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
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 […]
How Minnetronix helped Oculogica launch its new EyeBOX concussion diagnostic device
Less than three months after Oculogica won FDA clearance for its portable concussion diagnostic device, contract manufacturer Minnetronix is about to ship the first units to customers. “We are aspiring to be a vital sign for brain health,” Oculogica CEO Rosina Samadani said in an interview. Diagnosing a concussion used to require asking a patient […]
FDA clears Axonics’ recharge-free sacral neuromodulation system
Axonics Modulation Technologies (Nasdaq:AXNX) announced today that it received FDA approval for its new implantable neurostimulator. Irvine, California–based Axonics designed the Axonics F15 recharge-free sacral-neuromodulation (SNM) system with a functional life span of over 15 years at typical stimulation parameters and more than 2 decades at lower-energy settings. The system’s size totals 10 cubic centimeters, […]