Neuronetics Inc., of Malvern, Pa., has won U.S. FDA breakthrough device designation for its Neurostar transcranial magnetic stimulation device for the treatment of patients with drug-resistant bipolar depression. The news comes as the company reported a strong fourth quarter for 2019, with revenue up 11% year-over-year to $17.4 million.

Advamed’s Van Meter: ‘Now is the time’ to act on LDT regulatory reform

The latest version of legislation for regulatory reform has arrived, and the conventional wisdom may be that the so-called VALID Act will not be passed until the next user fee agreement is codified into law. Nonetheless, Susan Van Meter, executive director of Advameddx, told BioWorld that the associated reforms are urgently needed by patients and test developers alike, and said, “now is the time to do comprehensive diagnostic regulatory reform.”

Canadian ultra-fast 3D printing to help German company’s expansion into medical devices

TORONTO – Vancouver, British Columbia-based Newpro3D Inc. has put its ultra-fast 3D printing technology at the disposal of Henkel AG & Co. KGaA to help it expand into production scale, additive manufacturing of medical devices. Newpro’s technology features a transparent wettable membrane chemically designed to facilitate faster production of hard and soft anatomical models used by medical educators. This eliminates the slow mechanical processes in more conventional 3D printing techniques, the company said.

Ibex secures CE-IVD mark for AI-powered decision support system for cancer

LONDON – Ibex Medical Analytics is preparing for commercial rollout in Europe after receiving CE-IVD marking for its artificial intelligence decision support system for automated interpretation of prostate cancer biopsies.

Australia unveils new regulatory framework for custom-made and 3D-printed devices

PERTH, Australia – After more than three years of consultations, Australia’s Therapeutic Goods Administration finally has unveiled a new regulatory framework for custom-made and 3D-printed devices that aligns with international standards.

Also in the news

Aguair, Daxor, Ehealth Technologies, Enzo Biochem, Invivo Therapeutics, Kldiscovery, Labcorp, Lifesci Acquisition, Mologic, Neuronetics, Pacific Biosciences, Preludedx, Rochester Rhio, Silk Road Medical, Sona Provides, Sparta Science, Spectra Medical, Transenterix