Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Intelivation, Johnson & Johnson Vision, Joimax, Neuroone, Royal Biologics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic, Siemens Healthineers, Transmedics.
Multiple sizes of Neptune Medical LLC’s overtube for gastrointestinal (GI) procedures that allows thin-walled tubes to toggle between flexible and rigid states received FDA clearance. With the clearance, the Burlingame, Calif.-based company now has nine sizes of cleared single-use overtubes with more in the wings. The Pathfinder endoscope overtube device uses Neptune’s Dynamic Rigidization technology to keep tubes from looping during procedures, a problem that leads to procedure failure, patient pain and complications in colonoscopy and other GI procedures.
Rokit Healthcare Inc. received approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for Dfurege, its artificial organ platform to treat diabetic foot ulcers. “We hope that having a South Korean approval for this platform will be a boost for our planned IPO,” Seok Hwan You, CEO at Rokit, told BioWorld.
Aatru Medical LLC has received FDA 510(k) class II clearance for a platform that turns its back on electro-mechanical components in other negative pressure wound therapy (NPWT) systems. Deployed for closed surgical incision applications, the Negative Pressure Surgical Incision Management System (NPSIMS) is a single-use, disposable platform that could help reduce the 20% of hospital infections attributed to surgical site infections (SSI).
Even as the Biden administration pushes for drug imports from Canada as a way to help curb U.S. prescription drug prices, Canada is doubling down on its efforts to protect its supply of drugs and medical devices.
The Medical Device Innovation Consortium (MDIC) has launched a digital health initiative that will aid the FDA in its efforts to devise a workable regulatory system for these products, which includes a work stream for change control. This work stream promises to be a massive effort, but Joe Sapiente, MDIC's vice president for clinical science and technology, told BioWorld that MDIC needs subject matter experts in this and several other areas to sustain the group’s momentum and thus aid the FDA’s efforts to produce guidance for digital health products.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has initiated proceedings in the Federal Court of Australia against Medtronic Australasia Pty Ltd. for alleged unlawful supply of its Infuse bone graft kit, which contains a medicine and other components to stimulate bone growth in patients.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Asensus Surgical, Endosound, Immunolight, In2bones, Intelivation Technologies, Rehabtronics, Tyber Medical.
U.S. Attorney General (AG) Merrick Garland has rescinded two important policy documents, including the Brand memo, which limited the ability of federal prosecutors to use non-compliance with federal agency guidance as proof of violations of the law. The rescission of these memos increases the risk that drug and device companies will be prosecuted more vigorously due to deviation from FDA guidance documents, which at times conflict with other guidances and thus may create a series of nearly unavoidable compliance failures.
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