NanoVibronix (NSDQ:NAOV) announced today that it received FDA enforcement discretion for the U.S. distribution of the UroShield device. According to a news release, the FDA exercised its enforcement discretion, giving Elmsford, N.Y.-based NanoVibronix’s UroShield an intended use code (IUC), clearing the way for the import of the system to the U.S. amid the COVID-19 pandemic. UroShield […]
Ultrasound
DTW Podcast: Truist’s Kaila Krum says Medtronic prepping for growth
In an interview with DeviceTalks Weekly Podcast, Truist Securities managing director Kaila Krum says Medtronic executives are retooling the company to keep pace with smaller, more focused competitors. Breaking down the company’s Q1 call, Krum says Medtronic is seen as a company that’s too big to grow market share quickly. On the call, new CEO […]
Exo raises $40M for handheld medical imaging tech
Exo announced today that it closed a $40 million Series B+ funding round for the development of its handheld medical imaging system. Redwood City, Calif.-based Exo’s handheld ultrasound device is designed to use patented piezoelectric micromachined ultrasound transducer (pMUT) technology to offer high-quality images, intuitive software and powerful diagnostic capabilities in the pocket of caregivers […]
Sanuwave completes Celarity buy
Sanuwave Health (OTC:SNWV) announced that it completed its acquisition of Celularity’s UltraMist ultrasound healing therapy platform. In June, the companies announced an exclusive agreement for the purchase, which includes exclusive partnership rights for Celularity’s wound care biologic products. Celularity develops allogeneic cellular therapies engineered from postpartum human placenta, in cancer, infectious disease and degenerative disease. Along with the […]
Insightec wins Medicare coverage for incisionless neurosurgery platform
Insightec announced today that it has secured complete Medicare coverage across the U.S. for its MR-guided focused ultrasound treatment of medication-refractory essential tremor. The coverage comes roughly four years since the Tirat Carmel, Israel–based company won FDA approval for the technology. Insightec officials said compelling clinical evidence and support from physicians, specialty societies and patients […]
Hologic launches first cart-based ultrasound system in U.S.
Hologic (NSDQ:HOLX) announced today that it launched its SuperSonic MACH 40 premium, cart-based ultrasound system in the U.S. The Marlborough, Mass.-based company touts the SuperSonic platform as its first cart-based system, saying in a news release that the new system features strong image quality, standard-setting imaging modes and design to enhance efficiency and accuracy. SuperSonic uses […]
Philips launches Lumify tele-ultrasound system in Japan
Royal Philips (NYSE:PHG) announced today that its Lumify with Reacts handheld tele-ultrasound imaging system is commercially available in Japan. Japan’s healthcare authority cleared Lumify for compatible handheld devices in its healthcare market to make high-quality, portable ultrasound available almost everywhere in the country, according to a news release. Lumify is designed for use in places where […]
Sanuwave announces intent to acquire Celularity’s UltraMist
Sanuwave Health (OTC:SNWV) announced that it entered into an exclusive agreement to acquire Celularity’s UltraMist ultrasound healing therapy platform. The non-binding letter of intent includes the acquisition of UltraMist and exclusive partnership rights for Celularity’s wound care biologic products, according to a news release. Celularity develops allogeneic cellular therapies engineered from postpartum human placenta, in cancer, […]
Philips lands 510(k) to market ultrasound systems for COVID-19
The FDA has granted Royal Philips (NYSE:PHG) 510(k) clearance to market a wide range of its ultrasound systems to help manage COVID-19-related lung and cardiac complications. Handheld and portable ultrasound solutions in particular have become valuable tools for clinicians treating COVID-19 patients due to their imaging capabilities, portability and ease of disinfection, according to Philips. The 510(k) […]
Insightec raises another $150m for incisionless neurosurgery platform
Insightec announced that it signed definitive agreements for a $150 million Series F financing round with a post-money valuation of $1.3 billion. The Haifa, Israel–based company is the developer of the Exablate Neuro incisionless neurosurgery platform. Insightec touts the Exablate Neuro as the first MR-guided focused ultrasound device to win FDA approval for treating certain […]
Philips signs 8-year partnership with Paracelsus Clinics
Royal Philips (NYSE:PHG) and Paracelsus Clinics announced today that they entered into an eight-year strategic partnership to continue modernizing Paracelsus Clinics’ medical imaging systems. Switzerland-based Paracelsus Clinics intends to work with Philips on imaging system availability and equipment operation while strengthening efficiency and increasing quality, according to a news release. Paracelsus Clinics head of the procurement […]