The FDA labeled a recall of Olympus bronchoscopes that could lead to burns or fire Class I, the most serious kind. Olympus reports 192 complaints related to the issue, including four injuries. The company has received no reports of death. This recall — a correction, not a product removal — applies to Olympus bronchofiberscopes and […]
Imaging
Medtronic has a Class I recall for its surgical navigation software
The FDA deemed the recall of Medtronic StealthStation S8 software Class I, the most serious kind. This recall — a correction, not a product removal — relates to StealthStation S8 Application Version 2.0 and 2.0.1. It affects 2,109 devices distributed in the U.S. between Jan. 7, 2022, and Oct. 2, 2023. Medtronic initiated the recall […]
Butterfly Network to bring Ultrasound-on-Chip tech to surgical robotics
Butterfly Network (NYSE:BFLY) announced today that it partnered with Mendaera to commercialize a new surgical robotic system. Mendaera, a Silicon Valley-based company, develops medical robotic technology. Its platform combines robotics, real-time imaging, AI and connectivity to enable intervention at scale. The company recently completed the research and design process for its novel robotic system and […]
Luma Vision raises $22M for 4D cardiac imaging, navigation tech
Luma Vision announced today that it raised $22 million to support its bid for FDA clearance of its Verafeye imaging and navigation platform. The company, headquartered in Dublin, Ireland, and Munich, Germany, develops novel four-dimensional (4D) technology. It designed Verafeye for cardiac imaging and navigation and has plans to build next-generation versions for additional applications. […]
Shifamed’s Laza Medical closes $36M Series A to support cardiac imaging tech
Laza Medical, the latest Shifamed portfolio company, announced today that it closed a Series A financing worth $36 million. The latest positive news for a Shifamed company follows multiple milestones over the course of 2023. In June, Shifamed’s Adona Medical unveiled a next-generation heart failure management portfolio. In October, its Akura Medical unit raised $35 […]
Haemonetics completes $255M OpSens acquisition
Haemonetics announced today that it completed its previously announced acquisition of cardiology-focused medical device company OpSens. Boston-based Haemonetics first announced plans to buy OpSens for more than $250 million in October. Upon completion of the deal, the company acquired all outstanding shares at a fully diluted equity value of about $255 million. As a result, […]
Medtronic, Cosmo Pharma expand AI collab for GI Genius
Medtronic announced today that it agreed to expand its partnership with Cosmo Intelligent Medical Devices. The medtech giant aims to build upon already realized achievements with the Cosmo Pharmaceuticals subsidiary. Their AI-driven partnership centers around the GI Genius intelligent endoscopy module. Through the exclusive, global partnership, Medtronic and Cosmo seek to revolutionize endoscopy by utilizing […]
FDA clears neuro ablation tech from NeuroOne
NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that the FDA granted 510(k) clearance to its OneRF ablation system. Clearance makes OneRF the first FDA-cleared, thin-film, sEEG-guided radiofrequency (RF) system capable of recording electrical activity and ablating nervous tissue. The system, which also features temperature control, became the third FDA-cleared device at NeuroOne. It’s the first therapeutic […]
AdvaMed picks GE HealthCare CEO Peter Arduini as new chair, forms medical imaging division
AdvaMed today announced the appointment of GE HealthCare CEO Peter Arduini as its board chair as it establishes a medical imaging division. Arduini takes over the board chair spot from former Johnson & Johnson MedTech head Ashley McEvoy. McEvoy resigned from her position at J&J in October and subsequently stepped down as AdvaMed chair less […]
Sony, Olympus to collab on next-gen endoscopes
Olympus announced today that it agreed to a new business alliance with Sony over medical devices — specifically endoscopes. The two companies first entered into a collaboration in September 2012, establishing Sony Olympus Medical Solutions. The joint venture aimed to combine Olympus’ lens and optical technologies, plus brand and R&D, with Sony’s broad range of […]
Ambu has a reimbursement win for its single-use bronchoscope
Ambu announced today that CMS has approved a transitional pass-through (TPT) payment for its aScope 5 Broncho HD. The TPT payment, effective Jan. 1, 2024, will last for 24–36 months, allowing incremental reimbursement for outpatient procedures using the device. The aScope 5 Broncho HD series is Ambu’s latest generation of single-use bronchoscope. Cleared by the […]