MedTech News
Boston Micro Fabrication Launches ‘industry first’ hybrid micro-precision 3D printer series
The microArch D1025 Dual-Resolution 3D printer delivers the additive manufacture of parts that require micron-level precision and repeatability, with potential uses in the healthcare and life sciences fields.
Profound Medical wins FDA clearance for AI to support prostate cancer procedure
Profound Medical (Nasdaq:PROF) announced today that it received FDA 510(k) clearance for its second AI model for treating prostate cancer.
FDA warns not to use Cue Health COVID-19 test kits
The FDA has warned that home test users, caregivers and healthcare providers should not use Cue Health COVID-19 diagnostics.
Carthera wins U.S., EU orphan drug designation for SonoCloud
Carthera announced today that it received FDA and European orphan drug designation (ODD) for the use of carboplatin with its SonoCloud.
Olympus Announces Launch of Bronchoscopes Compatible with EVIS X1™ Endoscopy System
CENTER VALLEY, Pa., May 13, 2024 /PRNewswire/ — Olympus, a global medical technology company, announced today the launch of two bronchoscopes as part of the EVIS X1 Endoscopy System. The EVIS X1 Endoscopy System represents the latest in diagnostic and therapeutic bronchoscopy from Olympus.
Medtronic pulsed field ablation system wins approval in Japan
Medtronic (NYSE: MDT)+
announced today that its PulseSelect pulsed field ablation (PFA) system has won regulatory approval in Japan.
FDA Clears the Individualized Nomogram for Rika Plasma Donation System
LAKEWOOD, Colo., May 9, 2024 /PRNewswire/ — Terumo Blood and Cell Technologies (Terumo BCT), a medical technology company, recently received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Rika Plasma Donation System™ with the iNomi™ Nomogram. This innovation means that plasma collection volume can be determined by an individual donor’s height, weight and hematocrit level on the day they donate plasma.
Orthofix wins FDA 510(k) clearance for Rodeo Telescopic Nail
Orthofix (Nasdaq: OFIX)+
today announced it received FDA 510(k) clearance for its Rodeo Telescopic Nail.