The U.S. FDA granted clearance to two tests developed by Thermo Fisher Scientific Inc. to predict preeclampsia, Brahms PIGF plus Kryptor and Brahms sFlt-1 Kryptor. Both had previously received breakthrough designation. Preeclampsia, a hypertensive disorder, is the leading cause of maternal and fetal mortality and morbidity across the globe.
Amsterdam-based Royal Philips NV has posted the data from the complete set of third-party testing of the polyester-based polyurethane (PE-PUR) sound abatement foam used in its first-generation CPAP and other devices, and the news is not good for the U.S. FDA. These third-party evaluations have concluded that the foam used in these first-generation devices is unlikely to exert any “appreciable harm” to patients, a conclusion that runs directly counter to the FDA’s implicit argument about the foam.
A surgical navigation platform developed by Proprio Inc., that is intended to replace traditional surgical technologies which produce harmful radiation and can impede surgical workflow, won U.S. FDA 510 (k) clearance.
Abbott Laboratories received U.S. FDA approval for an expanded indication for its spinal cord stimulator (SCS) devices to include treatment of chronic back pain for individuals who have not had or are ineligible for back surgery. The FDA based its decision on the positive results from the DISTINCT study which showed that 85.2% of patients implanted with the SCS devices achieved significant reduction in back pain compared to 7.1% of those who received conservative medical management.
Quantum Surgical SAS has obtained an extension to the FDA authorization covering its Epione robot, which can now treat abdominal cancers. “This decision now allows physicians to treat all abdominal tumors at an early stage and will ramp implementation of our Epione robotics solution in the U.S.,” said Bertin Nahum, CEO and co-founder of Quantum Surgical. Marketed in Europe and the U.S., the Epione robot has already been used to treat more than 150 patients with liver or kidney cancer.
Centricity Vision Inc. received U.S. FDA clearance for technology designed to integrate with modern phacoemulsification or “phaco” systems that use ultrasound energy to emulsify the eye's native internal lens during cataract surgery. Centricity’s new Zeptolink interocular lens (IOL) positioning system is used in conjunction with phaco systems to surgically remove the natural lens of the eye as the first step in cataract surgery.
Creative Balloons GmbH has changed its name to Advanced Medical Balloons GmbH and is bringing its fecal management system, Hygh-tec, to the U.S. market after receiving clearance from the U.S. FDA. Hygh-tec is a microscopically thin polyurethane balloon catheter system which enables reliable, sealed access to the colon preventing fecal leakage from patients in intensive care units.
A subcommittee of the U.S. House Ways and Means Committee met to review the status of policies for novel medical devices and drugs, but a partisan rift was immediately evident at the hearing. House Democrats were generally in favor of more drug price negotiation power for the federal government and opposed to immediate Medicare coverage of breakthrough medical devices while Republicans generally steered in the opposite direction, suggesting that drug and device makers should not expect clear legislative sailing over the course of the 118th Congress.
An increasing number of European med-tech companies are first seeking regulatory approval from the U.S. FDA because of the growing backlog and frustrations with requirements under the new regulatory framework of the EU Medical Device Regulation (MDR), which has been described as “not working.”
The regulatory record for successful replacements of the human meniscus is thin, but the latest attempt came up short as a U.S. FDA advisory committee voted 6-2 that the benefits of the Nusurface device by Active Implants LLC did not present an acceptable benefit-risk ratio. The device is commercially available in both the European Union and in Israel, however, suggesting that Memphis, Tenn.-based Active will not give up on the massive U.S. market, which offers a patient population that will undergo a tsunami of total knee replacements in the decades ahead unless a solution for the epidemic of cartilage degeneration can be found.
