Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Atricure, Cerapedics, Celltrion, Lumenis, Soliton, Sommetrics.
CMS has posted the draft Medicare inpatient rule for fiscal year 2022, replete with the usual controversies over reassignment of procedures under the Medicare diagnostic grouping system. One bit of good news is that the agency may carry over several expired new technology add-on payments (NTAPs) into the coming fiscal year, a move prompted by the difficulty of collecting claims data from fiscal year 2020 due to the COVID-19 pandemic.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Task force affirms hypertension screening recommendation; FDA adds to list of recognized standards; New Jersey DOJ office announces $93M fraud take-down.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: International Medical Solutions, Magventure, Pixee Medical.
The FDA has granted breakthrough device designation to Fractyl Laboratories Inc. for Revita DMR, a duodenal mucosal resurfacing treatment for patients with type 2 diabetes. The company recently launched the pivotal REVITA-T2Di clinical trial to evaluate the treatment in this population, in hopes it will offer a new option for people with the metabolic disease.
The FDA’s premarket review mechanisms for class II medical devices may strike some as little more than so much regulatory esoterica, and several courts have ruled that information about the 510(k) process is inadmissible during jury trials due to the possibility of sowing confusion among jurors. An appellate court in New Jersey has ruled that such an exclusion of evidence is prejudicial in a case involving surgical mesh manufactured by two device companies, however, opening a larger debate about the propriety of such exclusions in product liability litigation for medical devices.
PARIS – One month before the Medical Device Regulation (MDR) comes into force in the EU, the European Association of Notified Bodies (Team-NB) has released the results of its latest annual survey. This survey of CE-marked medical devices compiled data from 26 notified bodies who were members of Team-NB at the end of 2020. According to Team-NB’s 2020 survey, a total of 18,784 valid CE certificates had been issued by last year, representing an increase of 35% over 2010.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: GAO denies Roche challenge of Air Force request; NICE updates atrial fibrillation guidelines.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Biological Laboratories, Fractyl Laboratories, Johnson & Johnson Vision.
The Medical Device Innovation Consortium (MDIC) has been hard at work on the Make CAPA Cool program in an effort to beef up device makers’ corrective and preventive action (CAPA) programs. Kathryn Merrill, regulatory program director for Dublin-based Medtronic plc, said on an April 26 webinar that participants in the program have shaved CAPA times from 381 days to as few as 63 days, an improvement that industry hopes will ward off warning letters and product quality issues.