Posts by rw-admin
VERO Biotech Announces First Patient With COVID-19 Infection Complicating Pulmonary Hypertension Treated with GENOSYL DS, the First and Only FDA-Approved Tankless System for the Delivery of Inhaled Nitric Oxide
VERO Biotech LLC, an Atlanta, Georgia-based biotechnology company focused on saving lives, alleviating suffering, and improving the health economics of care, today announced that the first patient with COVID-19 infection complicating pulmonary hypertension has been treated with its proprietary inhaled nitric oxide (iNO) delivery system, GENOSYL® DS at home. The patient was treated under an emergency IND…
Read MoreOrthofix Completes Acquisition of FITBONE Limb Lengthening System
Orthofix Medical Inc., a global medical device company focused on musculoskeletal healing products, today announced it has completed the acquisition of assets associated with the FITBONE® intramedullary lengthening system for limb lengthening of the femur and tibia bones. The transaction also includes other potential applications of the technology which are in development, including the FITSPINE® system for…
Read MoreBiostage Announces IND Approval from FDA for its Lead Product Candidate Cellspan Esophageal Implant
Biostage, Inc., a bioengineering company developing next-generation esophageal implants, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug application (IND) for the Cellspan Esophageal Implant (CEI) to treat patients with end-stage esophageal disease that require a segmental surgical resection to repair the diseased tissue. The FDA notified…
Read MoreBIOLASE Announces Regulatory Clearance of Laser Bacterial Reduction Therapy Indication for Epic Hygiene Laser
BIOLASE, Inc., the global leader in dental lasers, is pleased to announce the Epic Hygiene™ laser received regulatory clearance for Laser Bacterial Reduction (LBR) therapy indication from the Food and Drug Administration (FDA). This new indication now allows for the early management of periodontal disease utilizing laser light energy to reduce bacteria and thus decreasing…
Read MoreEchoNous, Inc. Announces CE Mark Approval for Its Healthcare AI KOSMOS Platform
EchoNous is very pleased to announce that its KOSMOS platform has been approved for CE Markets thanks to the unbending effort of its engineering, operations and regulatory teams. The company’s engineering team has developed a medical tool that, according to physician feedback, significantly increases provider confidence in bedside diagnostics and clinical decision-making with AI-assistance. The CE…
Read MoreNuclein Speeds Commercialization of First Ever Hand-Held PCR Test to Aid in COVID-19 Pandemic
Nuclein LLC announces plans to expedite the commercialization of its Nuclein™ Hand-Held PCR Test. The company’s disposable, all-in-one, self-test device for infectious disease diagnosis does not require technical expertise and provides battery-powered, sample-to-answer results in under one hour, without the need to mail in a sample. The company anticipates moving into product manufacturing soon, with the…
Read MoreIntuitive Surgical Among 1st Big Medtech Companies to Warn of Costly Pandemic Disruptions
Intuitive said the disruptions it’s felt to date in China, Korea, Taiwan and Italy “do not represent a material portion of our current procedure volume.” n Intuitive’s most critical U.S. market, infections are rising and rapid implementation of mitigation strategies more tangibly threatens the company’s goals for the year. During its most recent earnings call…
Read MoreTransEnterix Receives FDA Clearance for First Machine Vision System in Robotic Surgery
TransEnterix, Inc., a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced the Company received 510(k) clearance for the Intelligent Surgical Unit (ISUTM) that enables machine vision capabilities on the SenhanceⓇ Surgical System. “We are pleased to have received this important clearance earlier than…
Read MoreFDA Clearance Brings RefleXion Closer to Expanding Cancer Treatment Market
RefleXion Medical, a therapeutic oncology company pioneering the use of biology-guided radiotherapy (BgRT)* to treat all stages of cancer today announced it has received marketing clearance from the U.S. Food & Drug Administration (FDA) for stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS) and intensity modulated radiotherapy (IMRT) for its RefleXion™ X1 machine. “We are at the…
Read MoreHologic’s Molecular Test for the Novel Coronavirus Receives FDA Emergency Use Authorization
Hologic, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the Company’s new Panther Fusion® SARS-CoV-2 assay, a molecular diagnostic test that detects SARS-CoV-2, the virus that causes COVID-19 disease. Hospital, public health and reference laboratories can perform the test on Hologic’s Panther Fusion system, a fully automated,…
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