With virtually bent knees and proper posture, Soter Analytics Pty Ltd. raised $12 million in a series A funding round to build on its artificial intelligence (AI)-based ergonomic wearables line that helps workers minimize injuries on the job. The technology tracks all significant shoulder and back movements and provides personalized real-time feedback before improper lifts or twists land users on their backs or in rehab. Read More
The U.S. FDA’s draft device user fee agreement was months late in arriving on Capitol Hill, a fact which also delayed the public meeting on the draft, an event that finally took place April 19. The meeting kicked off with an acknowledgement by second-time FDA commissioner Robert Califf of the growing role of user fees in FDA finances, but Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), said that the quality of FDA reviews was at least as important as the timeliness of those reviews even though the user fee deals include many deadline-based metrics. Read More
Acotec Scientific Holdings Ltd. has received marketing approval for its radiofrequency ablation system from China’s NMPA to treat varicose veins. The radiofrequency ablation system consists of an endovenous radiofrequency catheter and a radiofrequency generator. Read More
Perkinelmer Inc. said the Vega is a first-of-its-kind preclinical ultrasound system that will accelerate preclinical research and drug development studies of cancer, cardiovascular, liver, kidney and other diseases. The imaging platform combines hands-free automation with high-throughput capability, which the company said is a major advance over manual ultrasound scanning across the bodies of individual lab mice. Read More
The U.S. FDA’s device center reported April 18 that it has revoked the emergency use authorizations (EUAs) for five tests for the SARS-CoV-2 virus, a seemingly significant reduction in the inventory of tests for the COVID-19 pandemic. However, the sponsor of the test in each of these revocations requested that the EUA be revoked, an indication that the market for some types of these tests is saturated. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abk Biomedical, Applied Cells, Assure, Cureclick, Cydar, Healogics, Medtronic, MGI Tech, Nalagenetics, Si-Bone, Stemcell Technologies, Thread, Virtual Incision. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bendit Technologies, Cosara, Genetron, Ihealthscreen, Microgem, Smart Medical Systems. Read More
