Medtech companies are increasingly looking to the FDA instead of Europe’s CE mark when launching novel products, according to a new report. “Historically, the CE mark has been the preferred route for novel medical technology registration, since its processes were faster, cheaper and more predictable. The situation is now reversed,” wrote the authors of the […]
FDA
FDA clears Quantum Surgical’s robot-assisted tumor ablation tech
Quantum Surgical announced today that it received FDA 510(k) clearance for its Epione interventional oncology robotics platform. Montpellier, France–based Quantum Surgical designed the robot-assisted Epione system to plan, target, deliver and confirm tumor ablation in minimally invasive liver cancer treatment. According to a news release, Epione enables clinicians to perform safe and effective percutaneous tumor […]
How much time and money does it take for FDA 510(k) clearance versus De Novo classification?
If you’re developing a new medical device and want to know how much time and cash it could take to get FDA 510(k) clearance or De Novo classification, a recent report offers some guidance. Boston Consulting Group and the UCLA Biodesign innovation hub questioned leaders at 102 different companies that have achieved registration or approval […]
FDA advisory panel to convene to consider second booster dose
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on April 6 to discuss the potential use of COVID-19 vaccine booster does. Both Pfizer (NYSE:PFE) and Moderna (Nasdaq:MRNA) are seeking to amend the emergency use authorization of their respective vaccines to allow for an additional booster. Pfizer and its partner BioNTech SE (Nasdaq:BNTX) […]
J&J is bringing the world’s first drug-eluting contact lens to market
J&J has a potential alternative to eye drops with its drug-eluting Acuvue Theravision contact lens. As far back as the early 1960s, researchers toyed with the idea of delivering medication through contact lenses. Johnson & Johnson Vision (NYSE:JNJ) Director of Clinica Science Dr. Brian Pall told Drug Delivery Business News that patents back then disclosed how a soft […]
Viatris, Kindeva win FDA approval for first generic version of Symbicort inhalation aerosol
Viatris (Nasdaq:VTRS) and Kindeva Drug Delivery announced today that the FDA approved its generic version of AstraZeneca’s Symbicort. In March 2021, the FDA granted tentative approval to Breyna (Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol) — the first generic version of Symbicort. Today, the agency granted approval for the abbreviated new drug application (ANDA) for the drug-device combination product […]
Diabetes tech is off to a hot start in 2022
Diabetes technology developers have high hopes for the year ahead, some of which have already come to fruition. Change is continuous in continuous glucose monitoring (GCM), with expanded wear-times, improved accuracy and more. Meanwhile, never-ending innovation in insulin delivery is delivering wearable patches and closedloop delivery systems, making insulin management easier for people with diabetes. […]
FDA orders Philips Respironics to improve communications over ventilator recall
The FDA issued a notification order alerting Philips (NYSE:PHG) that its notification efforts on the recall of its ventilators have been inadequate to date. Philips Respironics last year recalled millions of specific ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines due to polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. […]
FDA clears Terumo’s next-gen plasma collection device
Terumo (TSE: 4543) announced today that the FDA cleared its Rika next-generation automated plasma collection system. Lakewood, Colorado-based Terumo designed the Rika system to include safety features that minimize operator errors while collecting plasma in 35 minutes or less. According to a news release, the company developed Rika in response to the industry’s need for […]
FDA, medtech industry groups reach MDUFA V deal
The FDA and medtech industry groups have agreed on a medical device user fee deal. Regulatory Affairs Professionals Society (RAPS) reported that while details are still being negotiated, the FDA reached an agreement on principle on a framework for the Medical Device User Fee Amendment (MDUFA V) on March 7. It will make the deal […]
FDA clears NeuroLogica’s OmniTom Elite with photon-counting detector technology
Samsung Electronics subsidiary NeuroLogica announced today that it received FDA 510(k) clearance for new technology on its OmniTom Elite. Danvers, Massachusetts–based NeuroLogica’s OmniTom Elite computed tomography (CT) scanner now has single-source photon-counting detector (PCD) technology, allowing it to generate spectral CT images at multiple energy levels. NeuroLogica said in a news release that its platform […]