Posts by cstephenson@legacymedsearch.com
Biostage 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,…
Read MoreThe Consult Station: Front-Line Detection and Triage to Contain the Spread of Covid-19
H4D, a leading global telemedicine company, is joining the international effort to fight the global coronavirus pandemic. H4D is providing hospitals with a fast, efficient and reliable solution to improve patient flow management in the emergency department. The Consult Station® allows the 4 key vital parameters to be taken in 5 minutes, rapidly identifying the…
Read MoreEndologix Announces FDA Approval of AFX Endovascular AAA System
Endologix, Inc. (Nasdaq: ELGX), developer and marketer of minimally invasive treatments for aortic disorders, announced today that it has received U.S. Food and Drug Administration (FDA) approval for its next generation product, the AFX™ Endovascular AAA System, for the treatment of abdominal aortic aneurysms (AAA). Endologix is introducing AFX at the Annual Meeting of the Society…
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