Route 92 Medical Inc., of San Mateo, Calif., reported a class I recall of nearly 1,000 microcatheters because of reports of separation of the distal tip of the catheter, which is associated with two injuries and one reported death. The company indicated that the problematic catheters had been manufactured by an unidentified contract supplier, once again highlightingthe hazards of a failure to properly oversee the contract manufacture of critical medical devices.
Med-tech deal value increased in April, reaching $172.37 million, a 538% bump from March’s $27 million. However, the monthly average for deal value in 2024 stands at $140.68 million, reflecting an 84% decline from the 2023 monthly average of $886.13 million.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcscan, Clew Medical, Qiagen.
Medtronic plc teamed up with healthtech software company Modernizing Medicine Inc. (ModMed) to make colonoscopy procedures more efficient by integrating data generated from Medtronic’s GI Genius system into ModMed's gGastro EHR software to enhance endoscopic care.
The U.S. FDA’s final rule for lab-developed tests was a long time in coming even if the agency shorted the public comment period for the draft rule, and the final rule makes several major concessions about circumstances in which the agency would exercise enforcement discretion.
Imaging is the number one way physicians track cancer progression and burdens within neurology and cardiology, but the ability to take imaging information and interact with it to make better decisions is becoming ever more complicated.
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