By Ronald Boumans, Emergo Group On September 27, 2020, the Swiss held one of their many referendums. Due to the COVID-19 pandemic the referendum in May 2020 had been postponed. This resulted in a total of five issues they were asked their opinion about, so the Swiss had to do a bit of homework before […]
FDA clears WishBone Medical pediatric external fixation device
WishBone Medical this week announced that it received FDA 510(k) clearance for its pediatric Smart Correction external fixation system. The device features hexapod external fixator hardware and planning software for a higher accuracy and design that enable surgeons to perform strut replacement procedures. It is designed to stabilize and maintain alignment of complicated fractures, soft […]
Diversity in medtech: Just 20% of executive roles held by women
Diversity in executive roles in the medical device industry is trending more toward parity, with women holding 2% more C-suite roles in 2020 compared to last year. Just 20% of executives at the 100 largest medical device companies in the world are women, and those companies average 19% female composition in the C-suite, according to […]
The top 10 medical disruptors of 2021
For the past 18 years, the Cleveland Clinic has predicted what the top 10 medical disruptors will be for the following year. The list of technologies, cultivated by a panel of physicians and scientists at the clinic, was led by Dr. Will Morris, executive medical director of Cleveland Clinic Innovations, and Dr. Akhil Saklecha, managing […]
TriSalus names new chief medical officer
TriSalus today said it appointed Steven Katz as chief medical officer. Katz will be responsible for overseeing the company’s clinical development strategy in the treatment of solid tumors. He has served as TriSalus’s chief medical advisor and chairperson of its scientific advisory board since 2018. “We are thrilled to have Steven join TriSalus as a […]
Japan PMD Act revises fast-track reviews for some medical devices, IVDs
By Stewart Eisenhart, Emergo Group Significant revisions to Japanese regulations of medical devices, IVDs and other healthcare products have begun taking effect, with phased implementations (link in Japanese) of new and updated requirements planned through 2022. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
CoreLink launches OLIF instrument set
CoreLink this week announced the limited commercial release of its Oblique Lumbar Interbody Fusion (OLIF) Instrument Set. The OLIF technology is a less invasive approach to the lower lumbar spine for faster recovery times and minimized psoas disruption. “The addition of OLIF instrumentation bolsters our minimally invasive spine surgery options and builds on our robust […]
Johnson & Johnson’s Cerenovus launches new clot removal devices to treat stroke
Johnson & Johnson’s Cerenovus recently announced it has launched its new stroke solutions platform that includes three devices for clot removal procedures. The three devices are designed to aid physicians in performing mechanical thrombectomy procedures. The devices include the Cerebase DA Guide Sheath, Cerenovus Large Bore Catheter and Embotrap III Revascularization Device. Get the full […]
India regulators propose medical device, IVD extensive risk classification lists
By Stewart Eisenhart, Emergo Group Indian healthcare regulators at the Central Drugs Standard Control Organization (CDSCO) have issued substantial new risk-based classification lists for medical devices and IVD products in order to clarify regulatory pathways and requirements. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]
U.K. regulators issue new post-Brexit medical device regulatory compliance guidance
By Evangeline Loh and Ronald Boumans, Emergo Group The UK Medicines and Healthcare products Regulatory Agency (MHRA) has posted new guidance regarding medical devices placed on the market in Great Britain (and Northern Ireland and European Union (EU)) starting January 1, 2021. This is of course in the event of an anticipated hard Brexit. Get […]
InspireMD wins FDA approval for carotid stent system study
InspireMD today said it received FDA approval to proceed with a pivotal study of its CGuard Carotid Stent System. The investigational device exemption from the FDA will allow the company to study the device for the prevention of stroke in patients in the U.S. Get the full story on our sister site, Medical Tubing + […]