Clinical Trials
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New UAE Regulator Calls On Drug and Device Companies To Help Shape Mandate
Facilitating and strengthening R&D, intellectual property rights protection and drug safety are among the goals of the soon-to-be-launched Emirates Drug Establishment. Despite the name, the entity is also responsible for device regulation.
Sex-Based Diversity In Clinical Trials Can And Will Improve – An IWD Perspective
As a three-time cancer survivor and someone who has participated in a device trial, Alicia Staley, Medidata’s VP of patient engagement, is no stranger to innovative treatments. She spoke to Medtech Insight about how both the gender and socioeconomic diversity of trial participants could be improved.
Identifying The Barriers To Digital Clinical Trial Technologies
Digital clinical trials, a trend sparked by the COVID-19 pandemic that has held the biopharma industry’s interest, are changing the way patients interact with research and improving access, says Medable’s CEO.
Cardio Conversations: ‘Much More Than Just A Patch,’ iRhythm CEO Blackford Talks AI Arrhythmia Diagnostics
iRhythm CEO Quentin Blackford returned to Medtech Insight’s Cardio Conversations podcast to talk about the launch of his company’s new Zio monitor patch supported by a sophisticated neural network. He also addressed the company’s plans to improve its position in the mobile cardiac telemetry market, the impact of pulsed field ablation on the cardiac monitoring business, and more.
News We’re Watching: New Cybersecurity Standard; CMS Prodded On TCET; Olympus Scopes Recalled
This week, NIST published a new version of its international cybersecurity standard; SeaStar Medical’s kidney device got an HDE; and the FDA announced safety issues for DT MedTech LLC, operating room tables, and GE incubators.
'There Is Work To Do:' Sean Salmon Discusses Medtronic's Recent Hard-Won Cardio Breakthroughs
Medtech Insight caught up with Sean Salmon, the president of Medtronic's cardiovascular business, to talk about the long-awaited FDA approval of the Symplicity Spyral renal denervation system, recent approvals of the PulseSelect pulsed field ablation system and extravascular ICD, and the company's plans for transcatheter aortic valve replacement.
News We're Watching: Tricuspid Procedure Boom, Boston Scientific Borrows $2Bn, And More
Medtech Insight's News We're Watching highlights some recent business and R&D developments you may have missed. This week, GE Healthcare and Biofourmis announced a deal to collaborate on virtual care; Cleerly touts a new CPT code for its Ischemia cardiac diagnostic software; Boston Scientific announced how it plans to pay for Axonics; a Wells Fargo survey suggests the market for transcatheter tricuspid valve repair and replacement will grow faster than previously imagined; Virtual Incision earns FDA de novo authorization for its MIRA miniaturized surgical system for colectomy procedures; and MMI and Fabric announce major financing rounds.
News We’re Watching: Smart Watch Blood Glucose Warning, $100M For Women’s Health, Zimmer Surgical Robot Clearance
This week, the FDA reminded consumers that smart watches and rings are not blood glucose monitors; First Lady Jill Biden announced a $100M women’s health initiative; and the Zimmer ROSA Shoulder System got FDA clearance.
Denmark Leads The Way On Speeding Up Approvals For Drug/IVD Combination Trials
While an EU-level project is underway to address delays to drug trials that are conducted in combination with IVD performance studies, Denmark has streamlined its processes to address the issue at the national level.
Third-Party Labs May Produce False Data, FDA Warns
The US agency is warning manufacturers about an alarming device submission trend toward unreliable data generated by third-party labs.
News We're Watching: Accenture Expects 'More Human' Tech, Cardiac Genetic Tests In Walmart; And More
Medtech Insight's News We're Watching highlights a few noteworthy industry developments you might have missed: Accenture's new Vision Report addresses the future of "more human" tech in health care; Efemoral secures FDA's breakthrough status for its bioresorbable peripheral stent; Impulse Dynamics secures $135m to support its cardiac contractility modulation; PrecisionLife and Metrodora announced a partnership to address chronic diseases including long COVID; Cardio Diagnostics launches its cardiac epigenetic/genetic tests in a Walmart near Chicago.
AAOS: Study Finds Robots Do Not Help Knee Revisions; Analysts Bullish On Ortho; More
Studies presented at the American Academy of Orthopedic Surgeons' annual meeting in San Francisco found that robotics did not improve revision rates in total knee arthroplasty surgeries and chatbots do not consistently provide accurate information to orthopedics patients. Wall Street analysts came away from the meeting bullish on the joint reconstruction surgery market. More news from the 12-16 February meeting.
Abbott Moves Forward With TriClip G4 TTVR After Successful Advisory Panel
After an FDA advisory panel voted in support of Abbott’s PMA for the TriClip G4 transcatheter tricuspid valve repair device, Medtech Insight discussed the panel’s review with Barathi Sethuraman, DVP for clinical affairs for Abbott’s structural heart business.
FDA Clears AI Software Designed To Detect Early Signs Of Fatty Liver Disease
The US FDA has cleared an AI software diagnostic product from an Israeli firm designed to detect a type of fatty liver, which is often an early indication of serious liver disease.
News We're Watching: Layoffs At Illumina, Canary's Heart Sensor; SCS To Help Amputees; Samsung's Apnea Monitor
Medtech Insight's News We're Watching highlights a few medtech industry developments we are following: Illumina will lay off 111 people from its San Diego headquarters as it comes to grips with the impending Grail divestiture; a team of researchers have devised a way to use spinal cord stimulators to give amputees "feeling" in a leg that is no longer there; Samsung earns FDA de novo for sleep apnea monitor.
FDA AdCom Will Scrutinize Placebo Benefit Of Abbott’s TriClip G4 TTVR
An FDA advisory panel will discuss Abbott’s PMA for the TriClip G4 transcatheter tricuspid valve repair device on 13 February. The group’s discussion will likely focus on the lack of a clear mortality or hospitalization benefit in the TRILUMINATE pivotal trial.
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