Industry News
Medical Device Industry News
Doug Cassidy Appointed President of the Deep 6 AI Precision Research Ecosystem, the Largest Network of Sites and Sponsors Using AI To Accelerate Research
"Doug Cassidy, formerly our SVP and GM of healthcare organizations, has led the growth of our Ecosystem—from the first site, Cedars-Sinai in 2017, to the launch of our life sciences vertical in 2021, to now,"
Trial Approval for New Pacemaker Aiming to Boost Recovery in Heart Failure
The system has shown a remarkable ability to boost performance and induce cardiac repair mechanisms in subjects with heart failure.
Novo Holdings Leads $105 Mil Financing of Magenta Medical | To Support FDA Approval for World’s Smallest Heart Pump
Novo Holdings reports the funds will be used to advance Magenta’s US clinical programs to support the FDA’s approval of the Elevate™ System, the world’s smallest heart pump.
Asensus Surgical Receives FDA 510(k) Clearance for Senhance Surgical System in Urology
“This FDA clearance marks another milestone for Asensus Surgical and represents an additional indication expansion in the U.S. market,” said Anthony Fernando, Asensus Surgical President and CEO. “The Senhance System's precision and advanced digital capabilities
Radical Catheter Technologies Presents Analysis of Disruptive, Recently FDA-Cleared Endovascular Technology at the Society of NeuroInterventional Surgery 21st Annual Meeting
This new catheter, the first product commercialized from this novel technology platform, is designed to enable access to the blood vessels in the brain for both femoral and radial access. A multi-center analysis of this
Flagship Pioneering Unveils Abiologics to Pioneer Supranatural Biologics, A New Biotherapeutic Class
"For the first time, we are able to imagine and generate chemically synthesized biologics at scale and with increasing programmability, offering a new class of medicines with transformative potential," said Avak Kahvejian, Ph.D., Co-Founder and
Enterprise Therapeutics Doses First Person with Cystic Fibrosis in Phase 2 Trial for Novel Therapy ETD001
Dr John Ford, CEO, Enterprise Therapeutics, said: “The dosing of the first person with CF in our Phase 2a trial of ETD001 represents an incredible milestone, testament to Enterprise’s dedication to advancing a novel approach
Biolyst Scientific Announces New Brand Name to Encompass EMS and Azer | Will Deepen Offerings to Clinical and Research Lab Customers
The new name, ‘Biolyst,’ reflects the essential part the company plays in the Life Sciences discoveries that make life better for all. ‘Bio’ signals where impact is felt – in enhancing and extending life –
Paige Reports 3 UK-Based Hospital Systems Exploring the Power of their AI for Diagnosing Prostate Cancer in Live Clinical Settings
The Paige Prostate Suite is a system of diagnostic AI applications designed to help pathologists detect, grade and measure tumours in prostate biopsies and tissue samples. Pathologists at these three hospital systems are assessing how
Wolters Kluwer Health Launches ClinicalPulse™ | A Simplified Continuing Education Solution for Nurse Practitioners
Rafael Sidi, Senior Vice President & General Manager of Health Research, Wolters Kluwer Health. “In the current healthcare landscape, NPs are facing demanding workloads paired with staying current on the latest medical evidence to ensure
Rapid Medical™ Completes Initial Neurovascular Cases in the USA Following FDA Clearance of Its Active Access Solution
“With DRIVEWIRE, our design goal was to bring new levels of access and control to the interventional suite while improving best-in-class guidewires,” comments Giora Kornblau, Chief Technology Officer at Rapid Medical. “When physicians are looking
Avenacy Announces Launch of Palonosetron Hydrochloride Injection, USP in the U.S. Market
Avenacy's Palonosetron Hydrochloride Injection, USP is available in 0.25 mg/5 mL (0.05 mg per mL) single-dose vials. In line with Avenacy’s mission to champion patient safety and streamline patient care, Palonosetron Hydrochloride Injection, USP will
Agilent Technologies to Acquire North American CDMO BIOVECTRA
BIOVECTRA and Agilent Technologies are fully integrated CDMOs with state-of-the-art facilities that follow current Good Manufacturing Practices (cGMP), a high standard for methods, facilities, and controls used in manufacturing, processing, and packaging of active pharmaceutical
Spryte Medical Receives Breakthrough Device Designation from FDA for Revolutionary neuro Optical Coherence Tomography (nOCT) Technology
“Our engagement with the FDA through the Breakthrough Device and Total Product Life Cycle Advisory Program (TAP), highlights the potential of Spryte Medical’s neuro OCT imaging platform for patients with cerebrovascular disease” said David Kolstad,
TCBP Announces Dosing of 6th Patient in ACHIEVE Study in Patients with Acute Myeloid Leukemia
The ACHIEVE Study UK clinical trial is an open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB-008 in patients with AML or MDS/AML, with either refractory or relapsed disease. ACHIEVE is
Grünenthal Acquires US-company Valinor Pharma and Becomes Global Owner of Movantik®
"As a pain specialist, Movantik is a perfect fit for Grünenthal with our existing customer base and complementary product portfolio", says Gabriel Baertschi, CEO, Grünenthal. "The acquisition of Valinor Pharma strengthens our footprint in the United States,
RedHill Biopharma Strengthens Cash Balance, Settles Obligations and Removes Talicia® Lien
Razi Ingber, RedHill Biopharma and Chief Financial Officer, said: "We are very pleased to reach this smooth conclusion, which strengthens RedHill's cash position and greatly enhances our ability to manage our cash. The Agreement eliminates
Nima Farzan: New CEO at Latigo Biotherapeutics
Nima Farzan brings more than two decades' leadership experience with a strong track record in fundraising and IPOs.
eCential Robotics Receives FDA 510(k) Clearance for Spine Navigation and Robotic-Assistance Device
"This additional FDA clearance is a testament to our relentless pursuit of innovation and excellence in the field of surgical robotics and navigation," said Clément Vidal, CEO at eCential Robotics. "We look forward to continuing
Dasyo Welcomes Medical Aesthetics Industry Icon Domenic Serafino (Dom) as Executive Chair
Domenic Serafino was part of the start-up executive team at Syneron Medical Corp acting as its President of North America and Executive Vice President - Syneron Medical Israel. He was instrumental in helping Syneron IPO in