Tianjin Usights Ophthalmology Technology Co. Ltd.’s ophthalmic fiberoptic microcatheter system has been approved by the NMPA for marketing for minimally invasive glaucoma surgery (MIGS) in China. Tianjin, China-based Usights claims this is the first homegrown products for MIGS in China that has been approved.
Axoft Inc. emerged from stealth mode with an $8 million seed round led by The Engine, the Massachusetts Institute of Technology’s venture spinout for early-stage tech startups. The funds will be used to conduct preclinical studies and scale up prototypes of its supple brain implant technology.
Australia’s TGA has opened a consultation on drug-device combination products to help sponsors understand the regulatory pathway through which their products will likely pass since these combination products may not fit within existing definitions for drugs, biologicals or medical devices.
Curvebeam AI Ltd. won a U.S. FDA breakthrough device designation for Ossview, its investigational software that detects osteopenia or reduced bone mass in the already fragile bones of women 70 years of age and older. Osteopenia is difficult to diagnose using conventional bone mineral density (BMD) testing because small changes in density mask major changes in bone microstructure.
The Verifying Accurate Leading-edge IVCT Development (VALID) Act has been floating around Capitol Hill for the past four years, but was once again left by the wayside when Congress passed the latest round of U.S. FDA user fee legislation. Scott Whitaker, president and CEO of the Advanced Medical Technology Association, said in a press briefing that the prospects for the legislation dim considerably if Congress does not pass the VALID Act by the end of the calendar year, raising the prospect that the FDA will act unilaterally to engage in rulemaking to deal with regulation of lab-developed tests.
Limacorporate SpA reported U.S. FDA approval for Prima, its new shoulder platform focused on versatility and operating roam efficiency. “For the first time in our history, both the glenoid base plate and humeral stem are fully 3D-printed, leveraging our long legacy in additive manufacturing,” Massimo Calafiore, CEO of Limacorporate, told BioWorld.
Australia’s TGA has opened a consultation on drug-device combination products to help sponsors understand the regulatory pathway through which their products will likely pass since these combination products may not fit within existing definitions for drugs, biologicals or medical devices.
The U.S. FDA’s agreement with industry for the fifth device user fee agreement (MDUFA V) included a pilot for the total product life cycle advisory program, or TAP, which is designed to ensure that potential device problems are addressed before production of the finished device design. However, the agency acknowledged that the TAP program will require significant numbers of new hires, which promises to be a significant hurdle given that the agency struggled to meet its hiring goals under the previous device user fee agreement.
Applied Tissue Technologies LLC (ATT) has won U.S. FDA clearance for a negative pressure wound therapy (NPWT) system that eliminates foam as a potential impediment to complete wound healing. ATT CEO Michael Broomhead said negative pressure wound therapy is ripe for a true innovation to kick its Platform Wound Dressing (PWD) and the treatment “into its next generation.”
