Magstim Inc. received U.S. FDA clearance for use of its Horizon 3.0 and E-z Cool Coil to treat adult patients diagnosed with both obsessive compulsive disorder (OCD) and major depressive disorder (MDD). The company’s non-invasive transcranial magnetic stimulation (TMS) therapy offers an option for patients who do not find adequate relief from the often life-disrupting symptoms of OCD with exposure therapy or medication. Read More
The fifth medical device user fee agreement (MDUFA V) is a generous bump in monies for the U.S. FDA, some of which will go toward advancing the use of real-world evidence (RWE) in the agency’s regulatory decisions. The FDA just opened a docket for comment on how those monies might be doled out to entities other than the Medical Device Innovation Consortium (MDIC), an expansion that might nudge the regulatory science along a little more quickly and thus enhance the use of RWE for premarket submissions. Read More
Qitan Technology Co. Ltd. has raised ¥700 million (US$104 million) in a series C round led by Meituan Inc. to improve its nanopore sequencing devices and expand its market. Read More
The U.S. Department of Health and Human Services received low marks on its latest Government Accountability Office (GAO) report card for its oversight of high-risk research involving potential pandemic pathogens, but legislative fixes might be necessary to ensure that all the gaps are closed. Read More
While the fourth quarter (Q4) of 2022 raised the most money of any quarter this year, the overall amount collected through med-tech financings – $38.3 billion – is still 22.3% less than 2021’s $49.3 billion raised. Read More
In the absence of a European framework, industry is stepping up with an initiative to help EU patients cross borders to participate in clinical trials. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Endonovo, Foundation Medicine, Genetron Health, Greenbrook TMS, Guardant, Immunovia, Intraop, Machine Solutions, Neuronetics, Sofpulse, Surmodics, Vela Technologies. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Selux. Read More
