All articles by Staff Writer
Staff Writer
Surmodics Provides Regulatory Update on its Strategy to Submit an Amended Premarket Approval Application for the SurVeil™ Drug-Coated Balloon
EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that it has received formal feedback from the Food and Drug Administration (FDA; the Agency) related to its proposed approach to submit an amended premarket approval (PMA) application for the SurVeil™ drug-coated balloon (DCB).
The Department of Health – Abu Dhabi recognises Abu Dhabi Stem Cells Center (ADSCC) as a centre of excellence in hematopoietic stem cell transplantation
In line with its constant efforts to consolidate Abu Dhabi’s position as a leading destination for healthcare, and to enhance the competitiveness and effectiveness of the healthcare sector for all patients in the Emirate, while providing the highest levels of quality for all patients, the Department of Health – Abu Dhabi, the regulator of healthcare sector in Abu Dhabi, announced Abu Dhabi Stem Cells Center (ADSCC) a subsidiary of PureHealth, the UAE’s largest integrated healthcare platform, as a centre of excellence in Hematopoietic Stem Cell Transplantation.
Seegene declares to share Syndromic PCR technologies to prevent future pandemics
Seegene Inc. a leading South Korean company providing a total solution for PCR molecular diagnostics, declared the commencement of sharing its syndromic PCR technologies all over the world. Seegene aims to partner with nationally reputable companies in each country to develop and manufacture customized syndromic PCR tests locally through access to Seegene’s proprietary technologies and know-how. This effort will enable partnering companies to effectively address potential disease outbreaks and collaboratively prevent future pandemics.
MEDICA 2023 + COMPAMED 2023 on schedule – hot phase of registration and theme planning running with momentum
With a notable increase in the number of exhibitors and a strong boost in the amount of visitors, in November 2022, the internationally leading trade fairs for the medical technology sector and its suppliers, MEDICA and COMPAMED in Düsseldorf, were able to send an important message signalling a new dawn for the market after months of restrictions caused by the pandemic. And they are carrying this momentum into the new year of events (trade fairs will be held on 13–16 November 2023). “The rate of repeat bookings is very high, reflecting customer feedback immediately following MEDICA and COMPAMED 2022. For many companies, contact with international professional medical suppliers is of enormous importance, to give just one example. And this target group has demonstrated a renewed presence among visitors again”, explains Christian Grosser, Director Health & Medical Technologies at Messe Düsseldorf.
DermaSensor Unveils Study Results Demonstrating Ability to Detect Skin Cancer With Device Granted FDA Breakthrough Designation
MIAMI–(BUSINESS WIRE)–DermaSensor Inc., a health technology company equipping primary care physicians (PCPs) with a non-invasive device for use in evaluation of suspicious skin lesions, presented a pooled analysis today from two clinical studies evaluating the performance of the company’s device in detecting skin cancer. In the DERM-ASSESS III and DERM-SUCCESS clinical studies, the device had a sensitivity of 94% for correctly classifying the 338 high risk lesions and a specificity of 23% for correctly classifying 1,681 low risk lesions, all of which were biopsied by physicians for suspicion of skin cancer. Underscoring the effectiveness of DermaSensor’s non-invasive, optical spectroscopy technology, the device met its primary endpoint in the pivotal study (DERM-SUCCESS) of having higher sensitivity than PCPs for all common skin cancers.
AbCellera and RQ Bio Partner to Accelerate the Advancement of New Therapies for Infectious Disease
VANCOUVER, British Columbia & LONDON–(BUSINESS WIRE)–AbCellera (Nasdaq: ABCL) and RQ Bio announced today that they have entered into a strategic collaboration to identify optimal clinical candidates for up to three infectious disease targets selected by RQ Bio, including influenza and cytomegalovirus (CMV). The partnership aims to provide long-lasting infectious diseases medicines to high-risk patients by bringing together RQ Bio’s expertise in infectious diseases and viral evolution with AbCellera’s discovery engine for finding rare, highly potent antibodies.
Cidara Therapeutics and Melinta Therapeutics Announce FDA Approval of REZZAYO™ (rezafungin for injection) for the Treatment of Candidemia and Invasive Candidiasis
SAN DIEGO & PARSIPPANY, N.J.–(BUSINESS WIRE)–Cidara Therapeutics, Inc. (Nasdaq: CDTX) and Melinta Therapeutics, LLC today announced that the U.S. Food and Drug Administration (FDA) approved REZZAYO™ (rezafungin for injection) for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. REZZAYO is the first new treatment option approved for patients with candidemia and invasive candidiasis in over a decade.
STIMVIA Announces Promising Results from Clinical Study Regarding Overactive Bladder
PRAGUE, March 21, 2023 /PRNewswire/ — STIMVIA a pioneer medical technology company focused on the development and commercialization of novel non-invasive neuromodulation for the treatment of lower urinary tract and bowel dysfunction, announces the publication of the safety and efficacy results of peroneal electrical Transcutaneous NeuroModulation (Peroneal eTNM®) delivered by URIS® neuromodulation system in patients with overactive bladder (OAB). The peer-reviewed publication is currently available online and the print article is scheduled to be published in the April issue of an official journal of the American Urological Association, The Journal of Urology.
Launching an Innovative Product, PlaClin-M, for Safe Environments in the Pandemic Era.
SEOUL, South Korea, March 23, 2023 /PRNewswire/ — CodeSteri, a leading provider of disinfection solutions, is proud to announce the launch of PlaClin-M, a revolutionary device designed to help ensure a clean and safe environment in offices, commercial establishments, and public spaces. CodeSteri started from the Korean government project to combat new infectious diseases by the incumbent professor and MD of Hanyang University Emergency Medicine, Seoul.
Merck Provides Update from Open-Label Arm of Phase 2 KeyVibe-002 Trial Evaluating MK-7684A, a Coformulation of Vibostolimab and Pembrolizumab, in Previously Treated Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC)
RAHWAY, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today provided an update on the open-label arm of the non-registrational Phase 2 KeyVibe-002 trial. KeyVibe-002 is evaluating MK-7684A, a coformulation of vibostolimab, an anti-TIGIT therapy, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1 therapy, with or without docetaxel for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progressive disease after treatment with immunotherapy and platinum-doublet chemotherapy. KeyVibe-002, a partially blinded study, was designed with two primary objectives: 1) to evaluate the efficacy of MK-7684A alone compared with docetaxel, a standard of care; and 2) in a blinded assessment, evaluate the efficacy of adding MK-7684A to docetaxel compared with docetaxel alone.