The U.S. FDA granted Sooma Oy breakthrough device designation for its patient-administered neuromodulation device to treat depression. Sooma Depression Therapy uses a mild electrical current to stimulate targeted brain areas, resulting in a significant improvement in depressive symptoms. Read More
The FDA’s device center just released three performance reports related to the fourth and fifth device user fee agreements, including a financial report that shows the agency collected far more in user fees than it spent for fiscal year 2022, yielding a carryover amount of more than $142 million. One of the more interesting aspects of the report is that because the taxpayer dollars used for FDA’s device inspections did not meet a pre-specified amount for two consecutive years, third-party inspections for FDA compliance purposes have been disallowed for fiscal year 2023, making hash of a program sought by domestic manufacturers who distribute their products to other nations as well as in the U.S. Read More
The European Council applied its seal of approval to a proposal to extend the deadlines for the Medical Device Regulation (MDR), providing industry some critical breathing room to obtain certification for devices brought to market under the legacy Medical Device Directive (MDD). Read More
Proteor SAS is launching the Synsys bionic leg, a sensor-equipped microprocessor-controlled knee-ankle-foot prosthetic leg for above-the-knee amputees. This new generation prosthesis coordinates knee and ankle movements simultaneously as an extension of the hip, enabling smoother, more natural movement on a variety of surfaces. Read More
Johnson & Johnson’s Biosense Webster division reported that its Qdot Micro diagnostic and ablation deflectable tip catheter secured approval for marketing in China from the National Medical Products Administration where options for treating arrhythmias are seeing growing demand. A radiofrequency (RF) ablation catheter, Qdot Micro reduced total ablation procedure time by nearly 90 minutes. Read More
New hires and promotions in the med-tech industry, including: Accelerate Diagnostics, Aditxt, Aim Medical Robotics, Endoluxe, Heartbeam, Ivy Fertility, Maternova, Osteocentric, Swift Medical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alimetrix, Aribio, Fujirebio, Microarrays, Miromatrix, Pharmajet, Sengine, Spectrum Solutions. Read More
