN6050 is an in vivo base editing drug that targets exon 50 skipping in the Duchenne...

The first US patient has been enrolled in the SELUTION4SFA Sirolimus DEB study by Dr. Arthur Lee at the Cardiac & Vascular Institute in Florida. This study evaluates SELUTION SLRtm in the treatment of occlusive disease of the superficial femoral...

Norlase, a leading global ophthalmic laser manufacturer developing next-generation laser solutions, today announced it has received both FDA 510(k) clearance and CE Mark approval for the ECHO Green Pattern Laser photocoagulator. ECHO is an...

Olympus Corporation, a global medical technology company committed to making people's lives healthier, safer and more fulfilling, announced today that, for the first time in the U.S., it will demonstrate the EVIS X1tm endoscopy system, its most...

The first US patient has been enrolled in the SELUTION4SFA Sirolimus DEB study by Dr. Arthur Lee at the Cardiac & Vascular Institute in Florida. This study evaluates SELUTION SLRtm in the treatment of occlusive disease of the superficial femoral...

U.S. FDA Breakthrough Device designations are granted to expedite the review of technologies with the potential to greatly impact those suffering from life threatening and debilitating diseases.Cognixion ONE Axon aims to become the first FDA cleared...

Formus Labs today announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for Formus Hip as the first "automated radiological image processing software" for hip replacement pre-op planning. The New...

Today, the U.S. Food and Drug Administration approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the United States. Arexvy is approved for the prevention of lower respiratory tract disease caused by RSV in...

Ricoh USA, Inc. today announced RICOH 3D for Healthcare ? a HIPAA-compliant, ISO 13485 certified 3D medical manufacturing center for the development, design and production of 3D-printed anatomic models ? has received 510(k) clearance from the U.S....

Centricity Vision Inc., a global ophthalmic technology company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the new ZEPTOLinktm IOL Positioning System. The new platform seamlessly integrates...

Aadi Bioscience, Inc. , a commercial-stage biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today announced that it will host a conference...

Vanda Pharmaceuticals Inc. (Vanda) today announced its action against the federal government for the uncompensated taking and misuse of Vanda's trade secrets and confidential information. Vanda alleges that the U.S. Food and Drug Administration...

Low back pain costs the US economy $100B annually. The lifetime prevalence of low back pain is reported to be as high as 84%, and the prevalence of chronic low back pain (CLBP) is about 23%, with 11-12% of the population with CLBP being disabled.A...

Full year 2022 Motion Preservation record revenue was approximately $45 million, achieving the number two total disc replacement (TDR) market position globally.Centinel Spine continues to lead the global lumbar TDR market with an estimated number one...

Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, announced today the FDA clearance of the new EVIS X1 endoscopy system, along with two compatible gastrointestinal endoscopes:...

NeuroBo Pharmaceuticals, Inc. , a clinical-stage biotechnology company on a quest to transform cardiometabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for...

Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy...

Apyx Medical Corporation , the manufacturer of the proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion®, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for...

Today, the U.S. Food and Drug Administration conditionally approved Varenzin-CA1 (molidustat oral suspension), the first drug for the control of nonregenerative anemia associated with chronic kidney disease (CKD) in cats. Nonregenerative anemia can...

Medtronic plc , a global leader in healthcare technology, today announced it has received U.S. Food and Drug Administration (FDA) approval of its Micratm AV2 and Micratm VR2, the next generation of its industry-leading miniaturized, leadless...

The US FDA has granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc's novel MagicTouch Sirolimus Coated Balloon (SCB) for the treatment of Small Vessels (SV) in coronary arteries....

Aquavit Holdings (Aquavit), a biotechnology company focused on the development of botulinum toxin applications, announced today that it has received FDA clearance to initiate clinical trials for DTX-023 and DTX-024, following its submission of...

Padagis today announced the launch of Budesonide 2mg Rectal Foam (generic to Uceris®) with 180-days of Competitive Generic Therapy exclusivity....

OnQuality Pharmaceuticals ("OnQuality"), a targeted oncology supportive therapy company developing innovative medications to address unmet needs in oncodermatology and oncogastroenterology (cancer therapy-induced toxicities occurring in the skin and...

Florida Cancer Specialists & Research Institute, LLC (FCS) today released a case study outlining the evolution of a newly FDA-approved first-line therapy for adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The...

Promis Diagnostics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to EarlyTect BCD as a non-invasive, urine-based diagnosis of bladder cancer from patients with hematuria. Promis...

Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, announced today that Taiwan FDA has approved its Phase II IND application of...

Cooler Heads, a health tech company that has developed an FDA-cleared, portable patient-administered scalp cooling device to help cancer patients undergoing chemotherapy keep their hair, reports accelerated sales growth during its first year on the...

100% (18/18) MCO-010 patients experienced a clinically meaningful improvement in vision-guided mobility (MLYMT), near-field object recognition (MLSDT) or visual acuity (BCVA) (p=0.007 vs sham)94.4% (17/18) MCO-010 patients showed vision improvement...

Innoblative Designs, Inc. (Innoblative), a private medical device company addressing clinical unmet needs for patients with breast cancer, announced today that it received Breakthrough Device Designation from the U.S. Food and Drug Administration...

3M Health Care's innovative 3Mtm Veraflotm Therapy, with both 3Mtm Veraflotm Cleanse Choice Completetm Dressing and 3Mtm V.A.C. Veraflo Cleanse Choicetm Dressing, received the first-ever Food and Drug Administration (FDA) clearance for...

- NEONAVIA is a new, minimally invasive option designed to provide controlled needle insertion, accurate lesion targeting, and high tissue yield from technically difficult lesions as well as difficult to access pathology. - Commercial launch and...

Today, the U.S. Food and Drug Administration approved Vowst, the first fecal microbiota product that is taken orally. Vowst is approved for the prevention of recurrence of Clostridioides difficile (C. difficile) infection (CDI) in individuals 18...

Apotex Corp. has expanded its oncology product portfolio with the launch of Bendamustine hydrochloride injection in the United States....

Ultromics, a leader in the field of artificial intelligence-powered diagnostics for heart failure, has been granted FDA Breakthrough Device Status for its AI-enhanced platform for detecting cardiac amyloidosis....

CardieX Limited (CardieX, the Company), today announced its new arterial health monitor, the CONNEQT Pulse (Pulse), has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). Pulse is the only vital signs monitor targeted at...

Galderma announced today that the U.S. Food and Drug Administration (FDA) has approved Sculptra® (injectable poly-L-lactic acid (PLLA-SCA)) for the correction of fine lines and wrinkles in the cheek area.3...

Ionis Pharmaceuticals, Inc.  today announced that its partner Biogen has received U.S....

Today, ZEISS Medical Technology announced the U.S. Food and Drug Administration (FDA) has approved the CT LUCIA® 621P Monofocal IOL from ZEISS, an aspheric, monofocal, single-piece C-loop IOL. The IOL features the patented ZEISS Optic (ZO)...

Abbott's CentriMagtm Blood Pump, previously cleared for use up to six hours, now can be used to provide longer-term life support to critically ill patients, providing doctors more time to make critical care decisionsAbbott's CentriMagtm Pre-connected...

Avenda Health, an AI healthcare company creating the future of personalized prostate cancer care, today announced its FDA cleared prostate cancer management platform, Unfold AItm, is being used for the first time in a commercial setting with patients...

The maker of NexGard® (afoxolaner), the #1 dog-preferred oral flea and tick protection1, introduces the latest addition to its feline portfolio ? NexGard® COMBO, new broad-spectrum parasite protection specially formulated for feline patientsNexGard®...

YourBio Health, Inc, the developers of the world's first virtually painless push-button blood collection device, announced today that TAP®...

Medtronic plc , the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) approval of its MiniMedtm 780G system with the Guardiantm 4 sensor requiring no fingersticks while in SmartGuardtm technology?. This...

Devices not cleared by the FDA are being sold in the USA! Buying non-FDA cleared devices can cause injury. Spa Sciences launches LEXI after receiving FDA clearance for effective treatment. IPL devices are considered medical devices and have rigorous...

UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that they have received Safer Technologies Program (STeP) designation from the U.S. Food and Drug Administration...