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.
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.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Don’t be like Acme Medical Device Company.
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 […]
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.
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 […]
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
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 […]
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 […]
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 […]
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 […]
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
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 […]
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 […]
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 […]
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, […]
Illumina (NASDAQ: ILMN) got marketing authorization from the U.S. Food and Drug Administration for its diagnostic devices for next generation gene sequencing or NGS. Two of the devices focus on a gene associated with cystic fibrosis. More than 10 million people carry the cystic fibrosis transmembrane conductance regulator gene, according to an FDA statement. The […]