AI Companies That Invest in Better Data Pipelines are Winning Faster Regulatory Approvals — Here’s Why
Medical AI developers who prioritize data early will be the ones crossing the regulatory finish line faster and more reliably.
FDA finalizes new breakthrough device designation rule
The larger regulatory modernization efforts, which include updates to the 510(k) regulatory approval pathway and the DeNovo Clearance review process are part of the FDA's Medical Device Safety Action Plan.
presented by
Enhanced Direct Enrollment: Georgia Access and the Power of Partnership
Across the nation, state-based health insurance exchanges are searching for ways to better serve their communities while making enrollment easier, more personal, and more accessible for everyone.
FDA considering imposing 10-year limit when manufacturers choose older predicates
FDA is modernizing its 510(k) program and one change it is mulling is placing a limit on how old a predicate device is when manufacturers develop a new product showing substantial equivalence.
An alarming device trend: Why getting 510(k) clearance alone is not enough
Don’t be like Acme Medical Device Company.
‘Parallel review’ pilot by FDA, CMS will speed up Medicare coverage for new cancer test
Medicare beneficiaries may get speedier coverage for a newly approved screening test for colorectal cancer under a pilot project in which two federal agencies reviewed the product at the same time instead of one after the other. The Cologuard test, which detects the presence of DNA mutations that may be cancers in the stool, was approved […]
FDA clearance for augmented reality device lets surgeons see each critical step before they make it
Medical device startup, Surgical Theater, was inspired by flight simulators for its augmented reality imaging devices to help physicians prep for surgery. Its Surgical Navigation Advanced Platform (or SNAP) has received FDA clearance, according to a company statement.
presented by
MedCity News Pivot Podcast: How Emergency Departments Are Using Real-Time Data to Improve Outcomes
How can AI benefit and improve patient outcome in the emergency department? Watch the latest episode to find out.
Robotics milestone: FDA clears motorized exoskeleton to help paralyzed patients walk
A motorized exoskeleton designed to help some of the 200,000 people in the U.S. with lower body paralysis has won clearance from the FDA to market the device in the U.S., according to a company and FDA statement. ReWalk Robotics’ device is designed to help people with spinal cord injuries stand upright and walk. ReWalk […]
FDA approves Gauss Surgical’s app that turns iPads into real-time surgical blood loss monitors
A system that uses an iPad camera and cloud analytics to help anesthesiologists monitor how much blood a patient is losing during surgery has gotten the FDA’s OK for use in the operating room. Mobile health startup Gauss Surgical said today it plans to begin rolling out its Triton Fluid Management System to hospitals next […]
FDA clears obstructive sleep apnea implant to overcome adherence issues
Sleep is like sex. Everybody wants it and nobody is getting enough. That’s what Lars Knutsen of Requis Pharmaceuticals said the other day as part of a presentation for a snoring and sleeplessness treatment. But it’s just as relevant for the 18 million people who deal with obstructive sleep apnea. Although continuous positive airway pressure […]
FDA medical device proposal would develop faster path to market for breakthrough tech
Washington routinely comes in for criticism that it doesn’t do enough to support the U.S. medical device industry. But a new FDA proposal would establish for medical devices the equivalent of its breakthrough therapy program for pharma. The proposal would give devices serving a critical need a faster path to market. It has proposed a […]
presented by
RCM Outsourcing: Balancing Human Expertise & Smart Technology
Greenway Health blends smart technology with human expertise to elevate revenue cycle.
Verizon gets FDA clearance to expand remote monitoring platform to iOS users
Verizon has received FDA clearance that will expand a physician-facing patient engagement tool to capture patient data between office visits to the iOS network, according to a company statement. The majority of physicians using mobile devices tend to be iPhone and iPad users. The Converged Health Management platform is a cloud-based tool that transmits patient […]
EarlySense gets FDA device approval for patient monitor update with benchmarking tool
Medical device maker EarlySense has received a green light for an updated version of its FDA-approved patient monitoring device. The tool uses a pad-sized sensor that fits under the mattress to transmit data on respiration and heart rate as well as movement to a bedside monitor and a monitor at a nurse station. The updated […]
Texas medical device company scores FDA nod for hammertoe fixation system
San Antonio, Texas-based BioMedical Enterprises received FDA clearance for its HammerLock Nitinol Intramedullary Fixation System upgrade. The system’s original innovation? No wires. The upgrade has a linear body that allows more bone fusion at the joint, which according to a company statement, offers “enhanced flexibility in positioning and easier reduction.” The implant is made of Nitinol, a […]
FDA to 23andMe: Stop selling spit kits
Star startup 23andMe got slammed with an FDA warning letter Nov. 22. The letter says the healthcare startup’s genetic testing spit kits are being marketed without clearance or approval. It goes so far as to say the diagnostics applications, including “carrier status,” is a medical device usage, and therefore requires premarket approval or de novo […]
BSX scores FDA device approval for drug-eluting stent for coronary artery disease patients
Boston Scientific (BSX) received FDA device approval for its Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, a next-gen polymer drug-eluting stent. The product launches immediately in the U.S. It will be used to treat patients with coronary artery disease. The company boasts the system offers “unparalleled visibility, low recoil, exceptional radial strength and fracture resistance, […]