From softwares to implants, here are 10 spine products earning FDA nods since May 15. 1. Accelus’ FlareHawk interbody fusion device was FDA-cleared for use in MRI scanning under certain conditions.

Imperative Care, Inc. announced the FDA 510(k) clearance of and first patient cases with its Zoom 7X catheter for aspiration ...

The FDA approved an expanded access program for troculeucel, making the treatment available to patients outside clinical trials.

Just when the future looked bleak for GSK’s Blenrep comeback in the U.S., the FDA has blessed the company's multiple myeloma ...

The company plans to make the diagnostic available to physicians and researchers this summer, expanding its portfolio beyond ...

Elekta announced today that it received FDA 510(k) clearance to expand indications for its Leksell Gamma Knife radiosurgery ...

Rocket Pharmaceuticals RCKT announced that the FDA has granted the Regenerative Medicine Advanced Therapy (RMAT) designation ...

"It's called an alternate bearing surface, called Pyrocarbon," said Dr. E. Scott Paxton with University Orthopedics.

Moderna’s Covid vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S.

The integration of artificial intelligence (AI) in the cardiovascular space, particularly in electrocardiography (ECG), is reshaping clinical workflows, enabling earlier disease detection and opening ...

Pear Therapeutics and Sandoz, a division of pharmaceutical company Novartis, launched reSET-O, a digital therapeutic for opioid use disorder, Jan. 7. The FDA cleared reSET-O in December, making it ...

This latest approval builds on an earlier liquid formulation of generic methimazole for feline hyperthyroidism, which ...