Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Endoquest, Diamicron, Henry Schein, Optimed, Orasure, Zylox-Tonbridge.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BD, Elekta, Proprio.
The U.S. FDA has endorsed ISO 14971 for risk management for medical device manufacturers, but there’s nothing compulsory about industry’s use of this standard. Nonetheless, Sarah Moore, principal program lead at NSF, told BioWorld that adoption of 14971 is still the most seamless way to demonstrate proper risk management practices to FDA field investigators, given that the alternative is almost always more work for both sides during facility inspections.
Distalmotion SA recently secured a strategic investment from Johnson & Johnson for its robotic-assisted surgical system Dexter, amid an increase in demand from ambulatory surgery centers for such platforms. The deal follows Distalmotion’s $150 million in a series G financing, and coincides with J&J’s recent submission of its own robotic surgical system, Ottava, to the U.S. FDA., for clearance.
Boston Scientific Corp. looked ready to keep steamrolling down the acquisition path, carrying the momentum from last year, with the news that it is acquiring Penumbra Inc., a company that makes devices for interventional therapies to treat vascular conditions such as stroke and aneurysm, for a whopping $14.5 billion.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Billiontoone, Femasys, Hyperfine, Robotron Surgical, Staar Surgical, VB Spine.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ASP, Camdiab, Fujifilm Healthcare Europe, Vizmark, Ypsomed.
The sea anemone Stichodactyla helianthus, which carpets the Caribbean seafloor, may hold the key to eliminating the senescent cells that survive cancer therapy. A collaboration led by Spanish scientists across several international research centers has discovered a new type of toxin that selectively eliminates senescent cancer cells.