The U.S. FDA accepted Telix Pharmaceuticals Ltd.’s new drug application for TLX-007-CDx, a new cold kit for preparing prostate-specific membrane antigen-PET imaging for prostate cancer.

Magenta Medical Ltd. raised $105 million in financing that will go toward clinical trials and to secure U.S FDA approval for its Elevate system, the world's smallest heart pump. The substantial investment haul was “a vote of confidence” from the investor community for what the company is doing, David Israeli, CEO of Magenta told BioWorld.

Spotlight Medical SAS recently raised €6.2 million (US$6.7 million) in seed funding to bring its first artificial intelligence-powered cancer test to the market as it looks to transform treatment of the disease. “We believe our personalized testing approach will revolutionize cancer treatment, providing everyone with the best possible chance to beat cancer,” Sylvain Berlemont, CEO of Spotlight told BioWorld.

New U.S. SEC rules designed to reel back the special purpose acquisition (SPAC) market went into effect on July 1, yet only a few weeks later two such companies completed IPOs and are now targeting mergers with health care and life sciences firms, including biopharma and medical technology.

Novocuff Inc. closed an oversubscribed $26 million series A funding round to support further development of the Novocuff cervical control system, which is designed to reduce preterm births by closing the cervix in high-risk pregnancies. The funds will enable the company to undertake a U.S. multi-center pivotal clinical trial, pursue marketing authorization, expand its team and begin early-stage commercialization of the device.

Loci Orthopaedics Ltd. raised €12.8 million ($14 million) in an oversubscribed series A funding round that will help bring its Indx implant system for thumb base joint arthritis to the market. “There is a major unmet clinical need in orthopedics extremities and thumb base joint arthritis is a highly and increasingly prevalent condition,” Brendan Boland, co-founder and executive chairperson of Loci, told BioWorld.