The FDA today imposed stricter regulations on certain radiological medical image analyzers, reclassifying them from Class III to Class II. Affected products include computer-assisted detection (CADe) devices for breast cancer mammography, breast-lesion ultrasound, and lung-nodule and dental-caries radiography, the agency said. It defines these devices as those intended to identify, mark, highlight, or in any […]
Butterfly Network expands ultrasound access to Android devices
Butterfly Network announced that it expanded the compatibility of its Butterfly iQ imaging device to include 10 Samsung and Google devices, and added financing options from Affirm. Butterfly iQ is a handheld, single-probe whole-body ultrasound imaging system. The Guilford, Conn.-based company’s goal is to make ultrasound technology universally accessible and affordable. According to the company, […]
Study: Novel MRI-guided ultrasound treatment destroys prostate cancer
New research claims that the minimally invasive MRI-guided transurethral ultrasound ablation (Tulsa) treatment effectively treats prostate cancer with minimal side effects. The Tulsa method is designed to deliver precise doses of sound waves to diseased prostate tissue while sparing the healthy nerve tissue that surrounds the prostate. The method rivals current techniques that lack sophisticated […]
NanoVibronix wins reimbursement from CMS for PainShield device
NanoVibronix (NSDQ:NAOV) announced today that it won a unique reimbursement code from the Centers for Medicare and Medicaid for its PainShield surface acoustic wave portable ultrasonic therapeutic device. The Elmsford, N.Y.–based company develops medical devices based around its low-intensity SAW technology that allows the creation of low-frequency ultrasound waves that can be used in multiple medical […]
Ultrasound tech startup Sonavex raises $1.8 million
Sonavex has raised nearly $2 million in equity for its ultrasound-based blood flow monitoring and other technologies. According to an SEC Form D filed last week, Baltimore-based Sonavex made its first sale in the offering on Oct. 11 and has raised $1.8 million to date. The Johns Hopkins University spin-out listed an indefinite amount on […]
Surgical staplers top ECRI’s list of top medtech hazards
ECRI Institute said today that surgical stapler misuse is the top health technology hazard, beating out the likes of point-of-care ultrasounds and sterile processing errors. The ECRI Institute said it intends to help surgical stapler users avoid many of the common errors that can lead to patient harm by publishing the 13th edition of its Top […]
Bay Labs rebrands as Caption Health
Bay Labs said today that it is renaming the company Caption Health and rebranding its flagship technology, EchoGPS, as Caption Guidance. The San Francisco-based company plans to incorporate Caption Guidance technology into compatible ultrasound devices and offer that product to the market as Caption AI. Caption AI is designed to allow for quick and accurate […]
U.S. exempts more Chinese medtech products from tariffs
The U.S. has exempted another 18 medical devices or device components from the 25% tariffs imposed on Chinese goods by the Trump administration. The new list includes ultrasound, X-ray, MRI and infusion equipment. The Office of the U.S. Trade Representative (USTR) said the new exclusions are retroactive to August 23, 2018, when additional tariffs went […]
MedTech Innovator announces five finalists in competition
MedTech Innovator last week announced the five finalists for its $500,000 competition. The organization will award more than $500,000 in prizes to the finalists with first place taking $350,000 and the four remaining finalists taking $25,000. Five finalists will have seven minutes to pitch their technologies to a panel of four judges. The audience will […]
Philips, B. Braun launch Onvision needle tip tracking device
Royal Philips (NYSE:PHG) and B. Braun Melsungen today announced the launch of the Onvision ultrasound guidance solutions for needle tip tracking. Onvision is designed to track needle tips in real-time during regional anesthesia. It is available on the latest version of the B. Braun and Philips Xperius ultrasound system and allows anesthesiologists to accurately position the […]
SoniVie wins FDA breakthrough device designation for pulmonary hypertension device
SoniVie last week won FDA breakthrough device designation for its Therapeutic Intra-Vascular Ultrasound System for patients with pulmonary arterial hypertension. The Therapeutic Intra-Vascular Ultrasound (TIVUS) System is a dedicated therapeutic ultrasound catheter that enhances the treatment of PAH, according to the company. It is inserted into the pulmonary artery during right heart catheterization and is […]
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