After a flood of deals with special purpose acquisition companies (SPACs) that took dozens of med-tech and biotech companies public in 2021, deal flow slowed to a trickle in 2022. Market conditions factored into the collapse of interest, but regulatory changes also played a significant role. Still, several notable companies made their market debuts via SPACs in 2022 – and one changed its mind mid-stream. Read More
The fifth medical device user fee agreement (MDUFA V) included several new programs, such as a program intended to aid device makers in an efficient to-market process. However, MDUFA V also boosted device user fees for many applications by 55% but turnaround times for these applications will remain essentially flat compared to MDUFA IV. Read More
Movano Inc., dba Movano Health, expects to launch its medical-grade smart ring, Evie, on a one-time cost basis in 2023. The digital wearable, which is designed specifically for women, collects a range of health and wellness metrics, and translates them into personalized, actionable insights for wearers and their doctors. Read More
Remedee Labs SA raised $13.25 million to accelerate the commercial deployment of its mini endorphin stimulator for chronic pain. This is the company’s third funding round after initial fundraising of $11.66 million. Read More
Although the war is still raging in Ukraine, Russia is marching forward with asserting its regulatory framework on health care in the parts of Ukraine it’s claiming as the spoils of the war it started 11 months ago. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abiosciences, Biostage, Iqvia, Mission Bio, Pixium Vision, Second Sight Medical Products, Vivani Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Polarean Imaging. Read More
