Royal Philips NV agreed with the U.S. FDA to the terms of a consent decree focused on its Respironics business, following the recall of millions of its devices over the last few years. Although the details of the decree are being finalized, Philips said it will halt the sales of new continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) sleep therapy machines as well as other respiratory care devices in the U.S. until the conditions of the decree are met. Read More
Despite the approval of dozens of antidepression medications, an estimated 30% of individuals who experience major depressive disorder (MDD) fail to respond to treatment despite repeated trials. As about one in eight individuals will experience MDD in their lifetime, investors and researchers have leapt into the gap to find and fund better ways to match treatment to patients, develop non-pharmacological therapies and improve outcomes. Read More
The U.S. FDA’s latest draft guidance for the use of real-world evidence (RWE) is a substantially heftier document than the 2017 final guidance that will shortly become obsolete, and buried in all those extra pages are a few key details. Read More
The biopharma industry lauded the first steps the Australian government has taken to widen access for drugs and devices via reforms to the current health technology assessment process that has remained unchanged for 30 years. Read More
The U.S. FDA has redrafted an existing guidance for third-party reviews of 510(k) submissions to include submissions under the emergency use authorization (EUA) program, which generally speaking should be good news. The problem with the draft is that these third parties will have to interact frequently and substantively with the FDA in EUA reviews, and the lack of prescribed timelines in the FDA draft suggests that while the use of third parties may help the agency manage any future EUA workloads, the total turnaround time for these applications might not be significantly better than was seen during the COVID-19 pandemic. Read More
Inventors affiliated with Nirsense LLC, are designing somatic and cerebral oximetry devices using functional near-infrared spectroscopy (fNIRS). They have filed for patent protection of wearable systems capable of detecting both optical and non-optical biometric properties of a user to determine their cognitive state. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bruin Biometrics, Copan, Magstim, Nuvoair, Si-Bone, Tyber. Read More
