3B Scientific this week said it entered an agreement to acquire iSimulate for an undisclosed amount. Canberra, Australia-based iSimulate offers medical simulation training and clinical education technology. “iSimulate has revolutionized simulation training in healthcare through its creative simulation solutions including ALSi, REALITi, CTGi and AURiS,” 3B Scientific CEO Todd Murray said in a news release. […]
StimGuard appoints new chief financial officer
StimGuard today said it appointed Stephen Deitsch as chief financial officer, effective Jan. 15. Deitsch has 20 years of corporate financial leadership experience in medtech and healthcare. He replaces interim chief financial officer Gil Bao, who will transition into the role of director of strategy. “We are excited that Steve will be joining StimGuard’s executive […]
Mojo Vision developing ‘smart’ contact lens
Mojo Vision is working with the FDA to develop a smart contact lens to help people with low vision. The lens overlays real-time contrast and lighting enhancements with zoom functionality and recently won FDA breakthrough device designation. “Receiving the Breakthrough Device Designation is a significant step in our research and development process. We look forward […]
Owens & Minor plans to sell Movianto business
Owens & Minor (NYSE:OMI) this week announced it intends to sell its European logistics business Movianto to EHDH Holding Group. “Owens & Minor is laser-focused on our mission to empower our customers to advance healthcare. While Movianto has been an important part of the Owens & Minor family, the intended transaction would advance Owens & Minor’s […]
Supporting regulatory affairs departments to address clinical requirements under new MDR
By Dietmar Falke and Jaap Laufer, Emergo Group The May 25, 2020 MDR deadline is approaching rapidly, and by now many medical device manufacturers are aware that the MDR requires the proactive collection of post-marketing clinical follow-up (PMCF) data. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog […]
Medline Industries acquires Médi-Sélect
Medline Canada today said it acquired Médi-Sélect for an all-cash transaction for an undisclosed amount. Médi-Sélect will stay as an independent division of Medline Canada throughout the rest of the year and will be headed by its current president Philippe Cantin. He will report to the president of Medline Canada Ernie Philip. “Médi-Sélect and Medline […]
Proteus pivots, hands digital mental health adherence business to Otsuka
Proteus Digital Health is abandoning its mental illness and cardiovascular work in its digital pill technology after its deal with Otsuka Pharmaceutical (TYO:4578) ended prematurely and will start to focus more on therapeutic areas, STAT News reports. Otsuka Pharmaceutical had been paying Proteus to develop a portfolio of digital medicines for serious mental health conditions. […]
FDA recognizes latest ISO 14971 as medical device consensus standard
By Mark Leimbeck and Stewart Eisenhart, Emergo Group The US Food and Drug Administration has granted Recognized Consensus Standard status to the third edition of the ISO 14071 risk management standard for medical devices and IVD products. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]
Neovasc Reducer gains FDA PMA review
Neovasc said it received FDA administrative acceptance review notification for its Reducer device. Reducer is designed to treat refractory angina, which occurs when the coronary arteries deliver an inadequate supply of blood to the heart. “I would like to reiterate my thanks to the entire Neovasc team for their tireless efforts to complete the submission […]
Okapi Medical appoints new CEO on heels of successful pre-clinical study
Okapi Medical this week appointed Darren Obrigkeit as CEO and announced the successful pre-clinical study of the company’s wound closure technology. Obrigkeit has more than 20 years of experience in the medical device industry and has held leadership roles internationally for startups and large companies. “I’m thrilled to join the Okapi team,” Obrigkeit said in […]
T2 Biosystems names new chief commercial officer
T2 Biosystems (NSDQ:TTOO) this week appointed Tony Pare as chief commercial officer, effective immediately. Pare previously served as VP and general manager of international at the company. The chief commercial officer role was a newly created position within T2 Biosystems. “I am delighted to appoint Tony as our chief commercial offer and look forward to working […]