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MEDICAL DEVICE NEWS MAGAZINE

Breaking News

Acumen Diagnostics’ PCR Capabilities to Tackle Omicron COVID-19 Variant

In addition to detecting COVID-19 positive cases infected with the Delta variant, the Company's proprietary PCR test kits are able to detect COVID-19 positive cases infected with the Omicron variant as well.

G Medical Innovations Holdings Ltd. Scheduled to Launch Covid-19 Testing Centers in California as Part of New Direct-to-Consumer Initiative

“By offering Prizma at our Covid19 testing sites we are empowering consumers to measure and monitor their vital signs post testing, in the comfort of their own home,” said G Medical CEO Dr. Yacov Geva.

Rhythm Therapeutics rebrands as Inomagen Therapeutics

The company is headquartered at Portal Innovations, a life science focused venture development engine located in Chicago's Fulton Market neighborhood.

Biotium Expands Multiplexing Options for Probe-based qPCR with Unique Red qPCR Dye

The release of EvaRuby™ Dye adds to Biotium’s industry-leading catalog of qPCR reagents for life science research.

Applied BioCode Launches 28 New Fungal Analyte Specific Reagents in the US

These ASR products utilize the company’s proprietary Barcoded Magnetic Bead (BMB) technology for specific detection of targeted organisms.

Arctic Vision Announces First Patient Dosed in Phase III Study of ARVN001 for Treatment of Macular Edema Associated with Uveitis (UME)

The leading principal investigator of the Phase III study of ARVN001 is Professor Peizeng Yang, an uveitis expert in China.

Aditum Bio Announces Formation of Motric Bio

Motric Bio is the seventh company formed by Aditum Bio.

FUJIFILM Irvine Scientific Expands its Armstrong R&D Cell Culture Center of Excellence to Accelerate New Product Development and Broaden Service Offerings

"The expansion project will more than double the R&D facility’s footprint and will allow for more enhanced technical collaboration between R&D experts and customers to develop personalized solutions and enhance partnership opportunities,” said Bob Newman, chief scientific officer, FUJIFILM Irvine Scientific.

Salignostics Set to Commercialize World’s First Rapid Saliva-Based Pregnancy Test Kit

Revolutionary saliva-based detection technology proven in the discovery of COVID-19 is now able to reveal the pregnancy hormone in saliva.

GlycoPath Inc. Launches Glycan Imaging Kit for Glycoproteomic Analysis of Clinical and Research Samples

Dr. Richard Drake, CEO at GlycoPath, said: "This kit is very applicable to many types of research, from tissue imaging to biofluid profiling, and it can be adaptable to many types of platforms and assays with glycans as a readout. This is an out-of-the-box solution for N-glycan imaging analysis designed for both new and experienced users."

NEW GT-Digital SARS-CoV-2 Variant Assay Panel for QIAcuity® Wastewater Surveillance Kit (Patent Pending)

In addition to GT Molecular's initial offering for the QIAcuity® that targets N1 and N2, the company has released a new panel for the SARS CoV-2 Variants of Concern.

OptraSCAN & Inspirata Announce Technical Partnership

This partnership will allow pathology labs, healthcare networks and hospitals to acquire digital pathology images without any upfront cost and display them within a world-class workflow solution.

New Acquisitions & Mergers

Insightful Science Acquires LabArchives to Expand its Electronic Lab Notebook and LIMS Solutions for Scientific Discovery

LabArchives is a best-in-class solution at the intersection of the ELN, LIMS, and Lab Informatics technology already used by more than 600,000 researchers in leading research organizations.

X-Chem Acquires ComInnex

Matt Clark, Ph.D., CEO of X-Chem said, “The acquisition of ComInnex further extends X-Chem’s expertise and scale of DEL services to help biopharma clients of any size efficiently unlock exponential possibilities in small molecule drug discovery.”

Growth / Development

Syncona co-leads Series B Financing in Quell Therapeutics of Up to $156 Million

Quell is developing engineered Treg cell therapies, seeking to harness the suppressive capacity of Tregs by leveraging their potential to downregulate the immune system, to treat a range of applications, the first of which will be in solid organ transplantation.

Viome Life Sciences Raises $54M

"Viome is rapidly scaling to become a global leader in the longevity space, to promote better health outcomes today and our future generations, with exceptional innovation," said Harish Consul, Founder & CEO, Ocgrow Ventures. 

Clinical Trials

SOPHiA GENETICS Announces Launch of DEEP-Lung-IV Multimodal Clinical Study

SOPHiA GENETICS' DEEP-Lung-IV clinical study aims to predict immunotherapy treatment response at first evaluation at the individual patient level using data across multiple modalities including genomics, radiomics, clinical and biological data.

Updated Data from Lead Program CUE-101 for the Treatment of Recurrent/Metastatic HPV+ Head and Neck Cancer and Additional Pipeline Progress Reported

Monotherapy data further enhances confidence in CUE-101 potential as single agent therapeutic in the refractory/metastatic human papillomavirus positive head and neck squamous cell carcinoma (HPV+ HNSCC) setting

Executives on the Move

Dr. Patrice Harris and Dr. Michael Mina of e-Med On President Biden’s Plan to Protect the American People Against COVID-19

Together they offer eMed's support of wider access and adoption of at-home rapid testing.

Sera Prognostics Announces the Appointment Of Sandra A.J. Lawrence To The Sera Prognostics Board

"I am thrilled to join Sera's board and work on its strategy to provide actionable information and improve the opportunity for better short- and long-term quality of life for babies," said Sandra A. J. Lawrence. "It is exciting for me to help Sera produce innovative and comprehensive solutions for pregnant women, designed to benefit women and babies across all communities and segments of societies, here in the United States and abroad."

Dr. Alex van Belkum Appointed BaseClear Chief Scientific Officer

Alex Van Belkum will lead BaseClear’s science and innovation arm together with Innovation Manager Walter Pirovano and a team of PhD-level Product Managers.

FDA Cleared Devices & News

Cresilon Announces FDA 510(k) Submission For Human Use Hemostatic Gel Technology

"This FDA submission marks an important milestone for Cresilon in our commitment to significantly improve the standard of care in wound treatment," said Joe Landolina, CEO of Cresilon.

Gelesis’ FDA-Cleared Weight Management Approach, Plenity®, Now Broadly Available

Gelesis, a consumer-focused biotherapeutics company, announced Plenity®, an FDA-cleared weight management approach, is now broadly available across the United States to adults who meet...

Pharma

ZetaMet™ Receives Breakthrough Device Designation from the FDA for RX of Metastatic Bone Cancers

“We are pleased to receive this important designation from the Agency and look forward to partnering with them,” said Joe C. Loy, CEO of Zetagen Therapeutics.

IFM Therapeutics Announces Extension of Collaboration Agreement for cGAS-STING Subsidiary, IFM Due

"At IFM, we believe innate immune biology offers a multitude of genetically-validated, clinically-relevant targets and pathways across several therapeutic areas," said H. Martin Seidel, Ph.D., CEO of IFM Therapeutics.