Neurotech startup Synchron Inc. connected its brain implant to Apple’s Vision Pro headset, enabling patients with limited physical mobility to control the device using only their thoughts. Synchron is building an endovascular brain-computer interface designed to help patients with paralysis operate technology like smartphones and computers with their minds.
In Pumpkinseed Technologies Inc.’s first public patenting, the company’s co-founders describe their development of new proteomics platform that merges nanotechnology, biochemistry, silicon photonics and machine learning for high-resolution phenotyping to deliver new biological insights.
Inflation continues to take a toll on U.S. FDA drug and device user fees with some of the fees increasing as much as 44% for fiscal 2025. While most fee increases for generics and innovative drugs and biologics are below 10%, the ANDA fee is jumping 28% to $321,920.
Esperto Medical Inc. could soon offer a non-invasive method for blood pressure measurement for critically ill patients based on results seen in a study published in PNAS Nexus. Esperto’s Resonance Sonomanometry technology uses acoustic stimulation with ultrasound imaging to provide continuous, non-invasive readings.
Stryker Corp. continued its recent buying spree with the purchase of Molli Surgical Inc., a company that develops wire-free soft tissue localization technology for breast-conserving surgery. Styker said Molli’s offerings strengthen its advancing surgical solutions in breast cancer care.
U.S. federal preemption of state law for devices approved by the FDA is a matter of record, but a recent case affirms the staying power of Supreme Court jurisprudence on that point.
Radiopharmaceutical company Telix Pharmaceuticals Ltd. received a U.S. FDA refusal to file letter for its BLA seeking approval of renal cancer imaging agent TLX250-CDx (89Zr-DFO-girentuximab) for clear cell renal cell carcinoma (ccRCC).
Noze Inc. breathes a little easier with a new $5 million equity investment from the Bill & Melinda Gates Foundation to support the development of Diagnoze, a breath-based, hand-held diagnostic device. The foundation provided two earlier grants focused on diagnosing tuberculosis in low- and middle-income countries. “We're thrilled to see our partnership with the Bill & Melinda Gates Foundation continue to grow,” Noze CEO Karim Aly told BioWorld.
The proposal to overhaul the use of terminal disclaimers in U.S. patent filings won over no fans among former directors of the U.S. Patent and Trademark Office, but device and drug makers, too, are concerned about the proposal.
The U.S. Agency for Healthcare Research and Quality posted a request for information on the current state of multi-cancer screening tests for a review that poses several questions.